A RANDOMIZED CONTROL TRIAL COMPARING THE KING VISION...
Transcript of A RANDOMIZED CONTROL TRIAL COMPARING THE KING VISION...
1
A RANDOMIZED CONTROL TRIAL COMPARING THE
KING VISION VIDEO LARYNGOSCOPE AND THE D BLADE
OF THE CMAC VIDEO LARYNGOSCOPE IN PATIENTS
WITH C SPINE IMMOBILIZATION
A dissertation submitted to the Tamil Nadu Dr. M. G. R. Medical University, Chennai
in partial fulfillment of the requirement for the MD Anaesthesiology (Branch X)
degree examination to be held in April 2017.
2
A RANDOMIZED CONTROL TRIAL COMPARING THE
KING VISION VIDEO LARYNGOSCOPE AND THE D BLADE
OF THE CMAC VIDEO LARYNGOSCOPE IN PATIENTS
WITH C SPINE IMMOBILIZATION
Dissertation submitted to the
THE TAMIL NADU DR. MGR MEDICAL UNIVERSITY, CHENNAI
In partial fulfillment of the requirements for the degree of
MASTER OF MEDICINE
IN
ANAESTHESIOLOGY
By
JACOB CHANDY
Register number: 201520355
DEPARTMENT OF ANAESTHESIOLOGY
CHRISTIAN MEDICAL COLLEGE
VELLORE
APRIL 2017
3
CERTIFICATE
This is to certify that “A RANDOMIZED CONTROL TRIAL COMPARING
THE KING VISION VIDEO LARYNGOSCOPE AND THE D BLADE OF
THE CMAC VIDEO LARYNGOSCOPE IN PATIENTS WITH C SPINE
IMMOBILIZATION” is the bonafide work of Dr. Jacob Chandy under my
supervision in the Department of Anaesthesiology, Christian Medical College Vellore
in partial fulfillment of the requirements for the M.D Anaesthesiology Examination
Branch X of the Tamil Nadu Dr. M.G.R Medial University to be held in April 2017
and no part thereof has been submitted for any other degree.
Dr. Sajan Philip George
Professor, Department of Anaesthesiology
Christian Medical College,
Vellore
4
CERTIFICATE BY THE HEAD OF THE DEPARTMENT& PRINCIPAL This to certify that This is to certify that “A RANDOMIZED CONTROL
TRIAL COMPARING THE KING VISION VIDEO LARYNGOSCOPE
AND THE D BLADE OF THE CMAC VIDEO LARYNGOSCOPE IN
PATIENTS WITH C SPINE IMMOBILIZATION” is the bonafide work of
Dr. Jacob Chandy under the supervision of Dr.Sajan Philip George, Professor of
Anaesthesiology in the Department of Anaesthesia, Christian Medical College
Vellore.
Dr. Sajan Philip George Dr Anna P Pulimood
Professor and Head Principal
Department of Anaesthesiology Christian Medical College
Christian Medical College Vellore.
Vellore.
5
DECLARATION
I, Jacob Chandy, do hereby declare that the dissertation titled “A RANDOMIZED
CONTROL TRIAL COMPARING THE KING VISION VIDEO
LARYNGOSCOPE AND THE D BLADE OF THE CMAC VIDEO
LARYNGOSCOPE IN PATIENTS WITH C SPINE IMMOBILIZATION”
is a genuine record of research done by me under the supervision and guidance of Dr.
Sajan Philip George, Professor, Department of Anaesthesiology, Christian Medical
College, Vellore and has not previously formed the basis of award of any degree,
diploma, fellowship or other similar title of any university or institution.
Vellore Dr. Jacob Chandy
Date : September 25th 2016
6
7
8
9
10
ACKNOWLEDGEMENT
I acknowledge my dependence and gratitude to God in the successful completion of this thesis.
I express my sincere and heartfelt gratitude to Dr. Sajan Philip George, HOD and Professor, Department of Anaesthesiology, Christian Medical College, Vellore for his encouragement, meticulous support and marvelous guidance during the study.
I express my sincere and heartfelt gratitude to Dr. Melvin Alex, Assistant Professor, Department of Anesthesiology, Christian Medical College, Vellore, for his tremendous support and excellent assistance throughout the study.
I acknowledge my sincere gratitude to Dr. Raj Sahajanandan, Professor, Department of Anaesthesiology, Christian Medical College, Vellore, for his valuable advice and guidance for the conduct of this study.
I express my sincere thanks to Mr. Bijesh Yadav, Department of biostatistics, Christian medical college, Vellore for helping us through the study design and statistical analysis of this study.
I thank all my colleagues and anaesthesia technicians for their sincere and overwhelming support at all stages of this study.
I thank my family for their constant support and encouragement during this study.
I thank all the patients who consented to be part of this study without whom it would have been impossible to have this done.
11
Table of Contents
Sl. no. Contents Page No
1 Introduction 12
2 Aims and Objectives 15
3 Review of Literature 17
4 Methodology 46
5 Results 54
6 Discussion 81
7 Conclusion 88
8 Limitation 90
9 Reference 92
10 Appendix 97
12
Introduction
13
Introduction:
In patients with cervical spine injury, manipulation of the neck during endotracheal
intubation can lead to permanent spinal cord damage(1)(2). Manual inline stabilization
(MILS) is a method to minimize neck movement during intubation. Such
immobilization can render direct laryngoscopy and tracheal intubation difficult(3).
Video laryngoscopes provide better visualization of the glottis without a straight line
view as compared to the Macintosh blade(4). Therefore video laryngoscopes are more
useful in patients with cervical spine pathology in whom neck movement must be
avoided during tracheal intubation(5).
The CMAC is a non channeled video laryngoscope. The D blade of the CMAC system
was developed by Dr Volker Dorges. The primary distinguishing feature of the D
blade is its shape, which is an elliptically tapered blade rising to the distal. It claims to
provide an easy option in difficult laryngoscopies (Cormack and Lehane grade 3 and
4)(6). Complications like swelling, haemorrhage and other side effects of a difficult
intubation can be avoided.
King Vision video laryngoscope is another type of video laryngoscope with OLED
display and designed to provide minimal lifting of soft tissue and claims to minimize
trauma during endotracheal intubation(7). A channeled blade provides a port for easy
introduction of the endotracheal tube.
14
These two video laryngoscopes will be used in patients with a normal airway whose
C-spines have been immobilized by MILS to mimic an unstable cervical spine. It is
hypothesized that the King vision video laryngoscope being a channeled scope, will
reduce the time to successful intubation and thereby reduce the haemodynamic
response to intubation and associated complications such as trauma(8).
15
Aims and Objectives
16
Aims and Objectives:
1) Time for visualization of the glottis and time for successful intubation in patients
with cervical spine immobilization using the study video laryngoscope.
2) Subjective grading of the ease of intubation with the video laryngoscope using the
intubation difficulty scale (IDS), haemodyamic monitoring and associated
complications.
17
Review of literature:
18
Review of literature: Spinal cord injury is a fatal consequence of cervical spine injury from either disease or
more commonly, trauma. Of all the blunt trauma patients, cervical spine injury affects
2-5%(9) and the risk increases in patients with facial or head injury, decreased
consciousness or those with focal neurological deficits (1)(10).
Patients with a possible cervical spine injury, in the setting of trauma, would require
urgent airway intervention for various reasons such as protection of the airway,
hypoxia, hypoventilation or hypotension. Patients with known cervical spine injury or
disease may be encountered in the elective setting for either cervical spine surgery or
any other elective surgery.
Cervical spine anatomy:
The cervical spine comprises of seven vertebrae and their corresponding ligaments
and intervertebral discs [Figure 1]. The 2 upper most cervical vertebrae, the atlas and
axis (C1) (C2) respectively, support the mobility and weight of the skull (occiput).
They respectively form the atlanto-occipital and atlanto-axial joints. The cervical
spine has ligaments, which are divided into 2 columns.
The posterior column provides sturdiness during flexion and incorporates the
supraspinous ligament, interspinous ligament, and ligamentum flavum. The anterior
column furnishes sturdiness during extension and comprises of the longitudinal
ligament (posterior), the longitudinal ligament (anterior), and three ligaments that
fasten the dens (odontoid process) of C2 to the arch of the anterior part of C1. These
include the apical ligament, the occipital and the atlantal portions of the alar ligament,
19
and the transverse ligament.
These 3 ligaments restrict the translational movement between the atlas arch and the
dens to less than three millimeters. If there is damage to the transverse ligament, then
translation approaches five millimeters and if all 3 are damaged, in cases of trauma or
rheumatoid arthritis, then translation has been approximated to up to ten
millimeters(11).
Figure 1: Cervical Spine Anatomy. (a) Lateral view of the 7 cervical vertebra, pedicles
and laminae are discarded to show the spinal cord space (gray), (b) Ligaments
creating the anterior and posterior columns shown in the lateral cross section, ALL-
Anterior longitudinal ligament, PLL- Posterior longitudinal ligament, LF-
Ligamentum flavum, ISL- Interspinous ligament, SSL-Supraspinous ligament, (c)
Superior perspective of the first on second cervical vertebra and transverse ligament
(TL), which usually restricts the translation and the atlas-dens interval (ADI)
20
Cervical spine mechanics:
Usually the ligaments and bones of the cervical spine work to guard the spinal cord
from injury. The interpretation of a stable spine is, the capability of the spine to reduce
the amount of displacement under physiologic stress so as to not permit destruction or
irritation to the nerve roots or spinal cord(12). If the canal of the spinal cord becomes
narrow, spinal cord damage occurs and if this continues, then spinal cord injury
results.
At the region of C1, if the spinal canal is viewed in a sagittal plane, the anterior 1/3rd
is occupied by the dens, the middle 1/3rd is spinal cord, and the posterior 1/3rd is the
space provided for the spinal cord. This space demonstrates a buffer to guard the
spinal cord in case narrowing of the spinal canal occurs from instability of the
vertebra, subluxation of the vertebra, impingement of the disc or swelling of the spinal
cord. The canal of the spinal cord and the space provided for the spinal cord are
spaces, which are dynamic. It has a fixed volume with certain mechanisms that are
impacted by the Poisson Effect(13).
This idea imposes that if a fixed volume of a column is compressed, its CS (cross-
section) area would increase. On the other hand, if it gets stretched, its CS area would
decrease. Demonstrating the body of vertebrae as the axis during extension and
flexion, the Poisson Effect can be applied to the spinal column [Figure 2].
21
Figure 2: The Poisson Effect given to the Cervical Spine (a) During flexion of the
neck, the cervical spine axis is the body of the vertebrae, so both spinal cord and the
space provided for the cord are lengthened and tapered (gray hatch marks), (b) During
extension of the neck, both the cord of the spine and the space provided for the cord
are flattened and also widened.
During flexion of the neck, the cord of the spine and the spinal canal are stretched and
this can lead to even more reduction of the space provided for the cord by
impingement of the posterior part of the damaged intervertebral disc, or the vertebral
body, which gets subluxed. On the contrary, during extension of the neck, the length
22
of the cord and canal of the spine is reduced, which increases the CS area of each.
Initially it would appear that extending the neck and increasing the space provided for
the spinal cord would be better for the patient, but the opposite has been proven to be
true(14).
The bulge of the Ligamentum flavum, caused by laxity resulting from the decreased
height of the vertebral body has been speculated for the possible reason for extension
injury. This disadvantageous ratio of the spinal cord to the space present for the cord
is likely to be elucidated by the fact that the spinal cord is a column of almost fixed
volume and is controlled by the Poisson Effect.
As both limits of movement can be suspected in reducing the available space for the
spinal cord, it should be realized that increased flexion or extension during
management of the airway and positioning during surgery, prone position in
particular, which causes extremes of extension, can lead to compromise or more
fatally damage to the spinal cord. For this, “neutral positioning” is what is advised.
Unfortunately, there is no global definition describing neutral positioning.
Cervical spine injury types:
Health care providers treating trauma patients should be taught to have basic
knowledge of the types of cervical spine injuries and the mechanisms involved. Types
of injury are hyperextension, hyperflexion, compression, and clinically insignificant
23
injuries.
[Figure 3]
Figure 3: Cervical Spine Injury (a) Hyperflexion causing a vertebral body wedge
fracture, (b) Hyperextension causing “Jefferson” fracture of the C1 arches anteriorly
and posteriorly, (c) Hyperextension casing “Hangman’s” fracture of the pedicles of
C2, (d) Compression injuries causing vertebral body burst fractures and retropulsed
bone fragments
24
Cervical spine movement during intubation:
With the increased proximity of the structures of the airway to the cervical spine, it
has been concluded that airway intervention and positioning can cause significant
displacement of the spinal cord and the space. The sniffing position, which is used
during intubation of the trachea, involves almost full extension of the joints at the
atlanto-occiput and the atlanto-axis and flexion of the joints of the lower cervical
spine.
