COMPARISON OF PROSEAL LARYNGEAL MASK

AIRWAY AND ENDOTRACHEAL TUBE IN PATIENTS

UNDERGOING LAPAROSCOPIC SURGERIES

Dissertation Submitted in

Partial fulfillment of the University regulations for

MD DEGREE IN ANAESTHESIOLOGY

(BRANCH X)

(REG. NO. 201720753)

MAY 2020

GOVERNMENT THENI MEDICAL COLLEGE

THE TAMIL NADU Dr. M.G.R. MEDICAL UNIVERSITY

THENI

CERTIFICATE

This is to certify that the dissertation titled “COMPARISON OF

PROSEAL LARYNGEAL MASK AIRWAY AND ENDOTRACHEAL

TUBE IN PATIENTS UNDERGOING LAPAROSCOPIC SURGERIES”

is a Bonafide original work done by Dr.K.MAYILVANAN during May 2017 -

May 2020 in partial fulfilment of the requirements for M.D. (Anaesthesiology)

Branch X-Examination of The Tamilnadu Dr.M.G.R. Medical University to be

held in May 2020.

Prof. DR.M.BALASUBRAMANI, Prof. DR.KANNAN BOJARAAJ,

MD., DA., M.D.,D.A.,

Professor and Guide, Professor and HOD,

Department of Anaesthesiology, Department of Anaesthesiology,

Govt Theni Medical College, Govt. Theni Medical College,

Theni. Theni.

Prof. DR.K.RAJENDRAN, M.S., D.Ortho., Dean

Govt. Theni Medical College,

Theni.

DECLARATION

I Dr.K.MAYILVANAN solemnly declare that this dissertation, titled

“COMPARISON OF PROSEAL LARYNGEAL MASK AIRWAY AND

ENDOTRACHEAL TUBE IN PATIENTS UNDERGOING

LAPAROSCOPIC SURGERIES” is a Bonafide record of work done by me

in the Department of Anaesthesiology, Govt. Theni Medical College and

Hospital, Theni under the guidance of Prof. Dr.M.BALASUBRAMANI,

MD., DA., Professor of Anaesthesiology, Govt. Theni Medical College &

Hospital, Theni.

This dissertation is submitted to The Tamilnadu Dr.M.G.R. Medical

University, Chennai in partial fulfilment of the University regulations for the

award of degree of M.D. (Anaesthesiology), Branch X- examination to be held

in MAY- 2020.

Place: Theni Dr.K.MAYILVANAN

Date:

ACKNOWLEDGEMENT

With deep sense of gratitude I thank God almighty for his grace and

close presence, which strengthened and sustained me through this endeavour.

Perfection of work is possible only by the union of master brains,

expertise hands and dedicated hearts of enthusiastic people at the right time.

Thereby it gives mean immense pleasure to thank all the contributors who added

oil to the glowing lamp of my study from the time of its ignition. Their valuable

contributions reflect in the perfection of this study

I wish to express my sincere thanks to Prof. Dr. K.RAJENDRAN,

M.S., D.Ortho, Dean, Govt. Theni Medical College, Theni and the former Dean

Prof. Dr.T. THIRUNAVUKKARASU,M.D.,D.A., for granting me permission

to do my study in this esteemed institution.

I lend this opportunity to express my sincere heart full thanks and

gratitude to Prof. Dr.KANNAN BOJARAAJ,M.D., D.A., Professor and Head

of the Department of Anaesthesiology, Govt. Theni Medical College, Theni for

his motivation, constant supervision and for providing all necessary

arrangements for the conduct of the study, without which this dissertation would

not have materialized.

I would like to place on record my indebtedness to my guide

Prof. Dr.M.BALASUBRAMANI, MD., DA., Dr.M.BALAMURUGAN.,

MD., Professor of Anaesthesiology, Govt. Theni Medical College, Theni for her

constant encouragement, constructive criticism and suggestions throughout the

period of the study.

I express my profound thanks to Prof. Dr. S. VIJAYARAGAVAN,

MD,DA, Prof.Dr.S.VIJAYA,MD., for their wholehearted help and support in

doing this study.

I am extremely thankful to Dr.S.LOGANATHAN, M.D., Assistant

Professor of Anaesthesiology, Govt. Theni Medical College, Theni for his

sagacious advice and appropriate guidance to complete this study.

I thank all the Assistant Professors and Senior Residents of Department

of Anaesthesiology for their keen interest and encouragement during this study.

I thank all the Professors in the Department of Surgery, Orthopaedics,

Obstetrics and Gynaecology, Govt. Theni Medical College, Theni for theirable

help and support during the course of the study.

I also wish to thank all my colleagues for their constant help during this

study. My thanks are due to all the theatre personnel for their willing cooperation

and assistance.

I am deeply grateful to all the patients included in the study, for their

wholehearted co-operation inspite of their illness made this study possible.

I continue to be indebted to all for their support, guidance and care who

directly and indirectly involved in my progress of work and for the successful

completion of this study.

CONTENTS

S. NO CHAPTERS PAGE NO

1 INTRODUCTION 1

2 OBJECTIVES 5

3 REVIEW OF LITERATURE 6

4 MATERIALS AND METHODS 47

5 RESULTS 52

6 DISCUSSION 70

7 SUMMARY 75

8 CONCLUSION 77

9 LIMITATIONS 78

ANNEXURES

ANNEXURE I : BIBLIOGRAPHY

ANNEXURE II: MASTER CHART

ANNEXURE III:PROFORMA

ANNEXURE IV:ETHICAL

COMMITTEE APPROVAL

CERTIFICATE

ANNEXURE V:PLAGIARISM REPORT

ANNEXURE VI:PLAGIARISM REPORT

1

INTRODUCTION

Airway management is the cornerstone of anaesthetic practice, and

virtually every anaesthetic innovation in the past 25 years has had an

impact on some aspect of airway care.(1) The most important foundation of

quality anesthetic practice is safe and effective airway management and the

laryngeal mask airway (LMA) is one of the keystones of modern anesthetic

practice(2). In addition to maintaining a clear patent airway to facilitate the

administration and maintenance of anesthetic agents, it is the role of the

anasthesiologist to ensure adequate maintenance of oxygenation of the

lungs. In the race towards airway maintenance, several devices and

methods with modifications were tried and tested since time immemorial.

However, the search for a quick, safe and a convenient method is still on

and an ideal device or method is yet to be identified.

The endotracheal tube is an amalgam of the ideas and innovations of

physicians across multiple centuries, having gone through multiple

iterations before arriving at its current form.(3) For a very long time, the

gold standard among airway devices has been the endotracheal tube (ETT).

However, considerable morbidities ranging from minor side effects such

as sore throat to more serious complications such as autonomic stimulation

and difficult or failed intubation are seen with laryngoscopy and

endotracheal intubation.(4) Further several hemodynamic changes are seen

2

following endotracheal intubation(5) and to avert this, an increased use of

alternatives like light wand, supraglottic devices and fibre optic scopes

have become a routine in anesthetic practice.

Supraglottic airways (SGAs) offer distinct advantages including an

increased speed and ease of placement, maintenance of haemodynamic

stability during induction and emergence. LMA which is a Supraglottic

device has the advantage of being inserted blindly through the mouth and

into the hypopharynx, forming a seal around the glottic opening allowing

for ventilation.(6)

LMAs are single-use or reusable airway devices which may be used

as an immediate life-saving measure in a difficult or failed airway or as a

method to maintain an open airway during the administration of anesthesia

temporarily as outlined in the difficult airway algorithm published by many

societies of anesthesiology worldwide. Introduced into clinical practice as

early as the 1980s, they were used predominantly in the operating room but

of late have become widely used in the intensive care unit, emergency

department and field settings. In comparison to bag-valve mask, LMAs

are easier to use and more effective especially in the hands of basic life

support providers and may be used as an alternative to intubation by

advanced life support providers. A safe and effective method of securing

an airway in anesthesia and critical care settings is provided by LMA. For

these reasons, the Australian resuscitation council and The American

3

Society of Anaesthesiologists have endorsed the LMA as rescue airway,

and as a first line airway management device in those with limited airway

management experience.(7)

The classical laryngeal mask airway (cLMA), first described in

1983, fills the gap between the face mask and tracheal tube by achieving

precise anatomical position and greater degree of invasiveness. It has

gained widespread acceptance as a general-purpose airway for routine

anaesthesia, and with the development of the reinforced LMA, a number

of specialized uses have emerged. The safety and efficacy of the device for

spontaneous and controlled ventilation during routine use has been

confirmed by published data from large studies.(8) The hemodynamic

response following insertion of Laryngeal Mask Airway (LMA) is

considerably less when compared to laryngoscopy.

