Martin Moon, May 2010
BARTS AND THE LONDON NHS TRUST
ELECTROPHYSIOLOGICAL PROCEDURES
&
NURSE ADMINSITRATION OF INTRAVENOUS MODERATE
SEDATION
(essential supporting and background information for nursing IVMS
competencies)
Review Date:
Approval/Adopted:
Original Distribution: All Electrophysiology Consultants,
All Anaesthetic Consultants associated with Electrophysiology Cath
Labs (SBH)
All Electrophysiology Cath Lab Staff (SBH)
Related Topics: Trust policy for the safe and secure handling and administration of
medicine within Bart‟s and the London NHS trust
(BLT/POL/13561/NQA)
Controlled Drugs Procedure in the Electrophysiology Cath Labs
(SBH). (BLT/POL/RIT/00004/DITSS)
Trust Waste Disposal Policy (BLT/POL/RIT/17902/PATH)
Protocol, Standard & Competency for Nurse Preparation &
Administration of IV Moderate Sedation in Combination with Local
Anaesthesia
Policy for the Administration of Injectable Medicines in Clinical
Areas (Trust Core Policy) (BLT/POL/12709/PHA – 1)
Policy for the Safe and Secure Handling and Administration of
Medicines (BLT/POL/13007/PHA)
Policy for the Handling of Controlled Drugs (BLT/POL/13408/NTQ)
Incident Reporting (BLT/POL/20906/RM)
Prevention of Central Venous Catheter & Peripheral cannulae
infection (BLT/GUI/27008IC)
Infection Control Policy (BLT/POL/32408/IC)
Policy for Identification and Documentation of Medication Allergies
and Severe Drug Reactions (BLT/POL/30708/PHA)
Patient Group Directions Policy (BLT/POL/00807(B)/N&Q)
Policy and Guidelines for the Administration of Intravenous Drugs
(BLT/POL/12704/PHA)
Policy for Patient Identification Bands and Red Alert Bands
(BLT/POL/03105/NQA)
Hand Hygiene (BLT/POL/19308/IC)
MRSA Policy (BLT/POL/25303/IC)
Intravenvous Drugs (Peripheral) (BLT/POL/12704/PHA)
Checking of Patients into the Electrophysiology Cath Labs
Safe Use and Disposal of Sharps
Prevention of Exposure with Blood-borne Pathogens
Author RN Martin Moon – Clinical Teaching Charge Nurse (Cardiac Angiography)
with
Dr. Simon Sporton – Clinical Lead Consultant (Electrophysiology)
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CONTENTS ELECTROPHYSIOLOGICAL PROCEDURES & NURSE
ADMINSITRATION OF INTRAVENOUS MODERATE SEDATION
(essential supporting and background information for nursing IVMS
competencies) introduction
Definition (an IVMS nurse)
Application of this competency assessment
Definitions of Sedation and Anaesthesia
Competency criteria for IVMS administration
1. Pre-sedation Assessment:
2. Pre Procedure Equipment and Drug Preparation.
3. Procedural Patient Care
4. Post Sedation Procedure
5. Audit
APPENDIX ONE
Competency Table for Nursing Sedation
APPENDIX TWO
IVMS Drugs Dosage Protocol
APPENDIX THREE
Cath Lab Safer Surgery Checklist
APPENDIX FOUR
Components of Pre-Sedation Patient Assessment
APPENDIX FIVE
American Society of Anaesthesiologists (ASA) Classification of Physical Status
APPENDIX SIX
Assessment of patient airway
APPENDIX SEVEN
Patients that should not undergo nurse administration of IVMS
APPENDIX EIGHT
Fasting Guide Lines
APPENDIX NINE
National Patient Safety Association Report
APPENDIX TEN
Differential Diagnosis of Complications During IVMS
APPENDIX ELEVEN
Components of Post sedation handover
APPENDIX TWELVE
Individual Authorisation
3
3
3
4
5
5
6
7
9
9
10-14
15-17
18
19-20
21
22-23
24
25
26
27
28
29
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ELECTROPHYSIOLOGICAL PROCEDURES & NURSE ADMINSITRATION OF
INTRAVENOUS MODERATE SEDATION (essential supporting and background
information for nursing IVMS competencies)
Introduction:
Under the duty of care, Bart‟s and the London NHS Trust have a responsibility to act in the
best interests and maintain the safety of all patients for whom it is responsible. An essential
element of maintaining the safety of patients undergoing electrophysiological procedures
under the administration of IV moderate sedation (IVMS) is to ensure that all equipment and
drugs are correctly prepared and administered by the sedation practitioner.