Every injury of the cervical spine is unique, and there is no universal standard of
measurement. Both static X-rays and dynamic fluoroscopy have been used for
measurement. But there is disagreement as to if the main focus should be on motion of
segments of 2 or 3 vertebrae versus cervical spine motion in total. These questions
have been very ambiguous, because it would be ethically incorrect to subject potential
cervical spine injury patients to a study, which is double-blinded and placebo
controlled.
One study by Hauswald et al., which used cinefluoroscopy to calculate the mean
maximum displacement of the cervical spine during manipulation of the airway in
eight human victims who had traumatic arrests within forty minutes of death showed
that mask ventilation resulted in the most displacement (2.93 millimeters), followed
by endotracheal intubation over a stylet (1.65 millimeters), oral endotracheal
intubation (1.51 millimeters), whereas, intubation through the nose resulted in least
displacement (1.20 millimeters)(15).
When Sawin et al. did a study which measured the displacement of the cervical spine
25
during endotracheal intubation in ten non trauma patients, they concluded that
insertion of the laryngoscope caused reduced movement while elevation of the blade
resulted in significant extension at every motion segment, more commonly at the
atlanto-occipital and the atlanto-axial joints, whereas endotracheal intubation resulted
in a very small degree of additional rotation(16).
Robitaille et al. used cinefluroscopy to study cervical spine movement during
intubation with direct laryngoscopy and compared it with intubation using the
Glidescope video laryngoscope when manual in line stabilization was applied to both
sets of patients respectively. They found no significant difference between the two
though glottis visualization was better with the Glidescope video laryngoscope(17).
Risk stratification for cervical spine injury:
Demetriades et al. found a relation between the Glasgow Coma Scale (GCS) and
injury to the cervical spine(1).The incidence of spinal cord injury in patients with a
GCS of 13-15 was only 1.4% whereas those patients with a GCS of 9-12 had spinal
cord injury of 6.8% and GCS ≤ 8 had 10.2%. Hackl et al. calculated odds ratios (OR)
of cervical spine injury in the presence of other clinical findings and revealed that
there is an association between severe head injury and cervical spine injury (OR 8.5),
those patients with prolonged unconsciousness (OR 14), and those with focal
neurologic deficit, (OR 58)(10). While it is important to identify patients who are at
high risk, the gold standard of care for these patients is cervical immobilization until
any injury to the cervical spine is ruled out.
26
Neck immobilization:
The neck should be immobilized in a position that is natural and neutral with the use
of manual inline stabilization (MILS), collars, hardboard with sandbags and traction
pins. Non-traumatic spinal cord diseases include ankylosing spondylitis, which require
increased padding under the head to give the patient the natural position.
Health care providers should be perfect with the various methods available for
cervical spine immobilization and the various implications involved in management of
the airway. Gold standard for immobilization of the neck is the combined use of a
hard board, a collar, sandbags, and tape or straps. This is primarily used in transfers
from the field to the hospital and can reduce the movement to approximately 5% of
range normally seen. The problem with this kind of immobilization is that it carries an
increased risk of injury by pressure and reduces the laryngoscopy view attained.
A study performed by Heath et al., found that majority of the people (64%), had
Grade three or four views with laryngoscopy when immobilized with collar-
hardboard-tape-sand bag kind of combination(18).
27
Figure 4 Neck Maneuvers During Airway Management. (a) Neck stabilization with
sandbag-collar-tape on hardboard for field care, (b) Cricoid pressure applied where
anterior ½ of the hard cervical collar is removed and the other hand rests behind the
cervical collar posteriorly, (c) Manual in-line stabilization (MILS) from the head of
the bed, with the anterior cervical collar removed and hands supporting mastoid
process and occiput, (d) Manual inline stabilization (MILS) from the bedside to allow
intervention of the airway from the head end of the bed .
28
Semi-rigid collars:
Podolsky et al. describe the hard Philadelphia collars to be better than the soft ones
but probably not as good as the combination provided by the spine board-sandbag-
tape-collar at limiting the movement in volunteers who were told to extend, flex,
rotate, bend the neck laterally while in supine(19). Bednar revealed his findings in a
cadaver model, which comprised of the anterior and posterior column. He found that
the semi-rigid collars did not limit the pathologic displacement and cervical motion
can contrarily be increased, by serving as a lever(20). In spite of these findings, and
the lack of some convenient alternative, semi-rigid collars are used and their valuable
implications for airway management should be taken seriously.
One important consideration about the hard collar is that they greatly decrease the
opening of the mouth. Goutcher calculated the average inter-incisor distance in
various volunteers as a baseline (41 millimeters) and after (26-29 millimeters) the
application of a hard collar. More than twenty percent of the participants had a mouth
opening of <= twenty millimeters (21).
Two recent studies performed on the cadaveric models further highlight the
limitations of the cervical collar placement. In the first study, Prasarn et al., showed
that even the removal and application of the cervical collar can be associated with
displacement of the cervical spine. He suggested that collars should be removed and
placed with MILS (22).
In a second cadaveric study, Horodyski et al. showed that neither one nor two piece
collars were effective in decreasing the segmental movement in the unstable or stable
29
cervical spine. There was a worse performance in the unstable cervical spine
condition(23). The current literature proves that MILS and great vigilance is required
in managing a patient with potential cervical spine injury. Cervical collar application
is only one part of the management. In addition, the demonstration of limitations of
cervical collar placement shows the need for further research in immobilization
techniques for patients with an injured cervical spine.
Manual in line stabilization:
Manual inline stabilization (MILS) is used frequently in patients with actual or
suspected cervical spine injury to reduce the risk of permanent cord injury during
intubation of the trachea(2). MILS has become the standard of care during securement
of the airway in trauma patients(24).
The main concern is that MILS makes it more difficult to visualize the cords with
conventional laryngoscopy(3)(18).This can lead to failure in intubating the trachea
and securing the airway, a cause of significant morbidity and mortality in the
operative setting(25)(26), and emergency setting(27) in spite of advancements in
airway management.
MILS makes direct laryngoscopy more difficult, because of the difficulty in aligning
the oral, pharyngeal, and laryngeal axes in order to visualize the cords when the neck
is immobilized.
As limitation in opening the mouth affects endotracheal intubation, a frequently used
practice is to remove the anterior half of the collar and have the assistant provide
MILS during intubation of the airway. This can be achieved with the assistant
30
standing by the head end of the bed or the side of the bed and using their fingers and
palms of both hands to stabilize the patient’s mastoid process and occiput so as to
gently prevent the counteracting forces to cause airway manipulation [Figure 4].
While it is a good way to avoid the problem of decreased mouth opening, MILS is far
from being perfect.
Nolan in his study found that, when compared to the sniffing position, MILS reduced
the laryngoscopic view in 45% of patients. Twenty two percent of patients had a grade
III (epiglottis only) view with MILS. Using a gum-elastic bougie increased the rate of
endotracheal intubations greatly(28). While manual inline stabilization anchors and
protects the occiput and the torso anchors and protects the lower cervical spine, it is
highly possible that forces of laryngoscopy be transferred to the mid-cervical spine.
Airway management for cervical spine injury:
Like many fields of medicine, practice criteria for airway management in patients with
probable cervical spine injury have changed dramatically over the past years. Surgical
crico-thyrotomy was specified by the Advanced Trauma Life Support guidelines in
such patients to reduce cervical spine displacement, but it was not well researched or
done always. In the late 1980s, Holley and Jordan reviewed 133 endotracheal
intubations and found that intubation through the nose was done (71%) much more
often than direct laryngoscopy with MILS (22%)(29).
In the 1990s, Rosenblatt and McCrory found that anesthetists preferred to perform
31
awake fiberoptic endotracheal intubations (60-78%) over direct laryngoscopy under
general anesthesia (32-40%)(30). Video laryngoscopes such as the Glidescope, not
introduced until around the year 2000, are widely used in combination with manual
inline stabilization or a complete hard cervical collar in order to reduce displacement
of the cervical spine in these patients.
Awake fibreoptic intubation:
Awake fiberoptic intubation is a great option for elective and semi emergent
situations. The patients have to be co-operative in this situation. It allows for
documentation of neurologic status before and after intubation of the patient.
However, the use of this technique requires significant expertise and skill and may be
complicated in situations which are emergent. Such situations include, if a patient is
too anxious to be cooperative, if a provider is not skilled in fiber optic endotracheal
intubations, or if there is blood or other secretions in the airway.
With established skill in fiberoptic laryngoscopy, correct patient selection, and
adequate anesthesia of the structures of the airway, awake fiberoptic intubation has
been shown to be a great option in many studies. In a recent study, Malcharek et al.
showed that in a group of patients at risk of secondary injury to the cervical spine,
fiberoptic intubation and patient self-positioning in the prone position after
endotracheal intubation was highly successful and feasible (31). For the anxious
patient, studies have showed that infusions of Remifentanil or Dexmedotomindine
32
may allow for a more cooperative patient during the procedure of awake fiberoptic
intubation(32)(33).
Direct laryngoscopy:
Direct laryngoscopy is technically easier to perform than fiberoptic intubation or
video laryngoscopy and, therefore, is excellent in the emergent scenario. As evidenced
by a review of around 32,000 emergency intubations by experienced anesthetists,
direct laryngoscopy was found to be safe and effective(34). When Ong et al.
compared video-laryngoscopy with fiberoptic laryngoscopy and direct laryngoscopy(
Macintosh blade), they found that direct laryngoscopy was quicker in normal airways
and similar to the other scopes in patients with difficult airway(35).
In immobilized patients, especially for emergency intubations, direct laryngoscopy
with the use of a gum elastic bougie is a good choice to convincingly secure the
airway while reducing the force applied to the cervical spine.
Laryngeal mask airway:
Laryngeal mask airways (LMAs) remain controversial for airway management in
patients with known or suspected cervical spine injury, as some studies have shown
increased cervical spine displacement in comparison to intubation and other studies
have shown no significant difference between the two(36)(37).
In addition to providing ventilation in a potentially disastrous cannot intubate, cannot
33
ventilate situation, LMAs can often be used to facilitate tracheal intubation. A study
by Arslan et al. compared different LMAs placed in patients wearing cervical
collars(38). Their findings suggest that the Airtraq single use LMA may be associated
with shorter intubation time and less damage to the mucosa in patients with an
immobilized cervical spine. The Fastrach LMA system has been validated for use in
difficult airway scenarios which includes cervical spine immobilization(39).
Joffe et al. showed how a gum elastic bougie can be used to help in placement of an
LMA Proseal without the help of an assistant(40).
This may be a valuable strategy in potential cervical spine injury without
oropharyngeal or esophageal trauma.
Regardless of the type of LMA used, they remain an essential tool in the difficult
airway algorithm for patients, including those with trauma and potential cervical spine
injury.
Video laryngoscopy:
Video laryngoscopy is an excellent option because its angulation and indirect
technique requires less force for glottic view and endotracheal tube placement. Its
narrow blade requires lesser mouth opening than most traditional laryngoscopes.
Video laryngoscopes only require alignment of the pharyngeal and laryngeal axes
which lie along much more similar angles when compared to the oral axis. This is
another reason that simplifies endotracheal intubation.
Video laryngoscopes have been introduced to clinical anesthesia to counter the
34
problem of difficult intubation. The design and optics have evolved during the last
two decades and have become part of the guidelines of the Difficult Airway society
(DAS), for the management of anticipated difficult airway. 2015 modification of DAS
guidelines have indicated to use video laryngoscope as primary airway management
plan in anticipated difficult airway rather than use them as back up plan.
Figure 5:modifications in DAS guidelines where video laryngoscopes are used as the
first option in an anticipated difficult airway scenario to optimize success on the first
attempt (The 2015 DAS guidelines).
Video laryngoscopes can either be a channeled scope or a non channeled scope. The
channeled scopes have a channel where the endotracheal tube is preloaded before
35
laryngoscopy, whereas the non channeled scopes have no such channel and hence the
endotracheal tube has to be separately introduced along the side of the scope after
glottis visualization. Examples of channeled video laryngoscopes include the Airtraq,
Airway scope and the King vision. Examples of non channeled scopes include the
Glidescope and the CMAC.
A number of studies have been done which compare video laryngoscopes with
conventional laryngoscopes as well as studies which compare channeled and non
channeled video laryngoscopes in patients with cervical spine immobilization.