Several modifications, additions, and variations of LMA have been

developed and are currently in use despite the classic LMA providing an

airtight seal over the glottic opening to provide effective gas exchange.(9)

Designed and introduced in 2000 by Dr. Archie Brain, the ProSeal™

laryngeal mask airway (PLMA; Intavent Orthofix, Maidenhead, UK), is

based on the classic laryngeal mask airway (cLMA).(10) Several

modifications were designed to enable separation of the gastrointestinal

and respiratory tracts, diagnose mask misplacement, enable controlled

ventilation and improve the airway seal. A drain tube (DT) aims to reduce

4

risks of gastric inflation, regurgitation and aspiration of gastric contents

and also enables diagnosis of mask misplacement.(11)

A randomized controlled study would be ideal to identify the various

hemodynamic changes associated with ETT and Proseal LMA. With the

aforesaid background information this study is intended to study the

various advantages of Proseal Laryngeal Mask Airway as opposed to Endo

Tracheal Intubation for subjects undergoing general anesthesia for various

laparoscopic surgical procedures in a Tertiary Care Setting.

5

OBJECTIVES

1. To compare the Hemodynamic parameters during Proseal LMA

insertion with ETT insertion

2. To compare the ease of Proseal LMA insertion with ETT based

on number of attempts, duration of insertion

3. To compare the ease of Ryle’s tube insertion while using

PLMA and ETT based on attempts at insertion and timing of

insertion

4. To find out the incidence of post-operative side effects

assocuiated while using PLMA and ETT

6

REVIEW OF LITERATURE

Anaesthesiology a branch of medical sciences has a wide scope of

services which ranges from perioperative patient care to critical care,

trauma care, pain management and palliative care. Anaesthesiology has

developed into a major speciality. In the last 150 years and its rate of

advance has seen tremendous shifts comparing to most other branches of

medicine. There has been increased understanding of drug delivery,

physiology and monitoring. It has made even the most difficult surgical

and diagnostic procedures possible to undertake, which were considered

impossible earlier Anaesthesiologists play a predominant role during

surgery by maintaining the anaesthetic state of the patient during surgery

and help in recovering from anaesthesia after surgery.(12) Providing good

anaesthesia is like an art, which is better practiced than learnt and is

enjoyed by the patients from the time of their induction to recovery. With

the invent of anaesthesiology, the complicated surgeries and diagnostic

procedures have become an easy task. Anaesthesiology has become special

advanced branch of medicine, which includes labour analgesia, patient

controlled analgesia, Bispectral Index (BIS) monitors, fibre optics,

simulators and robotic surgeries.(13)

7

It is estimated that each year in the United States nearly 40 million

anesthetics are administered for surgical and other procedures. More than

90 percent of these anesthetics involve Anesthesiologists. In the operating

room, anaesthesiologists are responsible for the medical management and

anesthetic care of the patient throughout the duration of the surgery. The

anesthesiologist must carefully match the anesthetic needs of each patient

to that patient’s medical condition, responses to anesthesia and the

requirements of the surgery.(14)

As anaesthesiologists are entrusted with patient safety during

administration of anaesthetic agents during general anesthesia,

management of airway becomes a prime importance to the

anesthesiologist. Since time immemorial several devices have been tried

for airway maintenance and delivery of anesthetic agents. The discovery

of endotracheal intubation was the most important milestone in the field of

anaesthesia and it is usually done by using direct laryngoscopy under direct

vision.(15) However, it has disadvantages of triggering hemodynamic

changes and reflexes which can at times be dangerous to selected groups

of patients.(16,17)

Anaesthesia units dispense a mixture of gases and vapors and vary

the proportions to control a patient’s level of consciousness and/or

analgesia during surgical procedures. An anesthesia system comprises

platform for delivery of gas, a system for distribution including analysis,

8

and several monitors which are optional in most units. Several

cardiopulmonary function and/or gas and agent concentrations in breathed-

gas mixtures are indicated by levels and variations of several physiologic

variables.

UPPER AIRWAYS – Structure and Function(18)

Anatomically the passage through which the air passes in and out of

lungs during respiration is called airway which may be divided into upper

and lower airway.

The upper airway comprises of

Nasal cavity

Oral cavity

Nasopharynx

Oropharynx

Pharynx

Larynx.

The lower airway comprises of

Trachea

Bronchi

Bronchioles

Alveoli

9

Figure 1 : ORAL CAVITY

MOUTH:

It extends from mouth opening bounded by the upper and lower lips

up to anterior tonsillar pillars. Cheeks are made up of muscles, buccal pad

of fat and the parotid gland. The floor of mouth has soft tissue, muscles,

tongue and has opening of submandibular glands. The mouth cavity is

formed by maxilla, mandible and teeth in front, above by hard palate and

soft palate, below by anterior 2/3 of tongue. An ability to maintain good

mouth opening is more important for effective airway management.

10

Figure 2 : EXTERNAL NOSE

NOSTRILS:

It has a free tip and a root at its junction with the forehead. The lateral

margins of the nostril are called alae nasi. The framework of the nose is

formed by bones and cartilages. The upper part is supported by a pair of

nasal bones, frontal process of maxillary bone and nasal part of frontal bone

and the lower part is formed by upper and lower nasal cartilages with

contributions from septal cartilages. In estimating the length of airway

devices, the distances from alae nasi to various points on the external ears

are used.

11

Figure 3 : LATERAL VIEW OF NASAL, ORAL PHARYNX AND

LARYNX

NASAL CAVITY:

The inside of the nasal cavity presents an irregular surface and is

usually triangular in cross section. The nasal septum which is made up of

bony and cartilaginous parts separates the nasal cavity into right and left

halves. The nasal cavity which is the narrowest part of the upper airway,

extends from anterior nares to nasopharynx posteriorly. The roof of the

cavity is formed by the cribriform plate of ethmoid and the floor by the

palatine process of maxilla and palatine bone. The lateral wall is irregular

12

due to presence of 3 turbinates and it houses the openings of paranasal

sinuses. The important function of the nasal cavity is warming and

humidification of air as it passes through the nose.

PHARYNX:

The pharynx is a fibro muscular structure which extends from the

base of the skull up to the level of the 6th cervical vertebra or cricoid

cartilage. It becomes continuous with the oesophagus and larynx.

The pharynx is divided into

Nasopharynx

Oropharynx

Laryngopharynx

NASOPHARYNX:

It is a continuation of the nasal cavity and extends from the base of

skull to the soft and hard palate below. It communicates with nasopharynx

through the posterior nares or choana. It consists of the nasal cavity,

septum, posterior end of turbinates, adenoids and the eustachian tube

openings. It bounded posteriorly by the body of C1 and C2 vertebrae.

OROPHARYNX:

Oropharynx extends from hard and soft palate above to hyoid bone

below and is bounded below by the base of tongue up to the epiglottis. It

13

includes the tonsils, uvula and epiglottis. The vallecula is the space

between epiglottis and the base of the tongue and has paired depressions

on two sides of the median glossoepiglottic fold. The tip of laryngoscope

blade lies in vallecula during classical laryngoscopy. The elevation of

larynx upward produced by pressure using laryngoscopy blade helps to

align the pharyngeal and laryngeal axes thereby enabling direct

visualization of the laryngeal inlet.

LARYNX:

It extends from the laryngeal inlet to the lower border of cricoid

cartilage. It protects the lower airway as an inlet valve from the contents of

the Gastro Intestinal Tract during the act of deglutition and also acts as an

organ of voice. It lies at level of C3 to C6 body of vertebrae. It moves

vertically and anteroposteriorly during swallowing and phonation. Larynx

includes cartilages which are paired and unpaired. Three unpaired

cartilages include the thyroid, cricoid, and epiglottis while the paired

cartilages include the arytenoids, corniculates and cuneiforms.

14

Figure 4 : LARYNGEAL CARTILAGES

The epiglottis is leaf like cartilage which has a broad free upper

margin. Its lower end is attached to the angle between the inner aspects of

laminae of the thyroid cartilage. The epiglottis is connected to the base of

the tongue by a median glossoepiglottic fold and 2 lateral glossoepiglottic

folds.

The thyroid cartilage is the largest of the laryngeal cartilages. It is

shaped like a “v” and is made up of 2 quadrilateral laminae. In male, the

line of junction formed by 2 laminae is acute and it raises a projection on

the outside called ‘Adams apple’. Vocal cords are attached to the inner

aspect of the laminae of thyroid cartilage.

15

The cricoid is the laryngeal cartilage which forms a complete ring

and resembles a signet shaped ring. The cricoid forms the narrowest part

of the airway especially in children placing it at a high risk for impaction

of foreign bodies. A membrane which extends from cricoid cartilage to the

thyroid cartilage anteriorly is known as the cricothyroid ligament. The

upper free border of this conus elasticus membrane forms the vocal cord.

Arytenoids are pyramidal shaped paired cartilages. The apex of the

arytenoids articulates with corniculate and cuneiform cartilage. Vocal cord

are attached to the vocal process of the arytenoids cartilage and movements

of these cartilages are responsible for adduction and abduction of vocal

cords. Corniculates lies at the apex of arytenoids. Cuneiforms are rods

shaped and it is situated in front of corniculate.