Definition (an IVMS nurse): an IVMS nurse is defined (for this document) as a nurse
working within the electrophysiology Cath Labs at Saint Bartholomew‟s Hospital who has
completed a course of departmental competencies associated with IVMS, is able to
demonstrate an in-depth understanding of issues surrounding IVMS, and has been assessed as
and deemed competent to undertake the administration of IVMS by an electrophysiology
(EP) consultant. Administration of the IVMS drugs is under verbal prescription from the
electrophysiologist (thus IVMS remains electrophysiologist led), and is prepared and
administered according to the EP departments IVMS Policy, Standard and Competency
(Protocol, Standard and Competency for Nurse Administration of IV Moderate Sedation in
Combination with Local Anaesthesia). An IVMS nurse will be deemed competent at
administering IVMS by satisfying the criteria described in this document, and be provided
with an “Individual Authorisation” certificate (see Appendix 12).
Application of this competency assessment:
It is the responsibility of the IVMS nurse and the electrophysiologist to ensure that patients
have safe IV administration of moderate sedation during the proposed procedure and receive
safe recovery care.
For nurses to undertake IVMS administration it is essential that they have undertaken and
achieved the competency framework for advanced sedation, and have been assessed by a
consultant electrophysiologist. (See Appendix 1)
If deemed competent the IVMS nurse will be issued with a certificate to administer IVMS. If
at any time it is felt that the IVMS nurse is no longer competent to administer drugs, and
monitor the effects (and initiate interventional measures if required), this certificate will be
revoked and only reinstated after a period of formal retraining has been completed and that
they are deemed competent after re-assessment by consultant anaesthetists.
The IVMS nurse must hold a qualification in IV drug administration and intermediate life
support (ILS) which is updated every year.
A minimum of three senior practitioners within the department shall hold the current
qualification of advanced life support (ALS).
Undertaking these skills and competencies will ensure that practitioners have achieved the
educational knowledge required to undertake the safe administration of IVMS agents.
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Definitions of Sedation and Anaesthesia:
IVMS nurses are not to practice deep sedation. They must know how to recognise deep
sedation on the „7 stages of anaesthesia continuum‟ (Krozek & Scroggins on behalf of the
Joint Commission on Accreditation of Healthcare Organisations (JCAHO)), 2001), and be
able to clearly demonstrate the potential for deterioration in patients undergoing moderate
sedation, and what measures may be implemented. IVMS nurses MUST therefore know how
to recognise and rescue this situation.
The Royal College of Anaesthetists & the American Society of Anaesthesiologists (1999)
defines the four levels of sedation as:
Light Sedation
A drug induced state during which patients respond normally to verbal commands.
Although cognitive function and coordination may be impaired, ventilatory and
cardiovascular functions are unaffected.
Moderate Sedation
A drug induced depression of consciousness during which patients respond
purposefully to verbal commands, either alone or accompanied by light tactile
stimulation. No interventions are required to maintain a patent airway, and
spontaneous ventilation is adequate. Cardiovascular function is usually maintained.
Deep sedation
A drug induced depression of consciousness during which patients cannot be easily
aroused but respond purposefully after repeated or painful stimulation. It is considered
a state whereby the patient may become compromised in the independent
maintenance of their own airway and anaesthetic intervention may be required.
Anaesthesia
Consists of general anaesthesia and spinal or major regional anaesthesia. It does not
include local anaesthesia. General anaesthesia is a drug induced loss of consciousness
during which patients are not arousable, even by painful stimulation. The ability to
independently maintain ventilatory function is impaired. Patients often require
assistance in maintaining a patent airway, and positive pressure ventilation may be
required because of depressed spontaneous ventilation or drug induced depression of
neuromuscular function.
Krozek & Scroggins (on behalf JCAHO, 2001) recommend the term “IV moderate sedation”
replace “conscious sedation” to remove ambiguity from the 7 stages of the anaesthesia
continuum:
1) local anaesthesia – topical or regional use of a drug
2) minimal sedation – (anxiolysis) there may be slight cognitive or co-ordination
impairment, but patient responds readily to verbal commands whilst in a drug induced
state
3) sedation – altered state of consciousness resulting in euphoria, relaxation and amnesia
4) moderate sedation – state of drowsiness or feeling sleepy (see above)
5) deep sedation / analgesia – depressed consciousness (almost unconscious) controlled
or initiated by drugs which may (authors‟ emphasis) result in swift progression to loss
of protective reflexes
6) anaesthesia – deliberate drug induced and controlled state of unconsciousness with
loss of protective reflexes: general anaesthesia is where the loss of the independent
airway occurs and response to physical stimulation is absent
7) loss of protective reflexes – complete absence of gag reflex.