Bruck et al. compared the CMAC video laryngoscope with the Glidescope in patients
with cervical spine immobilization and concluded that both the video laryngoscopes
provided excellent laryngeal visualization and that the Glidescope provided higher
first attempt success rate for endotracheal intubation.(41)
Acute angulation and less mouth opening explain how the Glidescope, when
compared with direct laryngoscopy, was used to improve laryngoscopic view and help
in successfully intubating patients wearing cervical collars. This study was performed
by Bathory et al(4).
Mcelwain and Laffey compared the CMAC and Airtraq video laryngoscopes to the
conventional Macintosh blade in patients undergoing tracheal intubation with cervical
spine immobilization with the help of manual inline stabilization. They concluded that
the Airtraq video laryngoscope provided better glottis visualization when compared to
the CMAC, which in turn performed better than the conventional scope. Intubation
difficulty scale scores were also lower in the video laryngoscope group when
36
compared to the conventional(5). Thus this study concluded that video laryngoscopes
were superior to conventional scopes in this particular setting and that the channeled
scope (Airtraq), faired better than the non channeled scope (CMAC).
Byhahn et al. compared the CMAC video laryngoscope with conventional
laryngoscopy in patients with cervical spine immobilization with the help of a rigid
collar and concluded that laryngeal view was highly enhanced in the video
laryngoscope group when compared to the conventional group(42).
Gupta et al. compared the use of the CMAC video laryngoscope with and without the
use of a stylet to aid in endotracheal tube placement in patients with cervical spine
immobilization. They showed that the use of a stylet significantly reduced intubation
difficulty scores(43).
RoyaYumul et al. compared the CMAC video laryngoscope with the flexible
fibreoptic scope for intubation in patients with cervical spine immobilization. They
concluded that the glottis view did not differ considerably at the time of intubation
between the two scopes but the time for securing the airway was much shorter with
the CMAC video laryngoscope when compared to the flexible fibreoptic scope(44).
Unfortunately, just like fiberoptic intubation, video laryngoscopes may be more
difficult to access in an urgent or emergency situation and may not provide the
expected results if the provider is not skilled with its use or there is blood in the
airway that could reduce the view provided by the camera. Even with these
limitations, some studies proclaim better success rates in the first attempt with video
laryngoscopy than direct laryngoscopy in emergency situations(45).
37
A systematic review and metaanalysis of multiple randomized control studies by
Suppan et al., comparing various alternative intubation techniques versus Macintosh
laryngoscopy, was done. 24 trials were looked into and 5 alternative intubating
devices were studies in comparison to the Macintosh blade. The 5 devices were the
Airtraq, Airwayscope (channeled), Glidescope, CMAC and the Mcgrath (non
channeled) video laryngoscopes.
The Airtraq was associated with a statistically significant reduction in the risk of
intubation failure in the first attempt. It provided a higher rate of Cormack Lehane
grade 1 laryngoscopy and a reduction in the time of successful intubation. Other
devices were associated with improved glottis visualization but no statistically
significant differences in endotracheal intubation failure or time to intubation
compared with conventional direct laryngoscopy(46).
While the use of MILS has been emphasized sufficiently in limiting cervical spine
motion during intubation, this technique has been shown to make direct laryngoscopy
much more challenging. Thus, the use of video laryngoscopy may allow in an
improved laryngeal view in the setting of MILS; although, it should be emphasized,
that cervical spine motion may be affected as much as with video laryngoscopy as
compared with direct laryngoscopy(17)(47).
Because of the relatively new technology of video laryngoscopy, large trials are still
needed to best conclude if these devices should fit in the management algorithm of a
patient with potential cervical spine injury.
38
The C-MAC video laryngoscope (Fig. 6) is a development of previous video
laryngoscopes by Karl Storz (MVL, V-MAC). It can be compared with the MVL as
described by Kaplan et al(48).It has a Macintosh steel blade shape with a blade design
which is closed. It doesn’t have any edges or gaps for hygienic traps and is available
in three sizes (2, 3, and 4).
The C-MAC blade is flattened, resulting in a slim blade profile (maximum 14
millimeters). The edges are slanted in order to avoid damage to the mouth and teeth
during laryngoscopy. Optionally, the blade can be equipped with a holder channel for
a suction catheter (14–16 Ch).
In contrast to both the MVL and V-MAC, which were based on fiberoptic technique
39
with an external light source, the C-MAC incorporates the smallest possible
(2millimeters) digital camera (Complementary Metal Oxide Semiconductor (320x240
pixels) and a high power light emitting diode, located laterally in the distal third of the
blade.
Reduced image quality due to damaged optical fibers, the need for white balance and
focusing, and immobility due to the external light source were replaced. Compared
with both the MVL and V-MAC, the embedded optical lens has an increased aperture
angle of 80° (Fig. 7). The view obtained includes the tip of the blade and, hence,
allows visual guidance of the tip of the blade into the vallecula.
A color image is displayed on a lightweight, portable high-resolution liquid crystal
display monitor with lithium ion battery technology, permitting around two working
hours without recharging. The image may also be recorded as a single picture or a
video by one touch technique either on the monitor or the video laryngoscope handle.
It can be stored using the secure digital card slot (Fig. 6).
Similar to other video laryngoscopes, a view of the epiglottis and glottis is available
on the video screen as soon as the camera section of the C-MAC enters the
pharynx(49).
40
Figure 6: The C-MAC video laryngoscope. Note the buttons for image recording on
the monitor and the laryngoscope handle. A power cord/video cable, emerging from
the handle, attaches to a dedicated, portable liquid crystal display monitor.
41
Figure 7: Main angulations of the C-MAC blade Size 3 and Size 4, respectively.
42
The D blade of the CMAC system was developed by Dr. Volker Dorges. The primary
distinguishing feature of the D blade is its shape, which is an elliptically tapered blade
rising to the distal. In comparison with the conventional C-MAC blade, which has the
Macintosh shape, the D-Blade is half-moon shaped, resulting in a higher angulation
(40 degrees). It claims to provide easy option in difficult laryngoscopies (Cormack
and Lehane grade 3 and 4)Complications like swelling, haemorrhage and other side
effects of a difficult intubation can be avoided.(Figure 8) (6)
Figure 8:A-Size 3 blade, B-Size 4 blade, C-CMAC D blade.
43
Figure 9:King vision videolaryngoscope
King vision laryngoscope is a type of video laryngoscope with OLED display and
designed to provide minimal lifting of soft tissue and minimize trauma during
intubation. A channeled blade provides port for easy introduction of ET tube.
King vision video laryngoscope is a relatively newer video laryngoscope. Tim Mullen
et al., compared the King vision with the Glidescope in cadavers with and without
cervical immobilization and found similar efficacy between the 2 scopes. He
concluded that an affordable, portable video laryngoscope such as the King vision can
play a crucial role in airway management(50).
44
King vision laryngoscope is an OLED device which was compared with the
Macintosh laryngoscope by Murphy et al and was found to decrease the time to
successful intubation in two of the four studied airway scenarios and had a higher
intubation success rate in difficult cadaver airway scenarios(7).
Jeffery et al., compared the use of the portable King vision video laryngoscopes with
direct laryngoscopy in the emergency setting, out in the field, among health care
professionals and they concluded that the King video laryngoscope improved success
of first attempt endotracheal intubations compared to direct laryngoscopy(51).
Lorenz Theiler, Kristina Hermann et al., in their multi centric prospective randomized
control trial in Switzerland are looking to compare the clinical efficacy of three
channeled video laryngoscopes versus non channeled video laryngoscopes in
simulated difficult airway patients. The channeled video laryngoscopes include
Airtraq, AP advance and King vision. The non channeled video laryngoscopes include
the CMAC, Glidescope and Mcgrath. This prospective trial will throw more light on
the efficiency of these video laryngoscopes especially the newer ones such as the King
vision(52).
Intubation difficulty score (IDS):
The IDS is a subjective description of the difficulty encountered during endotracheal
intubation. It takes into account several factors, which contribute to the difficulty
assessment. The various grades of the scoring system are easy, slightly difficult and
moderately to severe difficulty based on the summation of the subjective scores of the
seven separate questions asked(53).
45
Figure 10:
46
METHODOLOGY
47
METHODOLOGY:
Intervention and Comparator agent: randomized control study comparing 2 video
laryngoscopes, the King vision and the CMAC D blade in patients with cervical spine
immobilization.
Key Criteria
Inclusion Criteria:
1. ASA 1 and 2 patients.
2. Patients with Mallampati 1 and 2, having good neck extension.
(mentum higher than occiput on extension) and no obvious deformities such as buck
teeth, retrognathia, etc.
3. Patients coming for surgery requiring intubation.
4. Patients above 16 years and less than 70 years.
5. Patients with BMI less than 30.
Exclusion Criteria:
1.Patients who do not consent for the study.
2.Anticipated difficult airway, Mallampati 3 and 4, BMI >=30 and limitation of neck
extension.
48
3.ASA 3 and 4 patients.
4.patients at risk for aspiration (hiatus hernia).
Method of randomization:
Computer generated randomization codes were used to allot patients into the 2 groups.
Method of allocation concealment: Closed opaque envelopes.
Blinding and masking: An independent observer (not the anaesthetist on the case)
will note the time for glottis visualization and intubation, along with hemodynamic
response at 0,1,3 and 5 minutes.
Primary Outcome: Time for visualization of the glottis and time for successful
intubation.
Secondary Outcomes: Intubation difficulty score, hemodynamic response and
associated complications
Target sample size and rationale:
Tracheal intubation with a video laryngoscope in patients with cervical spine
immobilization: a randomized trial of the Airwayscope and Glidescope(8). This is a
similar study comparing a channeled and non channeled video laryngoscope. Here the
time for tracheal intubation using the Glidescope (non channeled) was 71.9 sec SD
(47.9) compared to the Airwayscope (channeled) which was 34.2 sec SD (25.1).
49
We assume the time difference between both the scopes is 25 seconds. So the
minimum number of patients to be studied is n=49.
Hence the target sample size for this study is 100,with 50 patients in each arm.
Considering the time difference between both the groups as 25 seconds, number to
treat will be 100.
Two means hypothesis testing for two means
Standard deviation in group 1 48
Standard deviation in group 2 25
Mean difference 25
Effect size 0.6849
Alpha error (%) 5
Power (1-Beta) % 90
1 or 2 sided 2
Required sample size per group 49
50
Methods in detail:
Patients coming to CMC Vellore for surgery and those requiring general anaesthesia
were recruited for surgery. Patients who did not have an anticipated difficult airway
were approached for consent for the study. A computer generated randomization put
patients in two categories. For group 1 King Vision laryngoscope was used and the
other group, CMAC D blade with a stylet was be used for intubation. A standardized
anaesthetic plan was used for all patients prior to intubation.
Patients were pre oxygenated to an ETO2 of more than 90%. Propofol was used as the
induction agent of choice (dose of 2-3mg/kg). Vecuronium (dose of 0.1mg/kg) was
used to facilitate tracheal intubation. Fentanyl was given as a bolus dose of 2mcg/kg.
Manual inline stabilization (MILS) was applied by one of the investigators in all
patients. MILS was applied from the head end of the patient after the induction of
51
anaesthesia and muscle paralysis. Based on randomization, one of the two video
laryngoscopes was used to intubate the trachea. The anaesthetist should have
performed 10 intubations on mannequins to become eligible to perform the intubation
with either device.
After ensuring adequate paralysis, the patient’s trachea was intubated by one of the
trained operators. Laryngoscopy time (time from the introduction of laryngoscope into
the patients mouth to glottis visualization), Intubation time (time from introduction of
the laryngoscope to 3 consecutive waveforms in ETCO2 or visualizing the black line
on the tube go past the cords) was recorded by an independent observer (not the
anaesthetist on the case). Intubation Difficulty scale (IDS) was graded based on the
subjective ease of intubation by the anaesthetist who intubated the patient.
Base line monitoring included heart rate, systolic blood pressure and Diastolic blood
pressure at 0 minutes. These variables were measured again at 1,3 and 5 minutes after
successful intubation.
In case of failure to intubate with the study device, external laryngeal manipulation
was used to facilitate intubation. If failed again, MILS was discontinued, head
extension was used along with external laryngeal manipulation and the patient was
intubated with the McCoy laryngoscope (rescue laryngoscope), with the help of a
senior consultant. All the data was analyzed and seen if one scope is better than the
other in potential C spine disease patients.