16

Figure 5 : LARYNGEAL CARTILAGES

Figure 6 : VOCAL CORD

17

History of Endotracheal Intubation

In the beginning, there were only blind or tactile techniques like

indirect laryngoscopy to visualize the larynx. The Spanish singing

instructor Manuel Garcia (1805-1868) introduced this concept through his

paper titled “Observations on the Human Voice,” wherein he described the

visualization of active vocal cords during vocalization. He managed to

view the vocal cords by placing small mirrors at the end of instruments that

provided specific angles.(19)

The first to perform an endotracheal intubation was probably the

eminent Belgian anatomist, Andreas Vesalius in 1543 (Vesalius, 1543).

Andrea Vesalius is to be regarded as the inceptor of endotracheal

anaesthesia, even though the full significance of his classical experiment

did not become apparent for many years. He inserted a tube of reed or cane

into the trachea after performing a preliminary tracheostomy on a pig,

opened the thorax and then applied artificial ventilation by blowing down

the tube. One of the most advanced and skillful manoeuvre, its value as a

means of maintaining pulmonary ventilation after thoracotomy was fully

appreciated only centuries later(20)

The person credited with the first description of anesthesia

administered via an endotracheal tube is William Macewen, a surgeon in

Glasgow Glasgow following his idea of removing a malignant tumour from

base of tongue of a patient. Macewen realized the importance of

18

endotracheal tubes to protect the airway from blood and surgical debris

which was accomplished by placing a pharyngeal pack around the tube

instead of an inflatable cuff for oral and upper airway surgery.(21) In

addition, he noted as the surgeon and anesthetist did not compete for access

to the mouth and airway, he noted the additional benefit of uninterrupted

surgery that endotracheal anesthesia allowed. He preferred the nasal route

for intubation using metal tubes.

Figure 7 : Pugh’s air pipe

However, performing endotracheal intubations did not become

common practice until blind nasotracheal intubations was introduced

during the First World War by Dr Ivan Magill. Today, endotracheal

intubations have become routine in the anesthesia and critical care settings.

Indeed, an ETT is the most effective and safe method of securing an

airway. Benjamin Pugh, a Chelmsford surgeon performed endotracheal

intubation for resuscitation, in 1754, by using an "air pipe" (fig. 7) made

from a coiled wire covered with soft leather. A tactile technique was used

19

to insert the "air pipe" orally into the trachea of an asphyxiated neonate.

The anesthesiologist then blew down the tube intermittently. Although the

introduction of the pipe was difficult and usually traumatic, it proved to be

an effective method. (20,22)

Endotracheal intubation is known to induce several hemodynamic

changes like reflex cardiovascular responses such as increase in heart rate,

arrhythmias, increase in blood pressure, myocardial ischemia, infarction

besides hypoxia, hypercapnia, bronchospasm, laryngospasm and rarely

causes rise in intracranial pressure and intraocular pressure.(23–25)

However, the realization that other less invasive devices can be used

in a wide number of situations prompted a search for a suitable alternative.

For the device to be less invasive at the same time being able to make gas

exchange effective by providing an airtight seal, it should be supraglottic

in nature.(22) The most important and widely used supraglottic device today

is the laryngeal mask airway (LMA)(9)

20

Table 1: CLASSIFICATION OF SUPRAGLOTTIC DEVICES(26-28)

First generation devices Second generation devices

Simple airway tubes Airway tubes with addition of drainage

tubes

Classical Laryngeal Mask

Airway (cLMA)

Flexible LMA

Unique LMA

Cobra Perilaryngeal LMA

Proseal LMA

I-GEL, Laryngeal Tube

LMA Supreme

Streamlined Liner of the Pharyngeal

Airway

1. The Laryngeal Mask Airway Family

LMA Classic

LMA Unique

LMA Flexible

LMA Fastrach

LMA Ctrach

LMA Proseal

2. Other supraglottic airways similar to Laryngeal Mask

Soft Seal Laryngeal Mask

Ambu Laryngeal Mask

Intubating Laryngeal Airway

21

3. Other supraglottic airway devices

Laryngeal Tube Airway

Perilaryngeal Airway

Streamlined Pharynx Airway Liner

BASED ON GENERATION

Table 2: Features of first and second generation supraglottic devices

First Generation Second Generation

Simple airway

Low pressure pharyngeal seal

May or may not protect from

aspiration

Have no specific design to

lessen the risk

Examples

CLMA

Flexible LMA

Laryngeal Tube

Cobra Perilaryngeal Airway

Specially designed for safety

High pressure pharyngeal seal

Reduce the risk of aspiration

May be more efficacious in

ventilation

Examples

PLMA

Supreme LMA

Gel

SLIPA

22

BASED SEALING MECHANISM

Table 3: Classification of supraglottic devices based on sealing

mechanism

Cuffed peri-laryngeal

sealer

Cuffed pharyngeal

sealer

Cuff-less preshaped

sealer

Non directional non

esophageal sealers -

CLMA, Flexible

LMA, Unique LMA

Directional non-

esophageal sealing -

Fastrach

LMA,ALMA.

Directional esophageal

sealing -

PROSEAL,Supreme

LMA.

Without

esophageal sealing

-COPA,PAX

With esophageal

sealing -

Combitube,

LT,LTS

With esophageal

sealing – BASKA,

I –Gel,

Without

esophageal sealing

- SLIPA, AIRQ

23

BASED ON NO OF LUMEN

Single lumen devices - CLMA, Flexible, Unique, ILMA, Ambu,

Cobra, SLIPA, Laryngeal Tube

Double lumen devices - Proseal LMA, Combitube, Airway

Management Device

Triple lumen devices - Elisha Airway Device

FEATURES OF AN IDEAL SAD:

During both spontaneous and positive pressure ventilation, an

efficient seal of the upper airway is a must

There should be low resistance to gas flow

Should protect airway from upper airway secretions and contents of

GIT

SUPRA GLOTTIC AIRWAYS

1st Generation

Airway tube only

Additional design features to reduce the

risk of aspiration

2nd Generation

Higher seal pressures to enable controlled

ventillation at higher airway pressure

Integral bite block to protect the patients

airway against occlusion

24

The incidence of airway morbidity and adverse events should be low

It should be easily accepted by the oropharynx in terms of shape,

material, cuff volume and cuff position

Basic design and features of Laryngeal Mask airway

In the operative setting in pre-selected patients on fasting, LMAs

may be used as a primary airway management device. LMAs are used as a

temporary bridge to intubation especially by pre-hospital providers in the

emergency setting, in cardiac arrest situations, as a rescue device in

difficult airway situations and in a failed airway situation as a means to

attempt ventilation followed by either intubation through the device or

while a surgical airway is performed.(5,29,30)

Though LMAs are excellent alternatives when compared to bag

masks in reducing the risk of gastric inflation thereby decreasing the risk

of aspiration, they are far less protective than an endotracheal tube. LMAs

are an effective method of ventilation and should be utilized unless it is

ineffective in patients requiring prolonged mask ventilation.LMAs have

been used successfully in pediatric patients, adults, and the obese.

In the development of airway devices over the past 20 years, LMA

is the most important. It is designed for airway management of cases with

spontaneous ventilation and has been listed in five different places in the

25

ASA difficult airway algorithm as an airway or a conduit for ETT

intubation.

Dr Archie Brain, an anesthesiologist from the United Kingdom is

the inventor of the LMA. Though the development on the LMA started as

early as 1981, it was available for commercial use, in the United States

only by 1992. Since its introduction, several modifications, additions, and

variations have been developed, and are currently in use(9).

Types of LMA

Classic LMA

Figure 8 : Classical Laryngeal Mask Airway

The classic LMA consists of a flexible tube called airway tube which

is provided with 15 mm male adaptor and with an inflatable mask. The

mask is a flattened, pearshaped with an open front. The mask is bordered

26

by an oval, inflatable, cuff made up of silicone is designed to seal around

the laryngeal inlet. If properly positioned, the opening overlies the glottis

and the proximal end opposes the base of the tongue and the distal rim

wedges against the upper esophageal sphincter, making a seal. The classic

LMA is autoclavable and reusable. There are two plastic bars at distal

opening of the cuff called aperture bars whose role is to prevent obstruction

by epiglottis. An inflation tube and self-sealing pilot balloon are present at

the proximal end of the tube. LMA is sterilized by stream autoclaving and

is reusable 40 times. The intracuff pressure recommended for LMA

maximum level is less than 60 mm H2O which is the perfusion pressure of

the pharyngeal mucosa. Pressures above this level produce is known to

produce pharyngeal mucosal injury and increase the incidence of sore

throat.