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EP consultants aim to maintain a level between “local anaesthesia” and “moderate sedation”
hence it is essential IVMS nurses be able to demonstrate an understanding that anaesthesia is
a continuum, and that patients are able to swiftly move form one stage to the next (Krozek &
Scroggins, 2001; Vitkun & Epstein, 2000; Foster, 2000; Kost, 1998). Due to this continuum
and potential for patient deterioration, this protocol includes criteria and parameters for
patient monitoring.
Competency criteria for IVMS administration
1. Pre-sedation Assessment:
Nurses administering IVMS should be familiar with sedation-orientated aspects of the
patient‟s medical history and how these might alter the patient‟s response to both sedation
and analgesia agents.
Theses include:
Abnormalities of the major organ systems.
Previous adverse experience with general anaesthesia, regional anaesthesia or IVMS.
Drug allergies, current medication and potential drug interactions.
Time and nature of last oral intake.
History of tobacco, alcohol or substance use/ abuse.
1.1 The IVMS nurse will correctly identify the patient and assess his/her
suitability for sedation / analgesia administration, This information will gathered by
reviewing the information gathered as a part of the “Competency and Standard for
Health Care Professionals to Admit Patients Undergoing Electrophysiology
Procedures to SBH Angiography Department.”
It is not appropriate for the IVMS nurse to meet the patient for sedation for the first
time on the procedure table. For this reason the patient can only be moved into the EP
cath lab after they have been assessed by the IVMS nurse.
1.2 Pre-sedation assessment must be conducted in an unhurried, reassuring atmosphere.
Adequate time must be allowed to alleviate the patient‟s anxiety while allowing
sufficient time to gather data and answer the patient‟s questions. Data reviewed will
include that set out as a part of Appendix 4
1.3 When undertaking patient assessment, the following should be assessed and
recognised as a part of, and is documented within, the integrated care pathway (ICP)
Patient age, height and weight
Proposed procedure
Name of sedation Practitioner
Allergies
Medical History
Surgical History
Possible Pregnancy
Current Medications
Dentition
Social History
Nil By Mouth Status
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The BLT NHS Trust “Diagnostics and Therapeutics & Surgery and Anaesthesia Policy for
Nurse Administration of Intravenous Conscious Sedation” recommends IVMS nurses also
consider:
ASA status (see appendix 5)
Airway assessment (see appendix 6)
1.4 If the patient fails to meet the departmental criteria for nurse administration of IVMS
set out in the assessment guidelines, the senior electrophysiologist must be informed.
If appropriate the patients procedure should be postponed to a later time or if required
be referred to an anaesthetist for further consultation and assessment. The
electrophysiologist and anaesthetist will review the patient and if necessary refer the
patient for anaesthetic cover and rebook the case.
1.5 If a patient fails to meet the criteria and the case is either an emergency or out of
hours („on-call‟) the anaesthetic coordinator should be contacted for advice. If within
normal hours and an elective case the Consultant anaesthetists linked to the
department should be contacted.
1.6 Once the assessment is complete, and if the patient is suitable for sedation, the
electrophysiologist will consent the patient and review the risk, benefits, options and
potential complications involved on the procedure.
1.7 The patient should have a minimum size of 20 G cannuale in situ (preferably ante
cubal fosa) before sedation. This is either inserted after the assessment or if a patient
arrives with cannulae from the ward, the IVMS nurse should establish that the
cannuale is patent and flushes easily before proceeding.
1.8 Any patient meeting the Exclusion Criteria for IVMS sedation (see Appendix 7) is
NOT considered a suitable and safe candidate for IVMS and the IVMS nurse
should NOT proceed. The electrophysiologist in charge of the case should be
informed immediately. The patient should be referred to an anaesthetist. If a patient
fails to meet the criteria and the case is either an emergency or on-call case the
anaesthetic coordinator should be contacted for advice. If in hours and an elective
case the consultant anaesthetists linked to the department should be contacted.
1.9 No patient shall be administered sedation or opioid agents if they have not achieved
the minimum fasting period set out in appendix 8.