52
Statistical methods used to analyze data:
Data was entered using EPIDATA software. Data was screened for outliers and
extreme values using Box-Cox plot and histogram (for shape of the distribution). All
baseline variables were expressed in terms of mean ± SD if they were continuous
variables. All categorical variables were reported using frequencies and
percentages. Mann-Whitney U test was used to compare Scope with time1, time2 and
time difference. Chi-square test performed for categorical variables and the outcome
variable, scope. ANOVA was done where outcome had more than two groups.
Differences were considered significant at p<0.05. All the statistical analysis was
performed using SPSS 18.0.
53
STROBE FIGURE
54
RESULTS
55
RESULTS:
A total of 100 patients were included for the study with the ages ranging from 16-70
years. The mean age was 33 years (SD of 11.04). The maximum age of all the patients
enrolled was 64 years and the minimum age was 16 years.
Table 1: Gender distribution
Gender
Frequency
n %
Male 61 61.0
Female 39 39.0
Total 100 100.0
The gender distribution table showed a male predominance of 61% (table 1).
56
Table 2: Video laryngoscope distribution
Scope
Frequency
n %
King Vision 50 50.0
CMAC D blade 50 50.0
Total 100 100.0
Out of the 100 patients enrolled in the study, the distribution among the patients who
were intubated with King Vision video laryngoscope as compared to the CMAC D
blade were the same (table 2).
Table 3: Experience of the operator
Experience Frequency
n %
<2 years 1 1.0
2-5 years 64 64.6
>5 years 34 34.3
Total 99 100.0
Of the anaesthetists taking part in the study, 64.6% had experience of 2-5 years and
34.3% had experience of more than 5 years (Table 3).
57
Table 4: Body mass index (BMI) of the subjects
BMI
Frequency
N %
<= 25 78 83.9
> 25 15 16.1
Total 93 100.0
Majority of the subjects in the study had a BMI of less than or equal to 25 (83.9%)
and the remaining 16.1% of the subjects had a BMI of more than 25 and less than 30
(Table 4).
58
Table 5:
Time Scope Frequency(n) Mean(secs) SD(secs) P value
T1 (time to
visualize the glottis)
King vision 47 22.43 +12.65
<0.001
CMAC D 47 13.60 +10.89
T2 (time for
intubation)
King vision 47 33.21 +15.34
0.232 CMAC D 47 37.62 +19.88
T diff (T2 – T1)
King vision 47 10.78 +7.10
<0.001
CMAC D 47 24.02 +14.91
Unable to intubate 6 -
Total 100 -
On analyzing (table 5) the time to visualize the glottis (T1) between the two video
laryngoscopes, CMAC D blade had a shorter duration (13.60sec) compared to King
vision (22.43sec) p value (<0.001). The time for intubation of the airway (T2) was
similar between the two scopes while the time between visualization of glottis and
intubation of the airway (T diff) was shorter for King vision (10.78 sec) as compared
to CMAC D blade (24.02 sec) p value (<0.001).6 patients out of the total couldn’t be
intubated with the study scope and the rescue laryngoscope had to be used (Mccoy
laryngoscope).
59
Figure 11: Bar graph showing a comparison between the mean time in seconds for
visualizing the glottis (mean time 1), versus the two study video laryngoscopes
(scope).
60
Figure 12: Bar graph showing a comparison between the mean time in seconds for
intubation of the airway (mean time 2), versus the two study video laryngoscopes
(scope)
61
Figure 13: Bar graph showing a comparison between the mean time difference from
visualization of glottis and intubation of the airway in seconds (mean time_diff),
versus the two study video laryngoscopes (scope)
62
Table 6:
IDS (intubation difficulty
scale)
King vision CMAC D
n % n %
Easy(0) 26 55.3 10 21.7
Slightly difficult(1-5) 21 44.7 36 78.3
Total 47 100.0 46 100.0
P value-0.001 The subjective grading for the difficulty in intubation (IDS) was compared between
King vision and CMAC D video laryngoscopes (Table 6). In the King vision group,
55.3% of the intubations were ‘Easy’ and 44.7% were ‘Slightly difficult’.
In the CMAC D group, 21.7% of the intubations were ‘Easy’ and 78.3% were
‘Slightly difficult’.
This comparison is statistically significant (P value-0.001)
63
Figure14: Bar graph showing a comparison between the intubation difficulty scale
(IDS) and the two video laryngoscopes.
64
Table 7:
Inability to intubate
King vision CMAC D
n % n %
Yes 4 8.0 2 4.1
No 46 92.0 47 95.0
Total 50 100.0 49 100.0
P value-0.414 Out of the 50 patients in the King vision group, 8% (n=4) could not be intubated with
the study scope and required the use of the rescue laryngoscope.
Out of the 49 patients (missing data-1) in the CMAC D group, 4.1% (n=2) could not
be intubated with study scope and required the use of the rescue laryngoscope.
Table 8:
External pressure applied
King vision CMAC D
n % n %
Yes 15 31.2 30 63.8
No 33 68.8 17 36.2
Total 48 100.0 47 100.0
P value-0.001 In the King vision group, 31.2% (n=15) required external laryngeal pressure to aid in
tracheal intubation.
In the CMAC D group, 63.8% (n=30) required external laryngeal pressure to aid in
tracheal intubation. This comparison is statistically significant (P value-0.001).
65
Table 9:
Number of attempts King vision CMAC D
n % n %
1 42 85.7 45 95.7
2 7 14.3 2 4.3
Total 49 100.0 47 100.0
P value-0.092 In the King vision group, 85.7%(n=42) required 1 attempt to intubate the trachea
while 14.3%(n=7) required 2 attempts to intubate the patient.
In the CMAC D group, 95.7%(n=45) required 1 attempt to intubate the patient while
4.3%(n=2) required 2 attempts to intubate the patient.
Table 10:
Rescue laryngoscope
King vision CMAC D
n % n %
Yes 4 7.8 2 4.1
Not applicable 47 92.2 47 95.9
Total 51 100.0 49 100.0
P value-0.085 In the King vision group, 7.8%(n=4) required the use of the rescue laryngoscope
while in the CMAC D group, 4.1%(n=2) required the use of the rescue laryngoscope.
66
Table 11:
Complications Frequency(n) %
Anterior larynx 2 2
Inability to introduce scope 4 4
Superficial cut on lip 1 1
Bronchospasm 1 1
Total complication-8% The complication rate was 8%(n=8) across both the study video laryngoscopes.
67
Table 12: King Vision group:
BMI(<=25) N=40
Time 1(sec) Time 2(sec) Time diff(sec)
Mean 21.73 31.80 10.07
S.D 12.582 14.77 6.49
BMI(>25) N=4
Mean 30.25 50.75 20.50
S.D 16.21 14.72 8.42
P value 0.205 0.030 0.013
In the King vision group, the mean time to visualize the glottis(Time 1) for patients
with BMI<=25 and BMI>25 were 21.73 seconds and 30.25 seconds respectively. The
comparison is not statistically significant (p value-0.205).
Whereas the mean time for tracheal intubation (Time 2) for patients with BMI<=25
was 31.80 seconds and those patients with BMI>25 was 50.75 seconds. This
comparison is statistically significant (p value-0.030).
The mean time difference between visualization of the glottis and tracheal intubation
(Time diff) was 10.07 seconds in patients with BMI<=25 and 20.50 seconds in
patients with BMI>25.This comparison is statistically significant (p value-0.013).
68
Table 13: CMAC D group:
BMI(<=25) N= 36
Time 1(sec) Time 2(sec) Time diff(sec)
Mean 11.42 35.56 24.13
S.D 6.62 17.72 15.06
BMI(>25) N=10
Mean 21.80 46 24.20
S.D 18.46 26.31 15.80
P value 0.011 0.220 0.947
In the CMAC D group, the mean time to visualize the glottis (Time 1) for patients
with BMI<=25 and BMI>25 were 11.42 seconds and 21.80 seconds respectively. The
comparison is statistically significant (p value-0.011). The mean time for tracheal
intubation (Time 2) for patients with BMI<=25 was 35.56 seconds and those patients
with BMI>25 was 46 seconds. This comparison is not statistically significant (p
value-0.220).
The mean time difference between visualization of the glottis and tracheal intubation
(Time diff) was 24.13 seconds in patients with BMI<=25 and 24.20 seconds in
patients with BMI>25.This comparison is not statistically significant (p value-0.947).
69
Figure 15:Line graph showing the comparison between the mean time to visualize the
glottis (Mean time 1) and BMI (BMIR) between the two study video laryngoscopes.
70
Figure 16: Figure 5:Line graph showing the comparison between the mean time to
intubate the trachea (Mean time 2) and BMI (BMIR) between the two study video
laryngoscopes.
71
Figure 17: Line graph showing the comparison between the mean time difference
between visualization of glottis and tracheal intubation (Mean time _diff) and BMI
(BMIR) between the two study video laryngoscopes.
72
Table 14: King Vision:
Experience (2-5 years)
N=32
Time 1(sec) Time 2(sec) Time diff(sec)
Mean 20.56 30.31 9.75
S.D 12.37 14.94 7.04
Experience (>5 years) N=15
Mean 26.40 39.40 13.0
S.D 12.73 14.77 6.95
P value 0.174 0.046 0.108
In the King vision group, the mean time to visualize the glottis (Time 1) for
anaesthetists with 2-5 years experience and those with >5 years experience were 20.56
seconds and 26.40 seconds respectively. The comparison is not statistically significant
(p value-0.174).
The mean time for tracheal intubation (Time 2) for anaesthetists with 2-5 years
experience was 30.31 seconds and those with >5 years experience was 39.50 seconds.
This comparison is statistically significant (p value-0.046).
The mean time difference between visualization of the glottis and tracheal intubation
(Time diff) was 9.75 seconds in patients intubated by anaesthetists with 2-5 years
experience and 13 seconds in patients who were intubated by anaesthetists with >5
years experience. This comparison is not statistically significant (p value-0.108).
73
Table 15: CMAC D:
Experience (2-5 years) N=36
Time 1(sec) Time 2(sec) Time diff(sec)
Mean 11.93 35.82 23.89
S.D 6.51 16.29 15.47
Experience (>5 years) N=10
Mean 16.28 41.28 25
S.D 15.53 24.77 14.45
P value 0.88 0.56 0.45
In the CMAC D group, the mean time to visualize the glottis (Time 1) for
anaesthetists with 2-5 years experience and those with >5 years experience were 11.93
seconds and 16.28 seconds respectively. The comparison is not statistically significant
(p value-0.88).
The mean time for tracheal intubation (Time 2) for anaesthetists with 2-5 years
experience was 35.82 seconds and those with >5 years experience was 41.28 seconds.
This comparison is not statistically significant (p value-0.56).
The mean time difference between visualization of the glottis and tracheal intubation
(Time diff) was 23.89 seconds in patients intubated by anaesthetists with 2-5 years
experience and 25 seconds in patients who were intubated by anaesthetists with >5
years experience. This comparison is not statistically significant (p value-0.45).
74
Figure 18: Line graph showing the comparison between the mean time to visualize the
glottis (Mean time 1) and experience of the anaesthetist (Exp) between the two study
video laryngoscopes.
75
Figure 19: Figure 5:Line graph showing the comparison between the mean time to
intubate the trachea (Mean time 2) and experience of the anaesthetist (Exp) between
the two study video laryngoscopes.
76
Figure 20: Line graph showing the comparison between the mean time difference
between visualization of glottis and tracheal intubation (Mean time _diff) and
experience of the anaesthetist (Exp), between the two study video laryngoscopes.
77
Table 16:
King Vision:
(n=48)
HR (sec) Systolic BP(mm Hg)
0 Minute (baseline)
Mean 79.69 122.58
S.D 13.66 14.25
1 minute Mean 88.83 127.85
S.D 13.05 14.51
3 minutes Mean 82.23 115.27
S.D 11.82 15.08
5 minutes Mean 79.90 104.48
S.D 11.88 14.31
This table shows the mean heart rate and mean systolic blood pressure at baseline and
1, 3 and 5 minutes post intubation with the King vision video laryngoscope.
78
Table17:
CMAC D:
(n=47)
HR (sec) Systolic BP(mm Hg)
0 Minute (baseline)
Mean 81.47 119.09
S.D 15.02 17.10
1 minute Mean 89.21 125.60
S.D 15.60 16.15
3 minutes Mean 83.32 112.72
S.D 13.64 15.49
5 minutes Mean 80.47 104.60
S.D 12.32 12.10
This table shows the mean heart rate and mean systolic blood pressure at baseline and
1, 3 and 5 minutes post intubation with the CMAC D video laryngoscope.
79
Figure 21: Line graph comparing the mean heart rate at baseline and 1, 3 and 5
minutes post intubation with the two study video laryngoscopes.