Proseal LMA

The ProSeal LMA is a modified version of the classic LMA and was

released in the year 2000. The distal tip has an esophageal drainage port

designed to communicate with the gastrointestinal tract In addition to the

silicone rim intended to obtain a seal around the larynx,. The port permits

suctioning, potentially decreasing the risk of gastric content aspiration(10).

The LMA is available currently in eight sizes(28)

27

Table 4: Various sizes of LMA

LMA size Weight of patient

Maximum cuff

inflation volume

(mL)

1

1.5

2

2.5

3

4

5

6

Neonates/infants upto 5 kg

Infant between 5 and 10 kg

Infants / children between 10 and 20 kg

Children between 20 and 30 kg

Children 30 to 50 kg

Adults 50 to 70 kg

Adults 70 to 100 kg

Adult over 100 kg

4

7

10

14

20

30

40

50

ADVANTAGES OF LMA:

Lower hemodynamic instability due to less stimulation of sympathetic

system

Avoidance of laryngoscopy and muscle relaxants

The patient tolerates it even under light plane of anaesthesia

Ease of insertion and smooth recovery

Used as a life saving device in securing airway in cases of “cannot

ventilate, cannot intubate situations”

Displacement of bacterial colonies from oral or nasal to lower

respiratory tract is minimal

Lesser chances of injury to airway compared to ETT

Pollution to operating room is less compared to face mask.

Recovery and emergence time is less

28

DISADVANTAGES AND CONTRINDICATION OF LMA:

It is not a definite airway

It does not provide protection against aspiration so contraindicated in

full stomach patient

Not useful in patient with glottis and supraglottic obstruction, or

pathology

Not recommended for patients with poor lung compliance as it needs

high inflation pressure

Patients with restricted mouth opening

Oral and cervical pathologies like large goitre, tumour.

INDICATIONS OF LMA: (31,32)

Elective surgeries like short elective surgical procedure as an alternative

to ETT intubation.

Anticipated and unanticipated difficult airway

In situation like cannot ventilate and cannot intubate

In cardiac arrest – during CPR as an alternative to ETT intubation

Used as conduit for ETT insertion when difficult intubation occur

Useful in radiation therapy, diagnostic and interventional radiology,

ECT, endoscopy

As a bridge to extubation

29

Ophthalmic, neurosurgery, unstable cervical spine, supplementing

regional block – useful in above procedures

COMPLICATION OF LMA:

Aspiration of gastric contents

Gastric distension

Complete or partial airway obstruction

Traumatic injuries to the tongue, soft palate, uvula, tonsils, epiglottis

and pharyngeal mucosa.

Dislodgement occurs accidentally when not in proper position, cuff is

overinflated or inappropriate size is used

Damage to LMA, failure to inflate or deflate can occur

Bronchospasm, dysphagia and nerve injury may occur during LMA

use

PROSEAL LMA(26)

Proseal Laryngeal mask airway was developed and introduced by

Dr. Archie brain in year of 2000. It was developed in order to prevent

aspiration and for effective positive pressure ventilation.

DESCRIPTION OF PROSEAL LMA:

It has following parts mask, airway tube, pilot balloon with inflation

line, drain tube. It is made up of silicone and is reusable. All components

are latex free. There are 6 sizes available now.

30

Table 5: Features of various sizes of proseal LMA

LMA Proseal

LMA

Size

Patient

weight

(Kg)

Maximum

cuff

inflation

volume

(ml)

Maximum

gastric

tube size

(French)

Maximum

fiberoptic

scope size

(mm)

Length

of drain

tube

(cm)

Largest

tracheal tube

(ID in mm)

1.5

2

2.5

3

4

5

5 – 10

10 – 20

20 –30

30 – 50

50 – 70

70 - 100

7

10

14

20

30

40

10

10

14

16

16

18

-

-

-

-

4

5

18.2

19.0

23.0

26.5

27.5

28.5

4.0 uncuffed

4.0 uncuffed

4.5 uncuffed

5.0 uncuffed

5.0 uncuffed

6.0 cuffed

Table 6: Maximum cuff dimensions of proseal LMA

Maximum cuff dimensions(33)

Mask size Air

volume

Maximum

bulge of

cuff

tip (mm)

Maximum

bulge of

wide end of

cuff (mm)

Maximum

transverse

diameter of

cuff (mm)

1

1.5

2

2.5

3

4

5

6

10

15

21

30

45

60

7.8

9.5

11.5

13.0

14.8

17.0

21.1

8.6

10.2

13.0

14.5

16.6

19.0

22.4

26.3

32.6

39.0

45.0

51.2

58.5

68.3

31

The cuff is intended to fit to the anatomy of the perilaryngeal

structures, with its lumen in front of the laryngeal opening. It has a large

ventral cuff that is attached to a second rear cuff which is attached to the

dorsal surface of the mask. This rear cuff helps to improve seal around

periglottic tissue. This rear cuff arrangement makes the proseal LMA

withstand higher seal pressure of 35 cm H2O. Airway tube is short and

smaller than classic LMA. The airway tube is reinforced with wire which

makes it flexible and prevents collapse. Its end is connected to a 15 mm

connector. Distal end of tube has an insertion slot for the introducer tool.

The PLMA bowl is deeper and does not have aperture bars. The

drainage tube traverses the cuff to open distally which is parallel and lateral

to airway tube. This facilitates passing gastric tube, Doppler probe,

thermometer and stethoscope into the oesophagus. This tube is intended to

divert regurgitated fluids and prevent gastric insufflations.

The position of the tube within the bowl is designed in such a way

to prevent the epiglottis occluding the airway tube, as a result of which the

aperture bar is not required. This reduces the resistance to gas flow. The

double tube design has an important role to provide greater stability to the

device after insertion. To protect the tube against the patient from biting, a

built in bite block is present in proximal end of the tubes. It prevents

obstruction to airway tube and also provides information about depth of

insertion. It helps to fuse airway and drainage tube together.

32

A malleable reusable introducer is available in order to facilitate

placement of proseal LMA. It is a curved blade with guiding handle. The

distal end fits into introducer strap and the proximal end clips into the

tubes. PLMA is reusable up to forty times. This should be discarded if it

fails the pre check test. A rectangular depression of the proximal bowel

tube act as an accessory ventilation port and prevents pooling of secretions

at distal airway opening.

PRE – PLACEMENT TEST:

Visual inspection:

Examine the transparency of the airway tube. A discoloured tube

impairs the ability to see foreign particles or regurgitated fluids. Examine

the device for any external or internal damage. Flex the tube up to but not

beyond 180 degree at the junction of the LMA cuff to the shaft. The tube

is not to be used if it kinks at this degree.

Inflation and deflation:

The cuff is fully deflated with syringe so that its wall approximates

against each other. Discard the device if it re-inflates. Next, inflate the cuff

with air and see for any air leakages or any irregular shape. If any changes

are present discard the device.

33

Care and cleaning: (34,35)

The PLMA is washed in warm water and an 8-10 % dilute sodium

bicarbonate solution. Thoroughly wash the PLMA in tap water to clean

airway tube, drainage tube and cuff. The inflation valve fails if cleaning

solution enters into the valve. Care should be taken to prevent damage to

the valve.

The PLMA is sterilized by steam autoclaving method. Before

autoclaving the cuff should be fully deflated. Remove all water from the

cuff before autoclaving. Temperature used for autoclaving is up to 135

degree Celsius. After sterilization the device should be allowed to cool to

room temperature before use.

Figure 9 : LMA INSERTION:(17)

34

Figure 10 : PROSEAL LMA AND ITS PARTS

Figure 11: Patient end of LMA

Proseal. The drain continues to an

opening in the tip

Figure 12 : The dorsal aspect of

the cuff of Proseal LMA

35

Figure 13: PROSEAL LMA RADIOGRAPH

Figure 14 : PROSEAL LMA POSITION

36

Figure 15 : PROSEAL LMA DIFFERENT SIZES

Figure 16 : PROSEAL LMA INTRODUCER

37

INSERTION METHODS:(36–38)

Index finger insertion technique

Finger insertion technique is not recommended for proseal LMA sizes

1½ -2½. These sizes have a dedicated introducer

Hold the proseal LMA like a pen with the index finger pushed into

the introducer step

Under direct vision, press tip of the cuff upwards against the hard

palate and flatten the cuff against it. As the index finger passes further

into the mouth, finger joint begins to extend.

The jaws should not be held widely open.

Push the jaw downwards with middle finger or instruct the assistant

to pull lower jaw downwards momentarily using the index finger to

guide the device, press downwards towards the other hand, exerting

counter pressure

Advance the device into hypopharynx until a definite resistance is

felt. Full insertion is not possible unless the index finger is fully

extended and wrist is fully flexed.

The non-dominant hand is always brought from behind the head of the

patient in order to press down on the airway tube before removing the

finger.