2. Pre-procedure Equipment and Drug Preparation.
2.1 The IVMS nurse will ensure that all equipment needed in the EP cath labs is checked and
in good working order (see Protocol, Standard and Competency for Nurse
Administration of IV Moderate Sedation in Combination with Local Anaesthesia) -
this process must be carried out prior to the start of an EP list and according to the
normal Safer Surgery checklist.
2.2 Opioid and benzodiazepine drugs are to be administered as prescribed on the patients
IVMS chart prior to the procedure, and administered as per BLT controlled drugs
policy (BLT/POL/RIT/00004/DITSS).
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2.3 Drugs listed on the Patient Group Directive must be administered as per PGD policy.
2.4 All IVMS drugs must be checked, prepared and disposed of as per trust policy
regarding controlled drugs (BLT/POL/13561/NQA)
3. Procedural Patient Care
Introduction: IVMS nurses must be able to -
accept responsiblity for patients receiving sedation and/or analgesic agents
demonstrate a full and in-depth understanding of the pharmacology of these drugs, as
well as the role of pharmacologic antagonists for opioids and benzodiazepines.
Demonstrate correct and safe monitoring patients receiving IVMS drugs, and be
capable of prescribing and providing safe and effective recovery / discharge into the
care of receiving / escorting ward nurses
recognize the complications associated with the use of IVMS drugs and reversal
agents.
be capable of establishing a patent airway, using simple and available equipment that
they have been trained and assessed on. It is essential that IVMS nurse are qualified
to administer intermediate life support.
3.1 A senior/ consultant electophysiologist will be in attendance to provide supervision
and support to the IVMS nurse.
3.2 When cases are undertaken within the department it is essential that a member of staff
is a qualified Advance Life Support provider.
3.3 The IVMS nurse administering sedation and analgesia will not have any other role
for the duration of the procedure: this is a requirement of The Royal College of
Anaesthetists, The Royal College of Radiologists (via The Intecollegiate Working
Party chaired by the Royal College of Anaesthetists (2001)); and The American
Society of Anaesthesiologists.
3.4 Monitoring of patient response to verbal commands must be routine during the
Procedure. Appropriate verbal response to oral commands/ light stimulation
indicates the patient is be able to control their own airway.
3.5 A response limited to reflex withdrawal from a painful stimulus is not a purposeful
response for a patient under moderate sedation, and indicates the patient is too heavily
sedated (see above definition of moderate and deep sedation). In this instance all
administration of IVMS agents should stop, and administration of reversal agents as
well as airway management be considered. If required, help should be requested from
(firstly) the EP operator, then (secondly) the anaesthetic co-ordinator or an available
anaesthetist associated with the department. This requires an in-depth understanding
of activating the emergency calls according to BLT policy
3.6 During procedures, the following non invasive monitoring must be performed and
recorded on the patients sedation chart:
Continuous electrocardiographic monitoring
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Continuous heart rate monitoring to be recorded at intervals of at least fifteen
minutes.
Continuous pulse oximetery monitoring to be recorded at intervals of at least
fifteen minutes.
Continuous non invasive blood pressure monitoring to be recorded at intervals
of at least fifteen minutes.
Continuous respiratory rate monitoring is required for all patients, or for any
patients who are having procedures where drapes will cover their chest and
face so making monitoring of respiration more difficult by other methods.
If any abnormalities occur during the procedure then these will be recorded on the
patient‟s sedation chart as a variance.
3.7 Drugs and intravenous fluids will be administered as per the policy for the patient
group directions for electrophysiology and should not exceed the maximum
dosage set out by Consultant anaesthetists linked to the department.
See Appendix 2 & 9.
3.8 Upon patient assessment, and if not contraindicated by the patient‟s current
medical condition, a maintenance fluid of either 0.9% sodium chloride or
gelofusine (colloid solution) should be administered by infusion (on prescription), and
the total amount given documented on the patient‟s sedation chart. See Appendix 8
3.9 If fluid administration is contra-indicated due to the patients current condition,
the fluid should still be connected to the patient for emergency use. It should be
turned off during the procedure, and removed once in recovery. Any fluid
administered will be documented.
3.10 Equipment to administer supplemental oxygen must be used when sedation and
opioid agents are administered. All patients must be given supplemental oxygen
during any procedure requiring sedation and in the immediate recovery period. This
will aid in the prevention of hypoxia, and protect against the effects of
hypoventilation and respiratory depression.