80
Figure 22: Line graph comparing the mean systolic blood pressure at baseline and 1, 3
and 5 minutes post intubation with the two study video laryngoscopes.
81
DISCUSSION
82
DISCUSSION:
Two relatively new video laryngoscopes were used in patients with simulated cervical
spine injury using manual inline stabilization (MILS). A total of 100 patients were
recruited for the study and evenly distributed among the two study groups. The gender
distribution showed a male predominance. The majority of the study cases were
performed by the primary investigator, who had anaesthetic experience of 2-5 years.
The remaining cases were performed by anaesthetists, who had experience of more
than 5 years. Majority of the patients had BMI of less than or equal to 25.
The primary objective of the study was to analyze the time required for visualization
of the glottis and the time required for intubation of the trachea in patients with
simulated cervical spine injury using MILS. In this study we found that the time to
visualize the glottis was shorter in the CMAC D blade group (13.60 secs) as compared
to the King vision group (22.43 secs)(p value-<0.001). Liu et al. on the other hand
showed similar times for visualization of the glottis between both the channeled and
non channeled video laryngoscope groups (8). They also mentioned that the operators
performing the study had similar experience with both the scopes.
The King vision video laryngoscope is a new device in our department whereas the
CMAC video laryngoscope has been used for around 2 years prior to this study. Every
new device requires a learning curve and this is one of the reasons for the longer time
required to visualize the glottis. The King vision video laryngoscope is a channeled
scope which has a slot on the blade to mount the endotracheal tube before intubation.
This makes the scope considerably thicker than the CMAC D blade. Introduction of
83
the scope into the mouth posed an issue especially in patients whose cervical spine
was stabilized with manual inline stabilization (MILS). This is another reason why the
time for glottis visualization was prolonged when the King vision scope was used as
compared to the CMAC D blade.
The time for intubation of the airway was marginally shorter in the King vision group
(p value-0.232) but the time between visualization of glottis and intubation of the
airway was considerably shorter in the King vision group (10.78 secs) as compared to
the CMAC D blade group (24.02 secs)(p value-<0.001). The King vision video
laryngoscope, being a channeled scope, required a mere guidance of the endotracheal
tube through the glottis as compared to the CMAC D blade group where the
endotracheal tube with stylet in situ needed to be negotiated through the mouth and
guided through the glottis after removal of the stylet. Liu et al. and Laffey et al.
showed similar results in their respective studies(8)(5). They also showed a shorter
time to intubation of the airway in the channeled video laryngoscope group as
compared to the non channeled group. In our study, the time taken to intubate the
trachea was shorter in the channeled group as compared to the non channeled group
but the time difference between the groups was not statistically significant (p value-
0.232).
Anaesthetists who had performed a minimum of 10 intubations with both scopes on a
mannequin were allowed to take part in this study. Experience of the anaesthetist
based on number of years of anaesthesia exposure was also analyzed. Majority of the
84
cases were performed by the primary investigator of the study (64.6%), who had an
experience of 2-5 years.
As mentioned earlier, both the King vision video laryngoscope and the CMAC D
video laryngoscope are relatively new devices in our department. In the King vision
group, the mean time taken to intubate the airway was shorter in the experience
category of 2-5 years (30.31secs) as compared to the experience category of more
than 5 years (39.40 secs) (p value- 0.046).
As the King vision scope is a very new device in our department, it requires a learning
curve for familiarity and skill. The primary investigator performed majority of the
cases, which explains the shorter time taken to intubate the airway. On the contrary, in
the CMAC D group, the time taken to intubate the airway showed a negligible
difference (p value- 0.56) between the two experience categories, as the operators
were more familiar with the concerned scope. Liu et al., in their study have mentioned
that operators had moderate experience with both the study scopes(8).
Patients were categorized as those with a body mass index (BMI) less than or equal to
25 and those with a BMI greater than 25. In the King vision group, mean time to
intubation of the airway was shorter (31.80 secs) in those with BMI <= 25 as
compared to those with a BMI >25 (50.75 secs). The King vision scope, as seen in the
picture provided, has the viewing screen mounted on top of the handle of the scope.
This makes the whole device considerably longer as compared to the CMAC D
device. In patients with BMI more than 25, there was difficulty in introduction of the
scope due to hindrance from the anterior chest, more prominent in those with a higher
85
BMI. On the other hand there was no such problem encountered with the CMAC D
blade, which showed shorter times for both visualization of the glottis and intubation
of the airway. Thus the CMAC D blade performed better than King vision video
laryngoscope in patients with a BMI> 25.
Optimization maneuvers such as external laryngeal pressure aid in improving the
process of laryngoscopy. In our study, optimization maneuvers were applied only
when required. The frequency of usage of a maneuver was studied between both video
laryngoscope groups. In the CMAC D group, 63.8% of the patients required external
laryngeal pressure to aid in laryngoscopy as compared to only 31.2% in the King
vision group (p- 0.001). Laffey et al., also showed in their study that optimization
maneuvers were less frequently used in channeled video laryngoscopes as compared
to non channeled video laryngoscopes(5).
The intubation difficulty scale (IDS) is a subjective description of the difficulty
encountered during endotracheal intubation. It takes into account several factors,
which contribute to the difficulty assessment. The various grades of the scoring
system are ‘easy’, ‘slightly difficult’ and ‘moderately to severe difficulty’ based on
the summation of the subjective scores of the seven separate questions asked. The IDS
was compared between both the video laryngoscope groups. 78.3% of the
anaesthetists found it ‘slightly difficult’ to intubate the airway in the CMAC D group
compared to only 21.7%, who found it ‘easy’ to intubate the airway. In the King
vision group, 44.7% of the operators found it ‘slightly difficult’ as compared to 55.3%
who found it ‘easy’ to intubate the airway (p value-0.001)
86
In the King vision group, 85.7% of the patients could be intubated in the first attempt
while 14.3% required two attempts at successful intubation. In the CMAC D group,
95.7% of the patients could be intubated in the first attempt while 4.3%of patients
required two attempts for intubation. None of the patients in either group required
more than 2 attempts at intubation. 8% of the patients in the King vision group could
not be intubated with the study scope, while only 4.1% of patients in the CMAC D
group could not be intubated with the study scope. Rescue laryngoscope was used in
these circumstances with 100% success in the first attempt.
The King vision laryngoscope was found difficult to introduce into the mouth of
patients who had their cervical spines stabilized with MILS. As mentioned before, the
thickness of the channeled blade caused difficulty in introduction of the blade into the
mouth. The increased length of the scope, as it has the viewing screen mounted on top
of the handle, made it difficult to introduce into the mouth as the anterior chest
hindered the process of laryngoscopy. Once the King vision video laryngoscope was
introduced into the mouth, glottis visualization and intubation of the trachea required
less external laryngeal manipulation and was easier to perform as compared to the
CMAC D blade.
Hemodynamic response to intubation in both the groups were similar. The primary
determinant of laryngoscopic response to intubation is the time taken to intubate.
Laryngoscopic response to intubation starts at 15 seconds and reaches a peak at 45
seconds. In our study we found the mean time to intubation of the airway, similar in
both the study groups. The second determinant is the pressure on the base of the
87
tongue. Since both the devices we compared are video laryngoscopes with angled tips,
the pressure exerted may have been less than the conventional Macintosh scope. We
cannot convincingly state this, as we did not measure the pressure exerted on the
tongue.
Haemodynamic response in both Liu et al. and Laffey at al.’s study showed no
difference between the channeled and non channeled scope to laryngoscopy(8)(5).
The complication rate was 8% across both the study groups. Inability to introduce the
scope into the mouth was the highest with 4% and all the cases involved the King
vision laryngoscope. Anteriorly placed larynx was the next highest with 2% and both
the cases involved the CMAC D scope. The other complications included a superficial
cut on the lip and a case of post laryngoscopy bronchospasm, which settled with
positive pressure ventilation and salbutamol nebulization.
88
CONCLUSION
89
CONCLUSION:
1) The king vision video laryngoscope, being a channeled scope was difficult to
introduce into the mouth of the patient during laryngoscopy due to the
thickness of the blade and the cervical immobility (MILS) provided to the
patient. The CMAC D blade on the other hand, did not have such problem in
scope introduction.
2) Once introduced into the mouth of the patient, less optimization maneuvers
were required for the King vision video laryngoscope. The ease of endotracheal
intubation, as provided by the IDS scale, was better for the King vision as
compared to the CMAC D video laryngoscope.
3) The CMAC D blade performed better than the King vision video laryngoscope
in patients with a higher body mass index (>25).
4) Haemodynamic response to intubation was similar in both the video
laryngoscope groups
5) Complication rate was negligible in both the video laryngoscope groups.
6) Like any new airway equipment, the King vision video laryngoscope required a
learning curve for familiarity and skill.
90
LIMITATIONS:
1) The potential for bias exits as it is impossible to blind the operator to the video
laryngoscope.
2) The ease of intubation, as provided by the IDS, is a subjective scale.
3) The IDS was mainly constituted for direct laryngoscopy, its efficacy in indirect
laryngoscopy is less clear.
4) The King vision was relatively new in our department while the CMAC video
laryngoscope was in use for 2 years prior to the study.
5) Manual in line stabilization alone is not a foolproof method to provide cervical
spine immobilization.
91
FUTURE RESEARCH:
The efficacy of the IDS in indirect laryngoscopy can be substantialized with further
research.
92
BIBLIOGRAPHY:
1. Demetriades D, Charalambides K, Chahwan S, Hanpeter D, Alo K, Velmahos G, et al. Nonskeletal cervical spine injuries: epidemiology and diagnostic pitfalls. J Trauma. 2000 Apr;48(4):724–7.
2. Hastings RH, Kelley SD. Neurologic deterioration associated with airway management in a cervical spine-injured patient. Anesthesiology. 1993 Mar;78(3):580–3.
3. Smith CE, Pinchak AB, Sidhu TS, Radesic BP, Pinchak AC, Hagen JF. Evaluation of tracheal intubation difficulty in patients with cervical spine immobilization: fiberoptic (WuScope) versus conventional laryngoscopy. Anesthesiology. 1999 Nov;91(5):1253–9.
4. Bathory (last), Frascarolo. EvaluationoftheGlideScope for tracheal intubation in patients with cervical spine immobilisation by a semi-rigid collar. Anaesthesia. 2009;64:1337-41.
5. McElwain J, Laffey JG. Comparison of the C-MAC(R), Airtraq(R), and Macintosh laryngoscopes in patients undergoing tracheal intubation with cervical spine immobilization. Br J Anaesth. 2011 Aug 1;107(2):258–64.
6. Cavus E, Neumann T, Doerges V, Moeller T, Scharf E, Wagner K, et al. First Clinical Evaluation of the C-MAC D-Blade Videolaryngoscope During Routine and Difficult Intubation: Anesth Analg. 2011 Feb;112(2):382–5.
7. Murphy LD, Kovacs GJ, Reardon PM, Law JA. Comparison of the king vision video laryngoscope with the macintosh laryngoscope. J Emerg Med. 2014 Aug;47(2):239–46.
8. Liu EHC, Goy RWL, Tan BH, Asai T. Tracheal intubation with videolaryngoscopes in patients with cervical spine immobilization: a randomized trial of the Airway Scope(R) and the GlideScope(R). Br J Anaesth. 2009 Sep 1;103(3):446–51.
9. Crosby ET, Lui A. The adult cervical spine: implications for airway management. Can J Anaesth. 1990;37(1):77–93.
10. Hackl W, Hausberger K,. Prevalence of cervical spine injuries in patients with facial trauma. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2001;92:370-6.
11. Bouchaud-Chabot A, Lioté F. Cervical spine involvement in rheumatoid arthritis. A review. Jt Bone Spine Rev Rhum. 2002 Mar;69(2):141–54.
93
12. White AA, Johnson RM, Panjabi MM, Southwick WO. Biomechanical analysis of clinical stability in the cervical spine. Clin Orthop. 1975;(109):85–96.
13. Crosby ET. Airway management in adults after cervical spine trauma. Anesthesiology. 2006 Jun;104(6):1293–318.
14. Ching RP, Watson NA, Carter JW, Tencer AF. The effect of post-injury spinal position on canal occlusion in a cervical spine burst fracture model. Spine. 1997 Aug 1;22(15):1710–5.
15. Hauswald M, Sklar DP,. Cervical spine movement during airway management: Cinefluoroscopic appraisal in human cadavers. (Am J Emerg Med 1991;9:535-8).
16. Sawin PD, Todd MM, Traynelis VC, Farrell SB, Nader A, Sato Y, et al. Cervical spine motion with direct laryngoscopy and orotracheal intubation. An in vivo cinefluoroscopic study of subjects without cervical abnormality. Anesthesiology. 1996 Jul;85(1):26–36.