38

This prevents the device from being pulled out of place when the finger

is removed and also permits completion of insertion if this has not been

achieved by the index finger alone. At this point the proseal LMA

should be correctly located with its tip firmly pressed up against the

upper oesophageal sphincter. Remove the finger.

DEVICE INFLATION:

Following insertion, the direction from which the tubes emerge

from the mouth is caudal. Without holding the tubes, inflate the cuff with

just enough air to obtain an intracuff pressure equivalent to approximately

60 cmH2O. Do not hold the tube during cuff inflation as this prevents the

mask from settling into its correct location. Never over inflate the cuff.

The following are the signs of correct placement may include one or

more of:

Slight outward movement of tube upon inflation

Presence of smooth oval swelling in the neck around the thyroid

and cricoid area

DEVICE FIXATION:

Once inflated, the device should be fixed in place with fish mouth

taping (maxilla to maxilla). While fixing, ensure that the tip of the mask

is pressed securely against the upper oesophageal sphincter. Correct

fixation is more critical for PLMA because any migration proximally of

the tip from hypopharynx will result in air leakage up the DT during IPPV.

39

PROBLEMS WITH PLMA PLACEMENT & APPROPRIATE

CORRECTIVE MANEUVERS

An inadequate depth of anaesthesia may result in coughing and breath

holding during insertion. Should this occur, anaesthesia should be

deepened immediately.

If the patient’s mouth cannot be opened sufficiently to insert the

mask, first ensure that the patient is adequately anaesthetized, the

help of an assistant may be needed to pull the jaw- downward.

The cuff must press against the palate throughout the insertion

maneuver; otherwise the tip may fold back on itself or impact on an

irregularity or swelling in the posterior pharynx (eq. Hypertrophied

tonsil). It is necessary to withdraw the mask and reinsert it if the cuff

fails to flatten or begins to curl over as it is advanced.

TESTS FOR PLACEMENT:(4)

1. Depth of insertion:(39)

It has been observed that when most of the bite block was outside

the patient’s mouth, PLMA was frequently malpositioned. For women,

mean depth of insertion has been found to be 18.6cm and for men

20.9cm.

40

2. Test for Obstructed Airway:

The rise and fall of the chest and square wave capnograph and

normal compliance of reservoir bag following manual ventilation

indicates unobstructed placement of PLMA.

3. Soap Bubble Test:(40)

Figure : 17 Soap Bubble Test

This is done to evaluate the seal with GIT. Non-toxic soap solution

is used to create a membrane over DT tip and dislodgement of membrane

happens following leak during IPPV.

Uses:

Confirms PLMA location behind cricoids cartilage.

Zero leak at PLMA Oesophageal junction is confirmed

With spontaneous ventilation it detects negative DT pressure

and aerophagia

Diagnoses oesophageal insufflation during IPPV.

41

4. Lubricant Jelly Test:

It evaluates seal with GIT. About 0.5 to 1 ml of lubricant jelly is

placed in the proximal end of the DT to seal it. If there is a leak from the

DT, the bolus of jelly is blown off.

5. Suprasternal notch tap test:(41)

This is used to determine whether the leading edge of PLMA lies

behind the cricoid cartilage. A non-toxic soap solution is placed across

the proximal end of DT creating a membrane. The suprasternal notch is

the gently tapped. A pulsating soap membrane with tapping confirms the

tip location behind cricoid cartilage.

6. Gastric Tube placement test:

When there is no leak up the DT, then insertion of gastric tube is

attempted via DT without using much force. This gives information

about the DT patency which is mandatory for safe use of PLMA.

OROGASTRIC TUBE INSERTION:(42)

The primary function of the draintube is to provide a separate

conduit from and to be alimentary tract. This is then passed down the DT

of PLMA without any haste or force. A slight resistance is normal felt as

the tip passes against upper oesophageal sphincter. There is an inherent

resistance to gastric tube insertion after 23cm of passage due to

42

angulation of nine degrees in the passage of DT to its tip. There may be

difficulty in passing gastric tube due to following reasons.

1. Selection of too large gastric tube

2. Inadequate lubrication

3. Use of cooled gastric tube

4. Cuff over inflation

5. Malposition of PLMA

The advantages of inserting gastric tube are

1. It allows removal of gas or fluid from the stomach

2. Confirm position/Patency of drainage tube

3. Functions as a guide to PLMA insertion if accidental

displacement occurs.

The disadvantages of inserting gastric tube are

1. Risk of tracheal placement

2. Oesophageal perforation rarely

3. The presence of gastric tube may trigger regurgitation by

interfering with oesophageal sphincter function.

4. Gastric tube blocks drainage tube so that gas and fluid can

not escape from oesophagus.

43

TEST FOR DT AIR LEAK AND PATENCY

Airleak

Large volume leaks are detected by listening over drainage tube or

feeling the air with hand. Small volume air leaks are detected best by

placing water-based lubricant or soap bubble over the end of drain tube.

TESTS FOR PATENCY

1. Passage of gastric tube

2. Passage of fibreopticscope(33)

3. Supra sternal notch tap test.

OTHER INSERTION TECHNIQUES:

Introducer method

Guided method

Thumb insertion method

180 degree rotation method

Proseal LMA, a variant of the classic LMA offers certain

distinctive advantages. It offers better seal, better inflation pressure and

the ability to decompress the stomach by passing a gastric tube through

the drain tube. The literature was searched and reviewed for using PLMA/

ETTin laparoscopic surgery.

44

1. MILLER DM, COMPOROTAL, et al IN 2006

Compared the efficacy of PLMA and SLIPA supra laryngeal

airways (SLA) with standard tracheal tube in 150 patients undergoing

daycare laparoscopic gynaecological surgery requiring general

anaesthesia.

An identical GA technique was used in all patients apart from the

addition of muscle relaxants and reversal drugs in ETT group. Ease of use,

quality of seal, ventilation, systolic pressure, response to intubation, side

effects and operating room time were assessed.

Both PLMA and SLIPA were easy to insert (100% success) and

ventilation with respective maximum sealing pressures of 31 and

30cmH2O (P= 0.4) with no muscle relaxants. The seal quality is both

PLMAand SLIPA permitted the use of low flows, 485 (291) and 539 (344)

mlx min(-1) (P= 0.2) respectively, although in the ETT group significantly

lower flows (377) (124 mlx min (-1) (P<0.01) were achieved.

Systolic pressure in the SLA group was more stable in response to

insertion than in ETT gp with PLMA, there was a lower incidence of

sorethroat than with ETT gp (30% vs 57%) (P< 0.05) and less difference

with SLIPA(30% vs 49%) (P>0.05).

With both SLA there was a significant reduction in operating room

time (> 3mts) (P<0.001).

45

The concluded that PLMA (reusable) and SLIPA (Single use) SLA’s

were easy to use without requiring muscle relaxants and less operating

room time compared to tracheal tube in daycare laparoscopies.

2. SHIN WJ, CHEONG YS, YANG HS:

(European Journal of Anaesthesia 2009 Nov.12)

Shin.wj and colleague compared PLMA(43), I-GEL and LMA-C to

assess insertion success rate , hemodynamic changes, seal pressure and

postop complication. They found that insertion success rate was similar in

these groups. There was no significant hemodynamic changes occurred in

these groups during insertion. The leak pressure was higher in both I- GEL

and Proseal LMA than the LMA- C. The postoperative complications

like sore throat were higher in LMA-C than other 2 devices (European

Journal of Anaesthesia 2009 Nov.12).

3. GIUSEPPE NATALINI MD,GABRIELLA LANZA MD,

ANTONIO ROSANO MD, et al IN 2002

Compared the frequency of airway seal and sorethroat(44) with

PLMA and std. LMA in 60 adults, ASA I, II & III patients undergoing

laparoscopic surgery under GA with controlled ventilation (Tidal volume

7ml/Kg, PEEP- 10cm H2O).

HR, BP, inspiratory and expiratory tidal volume, airway pressure,

EtCO2 and SpO2 were recorded. Leak fraction was calculated as the

46

difference between inspiratory and expiratory tidal volume divided by

inspiratory tidal volume. Postoperative sorethroat frequency was scored in

the recovery room (early) and 1 week after surgery (Late).

Leak fraction was 7+3% with LMA and 7+4% with PLMA

(P=0.731). Frequency of sorethroat is mild in 13% and 10% of patients

with LMA and PLMA respectively during the recovery room stay.

Hence they concluded that PLMA and LMA show similar air tight

efficiency and sorethroat evaluation performed in recovery room appears

as reliable as later evaluation.

47

MATERIALS AND METHODS

After obtaining institutional ethical committee approval this

prospective randomized study conducted in our institution. After getting

written informed consent 60 patients randomly alloted into 2 groups.

Group P – will receive proseal LMA

Group E – will receive Endotracheal tube intubation

INCLUSION CRITERIA

Either sex,

Age 20-65 years,

Body weight 40 – 75kg.