17. Robitaille A, Williams SR, Tremblay M-H, Guilbert F, Thériault M, Drolet P. Cervical Spine Motion During Tracheal Intubation with Manual In-Line Stabilization: Direct Laryngoscopy versus GlideScope® Videolaryngoscopy: Anesth Analg. 2008 Mar;106(3):935–41.
18. Heath KJ. The effect on laryngoscopy of different cervical spine immobilization techniques. Anaesthesia. 1994;49(10):843–845.
19. Podolsky S, Baraff LJ, Simon RR, Hoffman JR, Larmon B, Ablon W. Efficacy of cervical spine immobilization methods. J Trauma. 1983 Jun;23(6):461–5.
20. Bednar DA. Efficacy of orthotic immobilization of the unstable subaxial cervical spine of the elderly patient: investigation in a cadaver model. Can J Surg. 2004 Aug;47(4):251–6.
21. Goutcher CM, Lochhead V. Reduction in mouth opening with semi-rigid cervical collars. Br J Anaesth. 2005 Sep;95(3):344–8.
22. Prasarn ML, Conrad B, Del Rossi G, Horodyski M, Rechtine GR. Motion generated in the unstable cervical spine during the application and removal of cervical immobilization collars. J Trauma Acute Care Surg. 2012 Jun;72(6):1609–13.
23. Horodyski M, DiPaola CP, Conrad BP, Rechtine GR. Cervical collars are insufficient for immobilizing an unstable cervical spine injury. J Emerg Med. 2011 Nov;41(5):513–9.
24. 9781880696316 - Atls: Advanced Trauma Life Support for Doctors Student Course Manual , 8th Edition - AbeBooks [Internet]. [cited 2016 Jul 25]. Available from: http://www.abebooks.com/book-search/isbn/9781880696316/
94
25. Peterson GN, Domino KB, Caplan RA, Posner KL, Lee LA, Cheney FW. Management of the difficult airway: a closed claims analysis. Anesthesiology. 2005 Jul;103(1):33–9.
26. The American Society of Anesthesiologists Closed Claims Project :What Have We Learned, How Has It Affected Practice, and How Will It Affect Practice in the Future? | Anesthesiology | ASA Publications [Internet]. [cited 2016 Jul 30]. Available from: http://anesthesiology.pubs.asahq.org/article.aspx?articleid=1946221
27. Mort TC. Esophageal intubation with indirect clinical tests during emergency tracheal intubation: a report on patient morbidity. J Clin Anesth. 2005 Jun;17(4):255–62.
28. Nolan JP, Wilson ME. Orotracheal intubation in patients with potential cervical spine injuries. An indication for the gum elastic bougie. Anaesthesia. 1993 Jul;48(7):630–3.
29. Holley J, Jorden R. Airway management in patients with unstable cervical spine fractures. Ann Emerg Med. 1989 Nov;18(11):1237–9.
30. Rosenblatt WH, Wagner PJ, Ovassapian A, Kain ZN. Practice patterns in managing the difficult airway by anesthesiologists in the United States. Anesth Analg. 1998 Jul;87(1):153–7.
31. Malcharek MJ, Rogos B, Watzlawek S, Sorge O, Sablotzki A, Gille J, et al. Awake fiberoptic intubation and self-positioning in patients at risk of secondary cervical injury: a pilot study. J Neurosurg Anesthesiol. 2012 Jul;24(3):217–21.
32. Yeganeh N, Roshani B, Azizi B, Almasi A. Target-controlled infusion of remifentanil to provide analgesia for awake nasotracheal fiberoptic intubations in cervical trauma patients. J Trauma. 2010 Nov;69(5):1185–90.
33. Avitsian R, Lin J, Lotto M, Ebrahim Z. Dexmedetomidine and awake fiberoptic intubation for possible cervical spine myelopathy: a clinical series. J Neurosurg Anesthesiol. 2005 Apr;17(2):97–9.
34. Stephens CT, Kahntroff S. The success of emergency endotracheal intubation in trauma patients: A 10-year experience at a major adult trauma referral center. Anesth Analg 2009;109:866-72.
35. Ong J-R, Chong C-F, Chen C-C, Wang T-L, Lin C-M, Chang S-C. Comparing the performance of traditional direct laryngoscope with three indirect laryngoscopes: A prospective manikin study in normal and difficult airway scenarios. Emerg Med Australas EMA. 2011 Oct;23(5):606–14.
95
36. Keller C, Brimacombe J, Keller K. Pressures exerted against the cervical vertebrae by the standard and intubating laryngeal mask airways: a randomized, controlled, cross-over study in fresh cadavers. Anesth Analg. 1999 Nov;89(5):1296–300.
37. Kihara S, Watanabe S, Brimacombe J, Taguchi N, Yaguchi Y, Yamasaki Y. Segmental cervical spine movement with the intubating laryngeal mask during manual in-line stabilization in patients with cervical pathology undergoing cervical spine surgery. Anesth Analg. 2000 Jul;91(1):195–200.
38. Arslan ZI, Yildiz T, Baykara ZN, Solak M, Toker K. Tracheal intubation in patients with rigid collar immobilisation of the cervical spine: a comparison of Airtraq® and LMA CTrachTM devices*. Anaesthesia. 2009 Dec 1;64(12):1332–6.
39. Gerstein NS, Braude DA, Hung O, Sanders JC, Murphy MF. The Fastrach Intubating Laryngeal Mask Airway: an overview and update. Can J Anaesth J Can Anesth. 2010 Jun;57(6):588–601.
40. Galgon R, Schroeder K, Joffe A, Shepler J. Validation of the unassisted, gum-elastic bougie-guided, laryngeal mask airway-ProSealTM placement technique in anaesthetized patients. Indian J Anaesth. 2012;56(3):255.
41. Brück S, Trautner H, Wolff A, Hain J, Mols G, Pakos P, et al. Comparison of the C-MAC ® and GlideScope ® videolaryngoscopes in patients with cervical spine disorders and immobilisation. Anaesthesia. 2015 Feb;70(2):160–5.
42. Byhahn C, Iber T, Zacharowski K, Weber CF, Ruesseler M, Schalk R, et al. Tracheal intubation using the mobile C-MAC video laryngoscope or direct laryngoscopy for patients with a simulated difficult airway. Minerva Anestesiol. 2010 Aug;76(8):577–83.
43. Gupta N, Rath GP, Prabhakar H. Clinical evaluation of C-MAC videolaryngoscope with or without use of stylet for endotracheal intubation in patients with cervical spine immobilization. J Anesth. 2013 Oct;27(5):663–70.
44. Yumul R, Elvir-Lazo OL, White PF, Durra O, Ternian A, Tamman R, et al. Comparison of the C-MAC video laryngoscope to a flexible fiberoptic scope for intubation with cervical spine immobilization. J Clin Anesth. 2016 Jun;31:46–52.
45. Mosier JM, Stolz U, Chiu S, Sakles JC. Difficult airway management in the emergency department: GlideScope videolaryngoscopy compared to direct laryngoscopy. J Emerg Med. 2012 Jun;42(6):629–34.
46. Suppan L, Tramèr MR, Niquille M, Grosgurin O, Marti C. Alternative intubation techniques vs Macintosh laryngoscopy in patients with cervical spine immobilization: systematic review and meta-analysis of randomized controlled trials. Myles PS, editor. Br J Anaesth. 2016 Jan;116(1):27–36.
96
47. Aziz M. Airway Management in Neuroanesthesiology. Anesthesiol Clin. 2012 Jun;30(2):229–40.
48. Kaplan MB, Hagberg CA, Ward DS, Brambrink A, Chhibber AK, Heidegger T, et al. Comparison of direct and video-assisted views of the larynx during routine intubation. J Clin Anesth. 2006 Aug;18(5):357–62.
49. Niforopoulou P, Pantazopoulos I, Demestiha T, Koudouna E, Xanthos T. Video-laryngoscopes in the adult airway management: a topical review of the literature: Video-laryngoscopes in airway management. Acta Anaesthesiol Scand. 2010 Oct;54(9):1050–61.
50. Mullen T, Scott J. COMPARING EFFICACY OF KING VISION AND GLIDESC OPE IN CADAVERS. Br J Anae Sth 2011. 106:613–616.
51. Jarvis JL, McClure SF, Johns D. EMS Intubation Improves with King Vision Video Laryngoscopy. Prehosp Emerg Care. 2015 Oct 2;19(4):482–9.
52. Theiler L, Hermann K, Schoettker P, Savoldelli G, Urwyler N, Kleine-Brueggeney M, et al. SWIVIT-Swiss video-intubation trial evaluating video-laryngoscopes in a simulated difficult airway scenario: study protocol for a multicenter prospective randomized controlled trial in Switzerland. Trials. 2013;14(1):1.
53. Seo S-H, Lee J-G, Yu S-B, Kim D-S, Ryu S-J, Kim K-H. Predictors of difficult intubation defined by the intubation difficulty scale (IDS): predictive value of 7 airway assessment factors. Korean J Anesthesiol. 2012;63(6):491.
97
APPENDIX:
DATA SHEET A randomised control study comparing the Kings vision laryngoscope and CMAC d blade in patients with C spine immobilisation. 1.Serial no: 2.Name: 3.Hospital no: 4.Age: 5.Sex 6.Laryngoscope used 7.Time taken to visualise the glottis: 8.Time taken to intubate: 9.Experience of the operator: a.<2 years b.2-5 years c.>5years 10.Vitals 0 1 3 5 (mins) heart rate : blood pressure : 11.Number of attempts: 12.External laryngeal manipulation: Y/N 13.Inability to intubate with study scope:Y/N 14.Rescue laryngoscope success:Y/N 15.Any complication(trauma/desaturation/aspiration):
INTUBATION DIFFICULTY SCALE SCORE Serial no factors score
1 I. N1 NUMBER OF ADDITIONAL INTUBATION ATTEMPTS
additional attempts adds 1 pt
2 N2 NUMBER OF ADDITIONAL OPERATORS each additional operator adds 1 pt
98
3 N3 NUMBER OF ALTERNATIVE INTUBATION TECHNIQUES USED each add 1 pt
4 N4 LARYNGOSCOPIC VIEW AS DEFINED BY CORMACK AND LEHANE GRADE 1: N4 =0. GRADE 2: N4 =1.
GRADE 3: N4 =2. GRADE 4, N4 =3
5 N5 LIFTING FORCE APPLIED DURING LARYNGOSCOPE. N5 =0 IF INCONSIDERABLE.
N5 =1 IF CONSIDERABLE
6 N6 NEEDED TO APPLY EXTERNAL LARYNGEAL PRESSURE FOR OPTIMIZED GLOTTIC EXPOSURE. N6 =0 IF NO EXTERNAL PRESSURE OR ONLY THE SELLICK MANEUVER WAS APPLIED.
N6 =1 IF EXTERNAL LARYNGEAL PRESSURE WAS
USED
7 N7 POSITION OF THE VOCAL CORDS AT INTUBATION. N7 =0 IF ABDUCTED OR NOT VISIBLE.
N7 =1 IF ADDUCTED
Total TOTAL N1 To N7
99
PATIENT INFORMATION BROCHURE Study Title:Arandomised control study comparing the Kings vision video laryngoscope and the D blade of the CMAC video laryngoscope in patients with C spine immobilisation. WHAT IS THE STUDY? You are scheduled to undergo surgery under general anaesthesia.For giving you general anaesthesia,we need to put a tube in your wind pipe using an equipment called a laryngoscope and this procedure is called intubation.In this study we would be using a specialised laryngoscope called the video laryngoscope which provides better visualisation of the airway structures during insertion of the tube according to published literature.The CMAC video laryngoscope will be compared with Kings vision video laryngoscope during this study.Your neck will be held still during intubation and this will help us to identify which scope will be better in patients with C spine problems, at the end of the study.We would be assessing the time taken for insertion of the tube into the wind pipe and also the ease with which it is inserted.Your heart rate and blood pressure will also be monitored during the intubation procedure. IS THERE ANY DANGER BY RECRUITING MYSELF FOR THE STUDY? There is no additional danger by enrolling yourself for the study .Infact video laryngoscopes provide better visualisation of the airway structures compared to the conventional laryngoscope.Your participation in the study is entirely voluntary.You have the right to withdraw from the study at any time.If you do not wish to participate in the study,it will not affect your surgery in any way.The traditional laryngoscope will then be used as per institutional policy. IS THERE ANY EXTRA COST I HAVE TO BEAR TO BE IN THE STUDY? There are no extra charges you need to bear to be in the study.The usual charges for general anaesthesia only have to be paid. WHAT IS THE USE OF THIS STUDY? This study will help us identify which video laryngoscope is better for intubation in patients with C spine problems undergoing general anaesthesia. WILL MY NAME AND OTHER DETAILS BE KEPT CONFIDENTIAL? None of your personal details will be revealed to anyone. DO YOU DOCTORS HAVE ENOUGH EXPERIENCE IN USING THESE EQUIPMENT?