EXCLUSION CRITERIA

Pregnant Patients

Anticipated difficult airway

Obesity (BMI > 35kg/m2)

Oropharyngeal pathology,

Cardiopulmonary disease,

Cervical spine fracture or instability

Gastro-esophageal reflex disease

48

Anaesthesia Protocol:

A thorough preanaesthetic evaluation was done including history &

general examination.

All patients will receive T. Alprazolam 0.5mg and T.Ranitidine

150mg on the night before surgery and standard nil per oral protocol

followed. Patients shifted to OT, an IV line was secured with 18g venous

cannula, and an infusion of ringer lactate solution was started.

The patients connected to the monitor and the pre induction Systolic

BP, Diastolic BP, MAP, Heart rate, SPO2 are recorded.

Inj. Glycopyrrolate 0.01mg/kg iv, Inj. Midazolam 0.025mg/kg iv

will be given as premedication. Preoxygenation with 100%O2 for 3min

Patient induced with Inj. Fentanyl 2mcg/kg iv, Inj. Propofol 2mg/kg

iv, Inj. Lidocaine 1mg/kg iv and Inj. Succinyl Choline 2mg/kg iv. After an

adequate depth of anaesthesia is achieved, Proseal LMA is inserted by

index finger insertion method and connected to the anaesthetic machine

after confirming correct placement.

If the device insertion is not achieved, 2 extra attempts of placing

should try. If placements are unsuccessful after 3 attempts, the procedure

is discarded and the airway will be secured through other airway device

as appropriate and this case will be considered as a failed attempt.

The Proseal LMA was inserted by index finger insertion method.

The cuff was inflated with 20ml of air. Ventilation will be judged to be

49

optimal with sufficient chest rise, constant oxygenation SPO2 greater than

95% and absence of leak.

Successful placement of PLMA is defined by the following criteria

1. Square wave pattern on capnography

2. No air leak over mouth, stomach, drain tube

3. Positive suprasternal notch tap test.

4. Effective ventilation (TV> 8ml/Kg, EtCO2<45 mmHg).

Endo Tracheal Tube was inserted using chin lift position.

Ventilation will be judged to be optimal with sufficient chest rise, constant

oxygenation SPO2 greater than 95% and absence of leak.

Maintenance of anaesthesia done by N2O:O2-66:33%, Sevoflurane

0.25-1% along with Inj. Vecuronium 0.1mg/kg depending upon the need

and depth of anaesthesia for that surgery.

All patients were monitored continuously. At the end of procedures,

residual neuromuscular blockade was reversed with Inj. Neostigmine

0.05mg/Kg and Inj. Glycopyrolate 0.01mg/Kg and the Proseal LMA (or)

Endo Tracheal Tube was removed after adequate recovery of muscle

power.

The patient shifted to postoperative ward after full recovery.

50

Parameter evaluated:

All patients will be monitored continuously for

Heartrate – preoperative, intraoperative and after insertion, after

pneumoperitoneum, after removal of device.

Mean Arterial Pressure and ETCO2–preoperative, intraoperative,

after insertion, after pneumoperitoneum, after removal of device.

SPO2- preoperative, intraoperative, after insertion, after

pneumoperitoneum, after removal of device.

The ease of insertion, number of attempts and duration every try

(time from taking the device to checking of bilateral airway).

The leak can be tested by placing the stethoscope over mouth,

epigastrium and drain tube end to hear any leak.

Post operatively each patient will be questioned for the following

complications

Throat pain, sore throat.

Dysphagia.

Dysphonia (difficulty (or) pain with speaking).

Nausea and vomiting.

Hoarseness of voice.

51

Complication such as incidence of any airway complication will be

evaluated

Postextubation cough,

Breath holding,

Laryngospasm.

Bronchospasm, regurgitation.

Presence of blood on the devices

Lip, oralmucosal, pharynx trauma.

All cases will be questioned to verify any of the complications in postop

room & 24hrs postoperatively.

Sorethroat, throatpain

Nausea, vomiting

Dysphagia.

Hoarseness of voice.

Followup period:

Patient will be followed up for 24hrs in post-operative ward to verify

any complications.

Statistical analysis:

The data will be analysed using SPSS version 16.0 for windows 7.

52

RESULTS

A total of 60 patients were subjected to anesthesia by two different

anesthesia delivery devices namely Proseal Laryngeal Mask Airway and

the standard cuffed Endo Tracheal Intubation.

The following are the observations of the study.

Demographic profile

The mean age among all the respondents was 38.02 years with a

standard deviation of ± 13.584. The minimum age group encountered was

18 years and the maximum was 65 years. Female subjects were more

58.3% in comparison to males 41.7%.

53

Table 7 : Demographic profile of study participants

Age group Number (n) Percentage (%)

< 20 years 3 5.0

20 – 35 years 26 43.3

36 – 50 years 18 30.0

51 – 65 years 13 21.7

Sex

Male 25 41.7

Female 35 58.3

Figure : 18 Age distribution among study participants

54

Table 8 : Age and Sex distribution among PROSEAL LMA and ETT

Age group PROSEAL LMA ETT

Number (percentage) Number (percentage)

< 20 years 1 (3.3) 2 (6.7)

20 – 35 years 15 (50.0) 11 (36.7)

36 – 50 years 10 (33.3) 8 (26.7)

51 – 65 years 4 (13.3) 9 (30.3)

Total 30 (100) 30 (100)

Sex

Male 12 (40.0) 13 (43.3)

Female 18 (60.0) 17 (56.7)

Figure : 19 Age distribution among PLMA and ETT Groups

55

Statistical analysis: PROSEAL LMA vs ETT

The mean age of the respondents who received PROSEAL LMA is

35.73 years while those in the ETT group had a mean age of 40.30. The

difference in the mean age of the PROSEAL LMA and ETT groups is

4.567 years and this difference is not statistically significant (p= 0.195).

Hence both the groups are comparable in terms of age distribution.

Table 9 : Age difference between PLMA and ETT

Group No Mean SD Mean

Difference

p

value

95% confidence

interval

Upper Lower

PROSEAL

LMA

30 35.73 ± 12.798 4.567 0.195 2.412 11.545

ETT 30 40.30 ± 14.172

56

Table 10 : Average number of attempts

Group No 1st attempt 2nd attempt Odd’s

ratio

p value

PROSEAL

LMA

30 28 2 1.56 0.038

ETT 30 27 3

PLMA insertion was successful in 28/30 cases in first attempt, while

2 /30 patients required second attempt. With ETT 27/30 had successful

intubation during first attempt and 3/30 had second attempt.

Using a PROSEAL LMA had 1.56 less chances of intubation during

second attempt when compared to ETT and this association between

reintubation and PROSEAL LMA was statistically significant with a p

value of 0.038 (p< 0.05).

57

Table 11 : Time taken for insertion

Group No Mean SD p value

PROSEAL LMA 30 13.30 ± 3.042 0.0012

ETT 30 16.17 ± 3.445

The time taken for PLMA/ETT includes time taken from

introduction into oral cavity to the final confirmation of its proper

positioning. Time taken for intubation with PLMA is 13.30 seconds and

with ETT is 16.17 seconds. Proseal LMA inserted 3 seconds earlier than

Endotracheal tube intubation and P value indicates that this difference is

statistically significant.

Table 12: Ryle’s Tube insertion- number of attempts

Attempts PLMA ETT

1st Attempt 28(93.3%) 22 (73.3%)

2nd Attempt 2(6.67%) 6 (20%)

3rd Attempt - 2(6.67%)

58

The number of attempts at insertion of Ryle’s tube insertion

was successful in 1st attempt using PLMA as it gave a separate

channel for isolating the digestive tract. Further the insertion of

Ryle’s tube was possible in 6.67% of subjects with 3 rd attempt when

using ETT as the intubating device. This shows the ease with which

Ryle’s tube may be inserted when using PLMA as the intubating

device.

Figure : 20

59

Table 13: Time taken for insertion of Ryle’s Tube

Group No Mean SD p value

PROSEAL

LMA

30 11.13 ± 2.014 0.0004

ETT 30 13.12 ± 2.117

Figure : 21 Ryle’s Tube Insertion time

Time taken for intubation with PLMA is 11.30 seconds and with

ETT is 13.12 seconds. Student’s t test reveals P value of 0.0004 which is

significant. This indicates there is difference in Ryle’s tube insertion time

between PLMA and ETT which is statistically significant.

60

POSTOPERATIVE AIRWAY MORBIDITY

Table 14: Postoperative Airway Morbidity

Groups Yes No Mean

Standard

Deviation

Sore

Throat

PLMA 1 29 1.96 0.20

0

t=1.41

P=0.161 Not

Significa

nt

ETT 4 26 1.84 0.37

4 Laryngo

Spasm

PLMA 0 0 2.00 0.

0

Not significant

ETT 0 0 2.00 0.0

0

Postoperative sorethroat and laryngospasm were assessed for 24

hours postoperatively. Sorethroat occurred in 1/30 cases with PLMA and

4/30 cases with ETT. Laryngospasm did not occur in both the groups.