100
Yes all anaesthetists who participate in this study have undergone training in usage of these equipment. DR JACOB CHANDY DR SAJAN PHILIP GEORGE CONTACT-09894117185
101
Informed Consent form to participate in a research study Study Title:Arandomised control study comparing the Kings vision video laryngoscope and the D blade of the CMAC video laryngoscope in patients with C spine immobilisation. Study Number: ____________ Subject’s Initials: __________________ Subject’s Name: _________________________________________ Date of Birth / Age: ___________________________
(Subject) (i) I confirm that I have read and understood the information sheet dated ____________
for the above study and have had the opportunity to ask questions. [ ] (ii) I understand that my participation in the study is voluntary and that I am free to
withdraw at any time, without giving any reason, without my medical care or legal rights being affected. [ ]
(iii) I agree not to restrict the use of any data or results that arise from this study provided
such a use is only for scientific purpose(s). [ ] (iv) I agree to the use of either of the two video laryngoscopes for general anaesthesia as
per the study.[ ] (v) I agree to my neck being held still during the use of the video laryngoscope as per the
study.[ ] (vi) I agree to take part in the above study. [ ] Signature (or Thumb impression) of the Subject/Legally Acceptable Date: _____/_____/______ Signatory’s Name: _________________________________ Signature: Or
102
Representative: _________________ Date: _____/_____/______ Signatory’s Name: _________________________________ Signature of the Investigator: ________________________ Date: _____/_____/______ Study Investigator’s Name: _________________________ Signature or thumb impression of the Witness: ___________________________ Date: _____/_____/_______ Name & Address of the Witness: ______________________________
103
MASTER CHART:
SN HNO NAME AGE SEX SCOPE Time1 Time2 EXP
97.00 149002d elavarasi 31.00 2.00 1.00 #NULL! #NULL! 3.00
34.00 622812g shilapaul 16.00 2.00 1.00 20.00 25.00 3.00
50.00 601843g gurunath 16.00 1.00 1.00 14.00 19.00 3.00
19.00 452171g geetha 43.00 2.00 1.00 30.00 42.00 3.00
36.00 636833g padmakumari 23.00 2.00 1.00 #NULL! #NULL! 2.00
71.00 437544g md.showkathali 33.00 1.00 1.00 #NULL! #NULL! 2.00
24.00 520334g vijaya 32.00 2.00 1.00 40.00 44.00 2.00
69.00 401501g asitpal 36.00 1.00 1.00 24.00 36.00 2.00
75.00 481139g keerthika 17.00 2.00 1.00 22.00 34.00 2.00
47.00 632413g seema 32.00 2.00 1.00 14.00 33.00 2.00
94.00 600052g deepali 29.00 2.00 1.00 13.00 19.00 2.00
23.00 611354g devendra saw 16.00 1.00 1.00 15.00 26.00 2.00
46.00 646892g shimuchowdhury 34.00 1.00 1.00 24.00 32.00 2.00
99.00 499301g thenmozhi 31.00 2.00 1.00 18.00 27.00 2.00
92.00 495315g ananth 35.00 1.00 1.00 12.00 17.00 2.00
53.00 643995g krishnaprasad 50.00 1.00 1.00 15.00 22.00 2.00
56.00 443057g salilmira 42.00 1.00 1.00 22.00 36.00 2.00
31.00 605639g abhishekkumar 25.00 1.00 1.00 14.00 27.00 2.00
61.00 464276g munawar 22.00 1.00 1.00 11.00 18.00 2.00
79.00
vivek 20.00 1.00 1.00 24.00 32.00 2.00
74.00 600215g mahalakshmi 35.00 2.00 1.00 19.00 24.00 2.00
60.00 499555g ananth 23.00 1.00 1.00 16.00 23.00 2.00
29.00 496228g mani das 29.00 1.00 1.00 64.00 80.00 2.00
4.00 162060g mahadeb 28.00 1.00 1.00 17.00 22.00 2.00
84.00 210517g raja 19.00 1.00 1.00 29.00 34.00 2.00
41.00 493056g tapaskumar 34.00 1.00 1.00 11.00 42.00 2.00
42.00 486550g ruksana 42.00 2.00 1.00 8.00 12.00 2.00
30.00 646229g uma 37.00 2.00 1.00 16.00 24.00 2.00
86.00 229949g nishukumar 18.00 1.00 1.00 17.00 23.00 2.00
55.00 641936g sajidansari 28.00 1.00 1.00 18.00 24.00 2.00
77.00 837965f madhankumar 19.00 1.00 1.00 31.00 36.00 2.00
25.00 932933d baskar 22.00 1.00 1.00 17.00 22.00 2.00
37.00 626393g asimkumar 32.00 1.00 1.00 15.00 23.00 2.00
49.00 322798g rabindrakumar 21.00 1.00 1.00 56.00 72.00 2.00
95.00
khadija 33.00 2.00 1.00 17.00 25.00 2.00
81.00 093905g mitakidebnath 24.00 2.00 1.00 6.00 9.00 2.00
70.00 632312g khokanbiswas 46.00 1.00 1.00 16.00 22.00 2.00
45.00 646941g abdulla 38.00 1.00 1.00 11.00 30.00 3.00
6.00 250855g vanaja 61.00 2.00 1.00 15.00 20.00 3.00
11.00 246669g imrulkayes 20.00 1.00 1.00 26.00 43.00 3.00
7.00 414584g pinturatan 41.00 1.00 1.00 37.00 50.00 3.00
18.00 399837g madhumondal 27.00 1.00 1.00 36.00 42.00 3.00
13.00 444910g tumpabasu 35.00 2.00 1.00 38.00 56.00 3.00
15.00 509480a sathiya 30.00 2.00 1.00 40.00 52.00 3.00
104
90.00 472180g nimaijan 57.00 1.00 1.00 16.00 21.00 3.00
8.00 427469g tapan das 31.00 1.00 1.00 9.00 38.00 3.00
64.00 007677g ganga 32.00 2.00 1.00 #NULL! #NULL! 2.00
88.00 420156g ashihkumar 35.00 1.00 1.00 17.00 50.00 2.00
1.00
bijansaha 28.00 1.00 1.00 40.00 56.00 3.00
5.00 450278g sanjaykumar 19.00 1.00 1.00 16.00 31.00 3.00
9.00 446915g manjunath 22.00 1.00 1.00 48.00 66.00 3.00
DIA0 DIA1 DIA3 DIA5 NOA EXT ITI RS AC
#NULL! #NULL! #NULL! #NULL! #NULL! #NULL! 1.00 2.00 inability to introduce
40.00 55.00 45.00 40.00 1.00 2.00 2.00 2.00 nil
62.00 72.00 60.00 43.00 1.00 2.00 2.00 2.00 nil
80.00 90.00 78.00 64.00 2.00 1.00 2.00 2.00 nil
#NULL! #NULL! #NULL! #NULL! 2.00 #NULL! 1.00 1.00 inability to
introduce scope
#NULL! #NULL! #NULL! #NULL! #NULL! #NULL! 1.00 1.00 could not
introduce scope
80.00 72.00 70.00 68.00 2.00 2.00 2.00 2.00 nil
70.00 78.00 60.00 58.00 1.00 2.00 2.00 2.00 nil
73.00 57.00 57.00 65.00 1.00 2.00 2.00 2.00 nil
70.00 80.00 60.00 58.00 1.00 1.00 2.00 2.00 nil
87.00 78.00 78.00 87.00 1.00 2.00 2.00 2.00 nil
72.00 84.00 60.00 58.00 1.00 1.00 2.00 2.00 nil
72.00 80.00 68.00 58.00 1.00 2.00 2.00 2.00 nil
71.00 78.00 76.00 77.00 1.00 1.00 2.00 2.00 nil
78.00 74.00 68.00 62.00 1.00 2.00 2.00 2.00 nil
82.00 90.00 72.00 64.00 1.00 2.00 2.00 2.00 nil
76.00 82.00 64.00 59.00 1.00 1.00 2.00 2.00 nil
72.00 90.00 70.00 60.00 1.00 1.00 2.00 2.00 nil
70.00 72.00 62.00 67.00 1.00 2.00 2.00 2.00 nil
72.00 74.00 74.00 70.00 1.00 2.00 2.00 2.00 nil
65.00 92.00 91.00 92.00 1.00 2.00 2.00 2.00 nil
72.00 84.00 62.00 62.00 1.00 2.00 2.00 2.00 nil
80.00 90.00 90.00 80.00 1.00 2.00 2.00 2.00 nil
70.00 74.00 70.00 70.00 1.00 2.00 2.00 2.00 nil
64.00 65.00 67.00 65.00 1.00 2.00 2.00 2.00 nil
70.00 72.00 60.00 60.00 1.00 1.00 2.00 2.00 nil
72.00 84.00 78.00 58.00 1.00 1.00 2.00 2.00 nil
60.00 58.00 54.00 52.00 1.00 1.00 2.00 2.00 nil
80.00 82.00 87.00 76.00 1.00 2.00 2.00 2.00 nil
72.00 80.00 70.00 64.00 1.00 2.00 2.00 2.00 nil
72.00 82.00 65.00 50.00 1.00 2.00 2.00 2.00 nil
72.00 84.00 62.00 58.00 1.00 2.00 2.00 2.00 nil
72.00 90.00 60.00 70.00 1.00 1.00 2.00 2.00 nil
72.00 88.00 70.00 60.00 2.00 1.00 2.00 2.00 nil
78.00 78.00 78.00 56.00 1.00 2.00 2.00 2.00 nil
72.00 89.00 58.00 58.00 2.00 2.00 2.00 2.00 difficulty in intro
of scope
74.00 87.00 90.00 89.00 1.00 1.00 2.00 2.00 nil
72.00 90.00 80.00 78.00 1.00 1.00 2.00 2.00 nil
78.00 85.00 92.00 67.00 1.00 2.00 2.00 2.00 nil
105
64.00 70.00 62.00 60.00 1.00 2.00 2.00 2.00 nil
80.00 100.00 80.00 69.00 1.00 2.00 2.00 2.00 nil
78.00 84.00 82.00 60.00 1.00 2.00 2.00 2.00 lower lip
superficial cut
72.00 70.00 68.00 62.00 1.00 2.00 2.00 2.00 nil
70.00 90.00 84.00 60.00 2.00 2.00 2.00 2.00 nil
90.00 94.00 73.00 84.00 2.00 2.00 2.00 2.00 nil
96.00 98.00 76.00 62.00 1.00 2.00 2.00 2.00 nil
90.00 89.00 47.00 48.00 1.00 1.00 1.00 1.00 bronchospasm
78.00 90.00 87.00 67.00 1.00 1.00 2.00 2.00 nil
90.00 62.00 64.00 82.00 1.00 2.00 2.00 2.00 no
60.00 58.00 100.00 90.00 1.00 2.00 #NULL! 2.00 nil
80.00 80.00 76.00 72.00 1.00 2.00 2.00 2.00 nil
93.00 628143g kashinathporia 48.00 1.00 2.00 #NULL! #NULL! 2.00
26.00 484134g pabanchandra 44.00 1.00 2.00 10.00 28.00 2.00
85.00 331629g srimoti 30.00 2.00 2.00 3.00 17.00 2.00
17.00 471503g manjula 35.00 2.00 2.00 10.00 68.00 2.00
58.00 498379g sandeepsingh 28.00 1.00 2.00 14.00 54.00 2.00
38.00 488837g kalairasam 21.00 1.00 2.00 6.00 36.00 2.00
78.00 222522d soumenkabiraj 24.00 1.00 2.00 12.00 27.00 2.00
20.00 493130g rituagarwal 40.00 2.00 2.00 17.00 22.00 2.00
43.00 242311f susanta 20.00 1.00 2.00 8.00 54.00 2.00
62.00 827780b samundeshwari 35.00 2.00 2.00 8.00 38.00 2.00
51.00 620159g abhinay 46.00 1.00 2.00 11.00 24.00 2.00
44.00 081377g mdanis 44.00 1.00 2.00 15.00 53.00 2.00
68.00 339289g valsama 39.00 2.00 2.00 4.00 11.00 2.00
67.00 627404g bijankumar 39.00 1.00 2.00 15.00 30.00 2.00
63.00 766467f shib das 18.00 1.00 2.00 10.00 19.00 2.00
52.00 628285g rahulkumar 18.00 1.00 2.00 7.00 22.00 2.00
65.00 499102g sobhachowdhury 19.00 2.00 2.00 9.00 21.00 2.00
72.00 427453g sumitrasasmal 54.00 2.00 2.00 5.00 67.00 2.00
40.00 641883g jaffar 32.00 1.00 2.00 8.00 25.00 2.00
21.00 656269g pamparoy 32.00 2.00 2.00 7.00 21.00 2.00
15.00 769637d hemnath 22.00 1.00 2.00 7.00 37.00 2.00
22.00 070798c shabber 18.00 1.00 2.00 18.00 35.00 2.00
98.00 612734g ramprasad 23.00 1.00 2.00 19.00 64.00 2.00
89.00 326855b muniamal 52.00 2.00 2.00 4.00 28.00 3.00
76.00 181914g mdabdullah 19.00 1.00 2.00 7.00 17.00 3.00
3.00 415391g rajeevkumar 26.00 1.00 2.00 18.00 40.00 3.00
91.00 840299c alamelu 40.00 2.00 2.00 7.00 18.00 3.00
35.00 621523g akramhussain 64.00 1.00 2.00 6.00 36.00 3.00
27.00 478695g safiya 54.00 2.00 2.00 9.00 42.00 3.00
2.00 621566d palash das 32.00 1.00 2.00 20.00 58.00 3.00
59.00 270706f fazalullah 52.00 1.00 2.00 10.00 23.00 3.00
48.00 446739g sumanamunian 25.00 2.00 2.00 33.00 68.00 3.00
32.00
purnimaya 35.00 2.00 2.00 13.00 19.00 3.00
28.00 604005g madhusudan 29.00 1.00 2.00 17.00 35.00 3.00
33.00 482809g syedmoshiyur 35.00 1.00 2.00 12.00 25.00 3.00
106
54.00 199241f ramesh 29.00 1.00 2.00 9.00 42.00 3.00
14.00 532436d pratima 42.00 2.00 2.00 28.00 72.00 3.00
87.00 163609d dhanalakshmi 32.00 2.00 2.00 5.00 12.00 3.00
66.00 637616f smritisaha 37.00 2.00 2.00 12.00 22.00 1.00
96.00 067704f jayakanthi 34.00 2.00 2.00 14.00 52.00 2.00
82.00 474885g rikupanigrhi 37.00 2.00 2.00 19.00 27.00 2.00
80.00 631292g sumathi 33.00 2.00 2.00 35.00 55.00 2.00
57.00 635658g mohammedomar 45.00 1.00 2.00 19.00 36.00 2.00
73.00 300187g bantisingh 38.00 1.00 2.00 10.00 22.00 2.00
100.00 156204f kumar 37.00 1.00 2.00 14.00 38.00 2.00
39.00 112078g valarmathi 40.00 2.00 2.00 9.00 29.00 3.00
10.00 654386d nirmala s 31.00 2.00 2.00 70.00 103.00 3.00
12.00 452196b chanmahamadali 50.00 1.00 2.00 16.00 76.00 3.00
#NULL! #NULL! #NULL! #NULL! #NULL! #NULL! #NULL! #NULL! #NULL!