Through documented data are clinically relevant statistical analysis reveals

P Value of 0.164 which is not significant. Hence incidence of postoperative

airway morbidity is same in both the groups.

Heart rate

Mean heart rate during preinduction time for PROSEAL LMA is

83.10 bpm and that of ETT is 88.80 bpm. The mean heart rates at 10

seconds, 1 minute, 3 minutes and 5 minutes after insertion of PROSEAL

LMA were 85.30, 80.47, 80.27 and 82.03 bpm respectively while the mean

heart rates at 10 seconds, 1 minute, 3 minutes and 5 minutes after insertion

of ETT were 87.43, 87.93, 90.53 and 89.03 bpm. Statistical analysis shows

61

that p values for preinduction heart rates, heart rates at 10 seconds, 1 minute

after insertion of PROSEAL LMA was 0.081, 0.0540 and 0.076 and were

not statistically significant. However, the p values for heart rates at 3 and

5 minutes after insertion of PROSEAL LMA was 0.012 and 0.033 and is

statistically significant thereby showing that there is difference in the mean

heart rates after insertion of PROSEAL LMA and ETT. The mean heart

rate following pneumoperitoneum was 87 bpm in PROSEAL LMA group

and 88.70 in the ETT group. The difference in mean heart rates following

pneumoperitoneum was not statistically significant with a p value of 0.666.

The mean heart rates following extubation was 88.43 and 95.43 bpm in the

PROSEAL LMA and ETT groups respectively. This difference in heart

rates following extubation was statistically significant with a p value of

0.018 (<0.05)

62

Table 15: Hemodynamic Response – Heart Rate

Group No Mean SD p value

Preinduction

PROSEAL

LMA 30 83.10 ± 11.028 0.081

ETT 30 88.80 ± 13.659

10 secs after

PROSEAL

LMA 30 85.30 ± 12.863 0.0540

ETT 30 87.43 ± 13.908

1 min after

PROSEAL

LMA 30 80.47 ± 17.585 0.076

ETT 30 87.93 ± 14.246

3 min after

PROSEAL

LMA 30 80.27 ± 17.213 0.012

ETT 30 90.53 ± 13.198

5 min after

PROSEAL

LMA 30 82.03 ± 12.607 0.033

ETT 30 89.03 ± 12.263

After

pneumoperitoneum

PROSEAL

LMA 30 87.00 ± 14.494 0.666

ETT 30 88.70 ± 15.853

After extubation

PROSEAL

LMA 30 88.43 ± 10.013 0.018

ETT 30 95.93 ± 13.595

63

Figure : 22

Figure : 23

0

20

40

60

80

100

120

140

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30

Heart Rate - PLMA Group

10 seconds 1 min 3 min

5 min after pneumopritoneum after extubation

0

20

40

60

80

100

120

140

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30

Heart Rate - ETT Group

10 sec 1 min 3 min

5 min after pneumoperitoneum after extubation

64

Mean Arterial Blood Pressure

Mean arterial pressure during preinduction time for PROSEAL

LMA is 88.87mmHg and that of ETT is 94.70mmHg. The mean arterial

pressure at 10 seconds, 1 minute, 3 minutes and 5 minutes after insertion

of PROSEAL LMA were 86.53, 83.03, 84.57, and 83.77mmHg

respectively while the mean heart rates at 10 seconds, 1 minute, 3 minutes

and 5 minutes after insertion of ETT were 89.67, 88.60, 84.73 and 87.10

mmHg. Statistical analysis shows that p values for preinduction Mean

arterial pressure, at 10 seconds, 1 minute, 3 minutes and 5 minutes after

insertion of PROSEAL LMA was 0.088, 0.320, 0.094,0.961 and 0.324 and

were not statistically significant. The mean arterial pressure values

following pneumoperitoneum and extubation were 91.50 and 102.93

mmHg for the PROSEAL LMA group and 94.47 and 100.43 for the ETT

groups respectively. The p values for heart rates after pneumoperitoneum

following PROSEAL LMA was 0.013 and is statistically significant

thereby showing that there is difference in the mean arterial pressure

following pneumoperitoneum after insertion of PROSEAL LMA and ETT.

65

Table 16: Haemodynamic response – Mean arterial pressure

Group No Mean

(mmHg)

SD p value

Preinduction

PROSEAL

LMA

30 88.87 ± 14.137 0.088

ETT 30 94.70 ± 11.742

10 secs after

PROSEAL

LMA

30 86.53 ± 13.182 0.320

ETT 30 89.67 ± 10.902

1 min after

PROSEAL

LMA

30 83.03 ± 14.495 0.094

ETT 30 88.60 ± 10.506

3 min after

PROSEAL

LMA

30 84.57 ± 15.348 0.961

ETT 30 84.73 ± 10.422

5 min after

PROSEAL

LMA

30 83.77 ± 13.913 0.324

ETT 30 87.10 ± 11.978

After

pneumoperitoneum

PROSEAL

LMA

30 91.50 ± 15.104 0.013

ETT 30 102.93 ± 19.278

After extubation

PROSEAL

LMA

30 94.47 ± 11.554 0.070

ETT 30 100.43 ± 13.434

66

Figure : 24

Figure : 25

0

20

40

60

80

100

120

140

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30

Mean Arterial Pressure - PLMA Group

10 sec 1 min 3 min 5 min after pneumoperitoneum after extubation

0

50

100

150

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30

Mean Arterial Pressure - ETT Group

10 sec 1 min' 3 min

5 min after pneumoperitoneum after extubation

67

ETCO2

ETCO2 during preinduction time for PROSEAL LMA is

30.20mmHg and that of ETT is 30.13mmHg. ETCO2 at 10 seconds, 1

minute, 3 minutes and 5 minutes after insertion of PROSEAL LMA were

31.16, 30.74, 31.80, 32.21 and 31.90 mmHg respectively while the mean

heart rates after insertion of ETT at 10 seconds, 1 minute, 3 minutes and 5

minutes were 30.74, 30.74, 30.75 and 30.57 mmHg. The ETCO2 values

following pneumoperitoneum and extubation were 33.74 and 32.96 mmHg

for the PROSEAL LMA group and 31.51 and 32.81 for the ETT groups

respectively. The p values for ETCO2 after pneumoperitoneum and

extubation following PROSEAL LMA was 0.080 and 0.881 and is

statistically not significant thereby showing that there is no difference in

the ETCO2 levels following pneumoperitoneum and extubation between

the two groups.

68

Figure : 26

Figure : 27

0

10

20

30

40

50

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30

ETCO2 PLMA

10 sec 1 min 3 min

5 min after pneumoperitoneum after extubation

0

10

20

30

40

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30

ETCO2 - ETT

10 sec 1 min 3 min

5 min after pneumoperitoneum after extubation

69

Table 17: Haemodynamic response – ETCO2

Group No Mean SD p value

Preinduction

PROSEAL

LMA 30 30.20 ± 3.827 0.946

ETT 30 30.13 ± 3.730

10 secs after

PROSEAL

LMA 30 31.16 ± 3.097 0.657

ETT 30 30.74 ± 4.172

1 min after

PROSEAL

LMA 30 31.80 ± 3.210 0.230

ETT 30 30.74 ± 3.567

3 min after

PROSEAL

LMA 30 32.21 ± 3.504 0.140

ETT 30 30.75 ± 4.016

5 min after

PROSEAL

LMA 30 31.90 ± 3.722 0.223

ETT 30 30.57 ± 4.554

After

pneumoperitoneum

PROSEAL

LMA 30 33.74 ± 4.500 0.080

ETT 30 31.51 ± 5.167

After extubation

PROSEAL

LMA 30 32.96 ± 3.978 0.881

ETT 30 32.81 ± 3.777

70

DISCUSSION

The study conducted to compare the two-airway device Proseal

LMA and Endo Tracheal Tube (ETT) in view of ease of insertion, number

of attempts, hemodynamic changes and postoperative adverse events. The

study was conducted to 60 patients of both sexes aged 18–65 years going

for elective surgical procedures with spontaneous ventilation. Both the

devices provide patent airway during PPV(45,46). Both devices also reduce

the incidence of gastric insufflations and regurgitation.(47)

DEMOGRAPHIC PROFILE

Age distribution

The above study shows that the mean age group of Proseal LMA

is 35.73 years and that of ETT is 40.30 respectively and this difference

in age between the two groups is not statistically significant (P˃0.05). This

shows that both the groups have similar distribution of age and the

difference noted is because of chance. Studies by Malby et al(48) comparing

PLMA with ETT on patients undergoing laproscopic cholecystectomy

also show similar age group profiles with mean age among PLMA being

38.12 and ETT being 41.22 years respectively. Similarly Randomized

Controlled studies by Griffiths et al(49) on comparison of Proseal LMA and

ETT also showed similar age group patterns with mean age among PLMA

71

subjects was 34.75 and that of ETT being 38.21 years respectively.

Sex distribution

In this study is 12/30 and 18/30 respectively. Similarly the

distribution of male and female subjects in ETT group is 13/30 and 17/30

respectively. Studies by Maltby et al also have similar sex distribution

among respondents.

NUMBER OF ATTEMPTS TO SUCCESSFUL PLACEMENT

Studies by Evans.N, Gardner.S.V et al(50) in 300 patients assessed

the insertion characteristics, airway seal pressures etc using proseal LMA

have shown that insertion was successful in 94% of patients and easy in 91

% of patients. The findings of our study are in concurrence with the above

data. The success rate of PLMA was 95% in our study and it had 1.56 times

less chances of 2nd intubation when compared to ETT and this association was

statistically significant with a the P value of 0.038. Miller DM, camporotaL,

etal(51) in 2006 compared PLMA and SLIPA with ETT in 150 patients. Both

PLMA and SLIPA were inserted in 1st attempts (100% success) and

ventilated with maximum sealing pressure of 30cm H2O (P=0.4) with no

muscle relaxant.

72

TIME TAKEN FOR INTUBATION

Miller DM, CamporotaL, et al(51) in 2006 compared PLMA, SLIPA

with ETT in 150 anaesthetised patients undergoing daycare laparoscopic

surgery. They concluded PLMA and SLIPA were easy to use and less

operating room time (P=< 0.001) was required compared to ETT in

daycare laparoscopies. In our study a mean difference of 2.80 seconds is

noted between use of PLMA and ETT and this difference was found to be

statistically significant (P= 0.0012).

PULMONARY VENTILATION

Roger Maltby, Michael Beriauletal(48) in 2002 analysed PLMA and

ETT in 109 patients undergoing laparoscopic cholecystectomy and

concluded no statistically significant differencein SpO2/ EtCO2 between

two groups. This result is comparable with our study result which shows

no significant EtCO2 changes (P= 0.946, 0.657, 0.230, 0.140, 0.223)

measured Pre-op, Pre intubation, 1mt, 3mt and 5mt after intubation, after

peritoneal inflation and after extubation. J. Roger Maltby,(45)et al,

compared PLMA and ETT in 209 women undergoing laparoscopic

gynaecological surgery, concluded no statistically significant difference

between PLMA and ETT groups for SpO2, EtCO2 before or during

peritoneal insufflation in short and long period of peritoneal inflation. The

results are comparable with our study.

73

POST OPERATIVE AIRWAY MORBIDITY

In our study sorethroat occurred 4/30 cases with ETT while it

occurred only in 1 patient out of 30 in the PLMA group. Laryngospasm

did not occur in both the groups. Through documented data are clinically

relevant statistical analysis reveals P Value of 0.176 which is not

significant. Though there is difference in incidence of post operative

airway morbidity especially with regard to sore throat, it is nor statistically

significant and hence we conclude that the post operative airway

morbidity is the same in both the groups. However studies by Miller DM,

Camporota. L, et al(51) in 2006 in their study on 150 patients, concluded

that lower incidence of sorethroat with PLMA than with ETT group (30%

Vs 57% and P value < 0.05).This might be due to the lesser sample size in

our study with 60 patients compared to 150 patients. Hohlrieder M,

Brimacombe J, et al(52) in 2007 compared PLMA with ET in 200 female

patients, concluded that less frequency of sorethroat with PLMA (12% Vs

38%, P <0.001). Though this result is comparable with our study statistical

significance was not achieved due to smaller sample size.

HEMODYNAMIC CHANGES

Mean arterial pressure changes were noted in our study especially

after pneumoperitoneum following use of Proseal LMA and ETT and this

difference is statistically significant with P values of 0.013 thereby making

74

it evident that use of PLMA is associated with less chances of increase of

mean arterial pressure. Studies by Vannila et al(53) shows an increase in

Mean Arterial Pressure increased in the ETT group, but however the

hemodynamic changes were reflected in other parameters like changes

at 10 seconds, 1 minute, 3 minutes and following extubation. In our

study though there was difference in the mean arterial pressure values

between PLMA and ETT, with a lower values being recorded with PLMA

the difference was not statistically significant. Similarly studies by Kiran

et al(23) showed that the values of mean arterial pressure after LMA

insertion were significantly lower compared to tracheal intubation after

1,3 and 5 minutes when compared to ETT insertion.

The heart rate changes were much less in the PLMA group

compared to ETT group and these differences in heart rate is statistically

significant at 3 minutes, 5 minutes and after extubation with P values of

0.012, 0.033 and 0.018. These findings are consistent with studies done

by Songsong Mao et al(54) on intubation characteristics between laryngeal

mask airway and endotracheal intubation for anesthesia in adult patients

undergoing laparoscopic surgeries.

75

SUMMARY

The present study was conducted with the aim to compare the

intubation characteristics between Proseal LMA and Endo Tracheal Tube

among patients posted for laparoscopic surgeries in Department of

Anaesthesiology, Government Theni Medical College & Hospital, Theni.

Totally 60 patients posted for elective surgeries were selected those who

fulfill the inclusion criteria. Prospective randomized clinical trial study

design was adopted. The study design selected for this study was

systematic random sampling. The protocol was prepared based on the

guidelines. Ethical clearance was obtained from the Institutional Ethical

Committee. Informed consent was obtained after explaining the purpose

of the study. The data was collected from March 2018 to May 2019. The

study population was divided into 2 groups in which Proseal LMA was

used for intubation in Group P and Group E Endo Tracheal Tube was

used. Hemodynamic parameters like Blood pressure (systolic, diastolic

and mean arterial pressure), Heartrate and Oxygen saturation were

recorded at Baseline, 10seconds, 1minute, 3minute, 5 minute, after

pneumoperitoneum and after extubation. Duration of Proseal LMA

insertion [from the period of insertion of LMA to the checking of bilateral

air entry] was recorded.

76

Results showed that there was no statistical significant difference in mean

age, gender distribution, weight, diagnosis and ASA risk between two

groups and hence all the two groups were comparable.

The use of Proseal LMA may offer some advantages over

endotracheal intubation especially in the management of pressor response

where the control of mean arterial pressure plays a vital role.

The changes in mean heart rate were much lesser in the Proseal

LMA group compared to ETT group with the difference being significant

at 3 min, 5 min and after extubation. This could prove of P value especially

in patients whose heart rate monitoring requires intensive management

principles following surgical procedures.

77

CONCLUSION

Results of this study suggest that patients intubated using Proseal LMA

have desirable hemodynamic stability compared to patients intubated using

Endo Tracheal Tube. In addition to the favorable side effect profile, lesser

intubation time, ease of insertion of Ryle’s tube and airway maintenance though

was better in the PLMA group. Due to the significant difference in various

parameters observed with Proseal LMA in comparison to ETT, it may be stated

that the proseal LMA is a better intubation device compared to ETT thereby

proving its efficacy.

78

LIMITATIONS

This study excluded the patients with airway problems, as these

patients require longer intubation time, which can result in different

outcomes.

This study was conducted on patients with ASA I and II. Making

such comparisons on patients with underlying cardiac diseases may

bringout different results.

Depth of anaesthesia was not monitored in the study.

Plasma corticosteroid concentrations were not measured.

ANNEXURE - I

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ANNEXURE - II

MASTER CHART

ABBREVIATIONS USED IN MASTER CHART

PLMA Proseal Laryngeal Mask Airway

ETT Endo Tracheal Tube

A Age

S Sex

Int Intubation device used

Att Number of attempts at insertion

T Time for insertion of intubation device

RTA Number of attempts at insertion of Ryle’s tube

RT Time for insertion of Ryle’s tube

PI Pre induction

AP After Pneumoperitoneum

AE After extubation

ANNEXURE - III

ANNEXURE – IV

ETHICAL COMMITTEE APPROVAL CERTIFICATE

ANNEXURE - V

PLAGIARISM REPORT

ANTI PLAGIARISM CERTIFICATE

This is to certify that this dissertation work titled, entitled “COMPARISON

OF PROSEAL LARYNGEAL MASK AIRWAY AND ENDOTRACHEAL

TUBE IN PATIENTS UNDERGOING LAPAROSCOPIC SURGERIES”

submitted by Dr.K.MAYILVANAN with registration number 201720753 for the

award of MASTER DEGREE in the branch of ANAESTHESIOLOGY has been

personally verified by me in urkund.com website for the purpose of plagiarism check.

I found that the uploaded thesis file contains from introduction to conclusion pages

and result shows 14% percentage of plagiarism in the dissertation.

Guide and supervisor sign with seal

Prof. DR.M.BALASUBRAMANI,

MD., DA.,

Professor and Guide,

Department of Anaesthesiology,

Govt Theni Medical College,

Theni.