#NULL! 73.00 70.00 64.00 62.00 120.00 107.00 103.00 100.00
22.80 110.00 100.00 89.00 98.00 113.00 122.00 98.00 109.00
25.00 72.00 68.00 64.00 69.00 133.00 112.00 85.00 95.00
24.50 75.00 72.00 69.00 63.00 95.00 140.00 89.00 85.00
17.00 82.00 80.00 66.00 65.00 118.00 106.00 104.00 90.00
20.00 84.00 85.00 88.00 93.00 107.00 126.00 113.00 115.00
23.60 84.00 86.00 72.00 74.00 110.00 116.00 92.00 98.00
21.70 68.00 72.00 66.00 64.00 128.00 127.00 110.00 114.00
21.40 81.00 85.00 88.00 85.00 96.00 99.00 102.00 90.00
24.50 68.00 74.00 68.00 70.00 120.00 126.00 110.00 110.00
21.20 68.00 74.00 68.00 70.00 132.00 128.00 110.00 108.00
24.10 82.00 90.00 87.00 88.00 108.00 107.00 112.00 98.00
23.80 92.00 100.00 84.00 80.00 110.00 120.00 92.00 88.00
17.30 76.00 85.00 97.00 103.00 85.00 139.00 103.00 98.00
18.20 80.00 90.00 92.00 84.00 110.00 120.00 110.00 100.00
17.00 100.00 110.00 90.00 86.00 100.00 110.00 98.00 88.00
22.90 78.00 89.00 81.00 81.00 141.00 142.00 140.00 130.00
22.30 68.00 80.00 74.00 78.00 110.00 122.00 108.00 110.00
19.30 72.00 84.00 68.00 70.00 120.00 128.00 110.00 112.00
25.00 110.00 124.00 108.00 110.00 128.00 130.00 100.00 110.00
21.60 72.00 88.00 86.00 72.00 110.00 128.00 110.00 108.00
21.60 84.00 105.00 82.00 76.00 151.00 160.00 144.00 122.00
23.00 96.00 92.00 96.00 87.00 150.00 159.00 151.00 87.00
21.10 68.00 67.00 66.00 80.00 120.00 126.00 103.00 110.00
25.00 66.00 66.00 61.00 61.00 90.00 87.00 89.00 88.00
19.20 54.00 56.00 57.00 62.00 166.00 97.00 102.00 89.00
22.70 80.00 84.00 79.00 83.00 108.00 122.00 116.00 113.00
23.50 99.00 103.00 101.00 92.00 124.00 130.00 141.00 106.00
22.00 64.00 74.00 86.00 80.00 120.00 98.00 132.00 124.00
24.20 77.00 87.00 84.00 90.00 112.00 119.00 109.00 98.00
24.70 88.00 98.00 88.00 83.00 112.00 108.00 108.00 100.00
22.30 63.00 77.00 75.00 76.00 140.00 130.00 117.00 102.00
23.40 73.00 87.00 75.00 86.00 122.00 135.00 127.00 134.00
107
24.40 68.00 87.00 89.00 65.00 111.00 145.00 130.00 105.00
23.60 87.00 108.00 97.00 85.00 95.00 134.00 126.00 106.00
21.50 84.00 106.00 100.00 100.00 110.00 150.00 140.00 126.00
22.60 85.00 122.00 97.00 88.00 118.00 141.00 120.00 108.00
28.50 100.00 96.00 90.00 70.00 140.00 120.00 124.00 110.00
26.60 102.00 96.00 110.00 98.00 132.00 140.00 112.00 98.00
28.20 110.00 112.00 106.00 100.00 132.00 136.00 109.00 97.00
29.90 126.00 128.00 110.00 98.00 122.00 132.00 108.00 96.00
27.40 75.00 81.00 80.00 76.00 100.00 105.00 110.00 108.00
28.10 72.00 84.00 80.00 68.00 112.00 122.00 114.00 123.00
28.00 77.00 91.00 86.00 85.00 122.00 142.00 118.00 101.00
29.00 97.00 96.00 88.00 82.00 148.00 123.00 92.00 89.00
26.00 79.00 100.00 92.00 80.00 106.00 139.00 127.00 100.00
26.00 60.00 84.00 72.00 66.00 140.00 148.00 130.00 120.00
BMIR totalR time_diff HR_diff1 HR_diff1_cat
#NULL! #NULL! #NULL! #NULL! #NULL!
#NULL! 1.00 5.00 -‐3.00 2.00
#NULL! 1.00 5.00 5.00 2.00
#NULL! 2.00 12.00 16.00 1.00
1.00 #NULL! #NULL! #NULL! #NULL!
1.00 #NULL! #NULL! #NULL! #NULL!
1.00 2.00 4.00 -‐16.00 2.00
1.00 1.00 12.00 -‐6.00 2.00
1.00 1.00 12.00 -‐2.00 2.00
1.00 2.00 19.00 -‐2.00 2.00
1.00 1.00 6.00 2.00 2.00
1.00 2.00 11.00 4.00 2.00
1.00 1.00 8.00 4.00 2.00
1.00 2.00 9.00 5.00 2.00
1.00 1.00 5.00 5.00 2.00
1.00 1.00 7.00 6.00 2.00
1.00 2.00 14.00 6.00 2.00
1.00 2.00 13.00 6.00 2.00
1.00 1.00 7.00 7.00 2.00
1.00 1.00 8.00 8.00 2.00
1.00 1.00 5.00 8.00 2.00
1.00 1.00 7.00 8.00 2.00
1.00 2.00 16.00 9.00 2.00
1.00 1.00 5.00 10.00 1.00
1.00 1.00 5.00 10.00 1.00
1.00 2.00 31.00 10.00 1.00
1.00 2.00 4.00 10.00 1.00
1.00 2.00 8.00 10.00 1.00
1.00 1.00 6.00 12.00 1.00
1.00 1.00 6.00 12.00 1.00
1.00 1.00 5.00 12.00 1.00
108
1.00 1.00 5.00 12.00 1.00
1.00 2.00 8.00 14.00 1.00
1.00 2.00 16.00 16.00 1.00
1.00 1.00 8.00 18.00 1.00
1.00 2.00 3.00 26.00 1.00
1.00 2.00 6.00 30.00 1.00
1.00 2.00 19.00 -‐2.00 2.00
1.00 2.00 5.00 1.00 2.00
1.00 1.00 17.00 2.00 2.00
1.00 2.00 13.00 9.00 2.00
1.00 1.00 6.00 10.00 1.00
1.00 1.00 18.00 10.00 1.00
1.00 2.00 12.00 18.00 1.00
1.00 2.00 5.00 24.00 1.00
1.00 1.00 29.00 25.00 1.00
2.00 #NULL! #NULL! 36.00 1.00
2.00 2.00 33.00 38.00 1.00
2.00 1.00 16.00 -‐18.00 2.00
2.00 1.00 15.00 -‐6.00 2.00
2.00 1.00 18.00 20.00 1.00
#NULL! #NULL! #NULL! #NULL! #NULL!
#NULL! 2.00 18.00 -‐3.00 2.00
1.00 2.00 14.00 -‐10.00 2.00
1.00 2.00 58.00 -‐4.00 2.00
1.00 2.00 40.00 -‐3.00 2.00
1.00 1.00 30.00 -‐2.00 2.00
1.00 1.00 15.00 1.00 2.00
1.00 1.00 5.00 2.00 2.00
1.00 2.00 46.00 4.00 2.00
1.00 2.00 30.00 4.00 2.00
1.00 2.00 13.00 6.00 2.00
1.00 2.00 38.00 6.00 2.00
1.00 1.00 7.00 8.00 2.00
1.00 2.00 15.00 8.00 2.00
1.00 2.00 9.00 9.00 2.00
1.00 1.00 15.00 10.00 1.00
1.00 2.00 12.00 10.00 1.00
1.00 2.00 62.00 11.00 1.00
1.00 2.00 17.00 12.00 1.00
1.00 2.00 14.00 12.00 1.00
1.00 2.00 30.00 14.00 1.00
1.00 2.00 17.00 16.00 1.00
1.00 2.00 45.00 21.00 1.00
1.00 2.00 24.00 -‐4.00 2.00
1.00 2.00 10.00 -‐1.00 2.00
1.00 2.00 22.00 0.00 2.00
1.00 2.00 11.00 2.00 2.00
109
1.00 1.00 30.00 4.00 2.00
1.00 2.00 33.00 4.00 2.00
1.00 2.00 38.00 10.00 1.00
1.00 1.00 13.00 10.00 1.00
1.00 2.00 35.00 10.00 1.00
1.00 2.00 6.00 14.00 1.00
1.00 2.00 18.00 14.00 1.00
1.00 1.00 13.00 19.00 1.00
1.00 2.00 33.00 21.00 1.00
1.00 2.00 44.00 22.00 1.00
1.00 #NULL! 7.00 37.00 1.00
2.00 1.00 10.00 -‐4.00 2.00
2.00 2.00 38.00 -‐6.00 2.00
2.00 2.00 8.00 2.00 2.00
2.00 2.00 20.00 2.00 2.00
2.00 2.00 17.00 6.00 2.00
2.00 2.00 12.00 12.00 1.00
2.00 2.00 24.00 14.00 1.00
2.00 1.00 20.00 -‐1.00 2.00
2.00 2.00 33.00 21.00 1.00
2.00 2.00 60.00 24.00 1.00