3.11 In the event that the agents being administered reaching the maximum level set
by the anaesthetic consultants (see Appendix 8 & 9), the consultant/ senior
electrophysiologist shall be informed.
3.12 If the maximum level of opioid and sedation agents has been reached, and
the patient‟s condition requires further administration above the maximum
level, advice and patient review shall be sought from either the anaesthetic
coordinator (bleep 1220) or an available anaesthetist within the department.
Once reviewed, and if required, on approval of the anaesthetist the maximum
level of sedation and opioid agents to be administered can be increased to a
level not exceeding the safe administration level set by the consultant
anaesthetist linked to the department. The IVMS nurse will inform the
electrophysiologist of any actions taken. If an anaesthetist is not available the IVMS
nurse must not exceed the set limits (see Appendix 8 & 9).
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3.13 A table of Differential Diagnosis of complications during sedation can be found in
Appendix 10.
3.14 Any incidents during a procedure of concern to the IVMS nurse, or which may have
put the patient or staff caring for the patient at risk will be highlighted via a completed
of an incident form upon completion of the procedure. Any variance must also be
completed in the ICP
4. Post sedation procedure:
4.1 The IVMS nurse will remain with the patient during transfer to recovery and
provide a full hand over including components set out in Appendix 11.
4.2 This information will be documented in the patient‟s sedation chart and care
plan, for hand over to the ward nurse.
4.3 All opioid and sedation agents not administered will only be disposed of once the
patient has been transferred to the recovery unit. .
4.4 The disposal of drugs not administered will be done in accordance with the trusts‟
Controlled Drugs Procedure in the Electrophysiology Cath Labs (SBH).
(BLT/POL/RIT/00004/DITSS)
4.6 The patient will be recovered as per the policy for a general anaesthetic procedure.
5. Audit
5.1 It is already been initiated that the electronic database devised for EP reporting has an
IVMS record incorporated, and that the IVMS chart will be built into the ICP.
This is often completed by the operator, but will sometimes use the expertise of the
cardiac physiologist present (especially in pacing-related procedures). The original
copy of the IVMS chart will be retained with the ICP, and a photocopy version of this
chart will be retained for audit.
5.2 All IVMS nurses should participate in departmental monthly Morbidity and Mortality
meetings, presenting cases such as „near misses‟, critical incidents or simply
challenging or interesting cases - this provides a valuable opportunity for all
practitioners to improve their knowledge and so benefiting patient care and comfort.
This will also act as a forum for the group to air any concerns, if for example practice
elsewhere in the department is impacting on IVMS practice, and if necessary act to
address any issues as a group.
5.3 A lead/link nurse will be designated and in participation with the anaesthetic
department and the Matron / Cardiac Operations Manager for the invasive cardiology
department, co-ordinate all training and manage all issues associated with the
administration of IVMS.
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APPENDIX ONE
Competency Table for Nursing Sedation:
Criteria for competence Appraisee Name & Signature Appraiser Name & Signature Date
Demonstrates knowledge of pre-procedure preparation for
sedation
Demonstrates knowledge of assessing patient‟s airway prior
to sedation
Demonstrates safe physical and psychological assessment of
the patient pre procedure
Demonstrates knowledge of procedure to follow when a
patient does not fit the inclusion criteria
Demonstrates safe knowledge of the following high-risk co-
morbidities:
obesity
chronic obstructive pulmonary disease
coronary artery disease
renal failure
extremes of age
Demonstrates knowledge of correct prescribing and
administering of analgesia and sedative agents.
The sedation practitioner can define the following:
minimal sedation
moderate sedation
deep sedation
general anaesthesia
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Criteria for competence Appraisee Name & Signature Appraiser Name & Signature Date
Able to define and identify the differences between the 7
stages of the anaesthesia continuum:
local anaesthesia
minimal sedation
sedation
moderate sedation
deep sedation
anaesthesia
loss of protective reflexes
Demonstrates and in-depth awareness of the synergistic
effects of IV analgesic and sedation agents (e.g. the
interaction of these drugs and the effects on the patient).
Demonstrates knowledge of professional and legal issues and
accountability.
Demonstrates competency in the safe care of IV cannula in
patients.
Demonstrates adequate knowledge of the pharmacological
actions of benzodiazepines and opioids to achieve safe
moderate sedation.
Demonstrates adequate knowledge of the pharmacological
actions of the antagonists for opioids and benzodiazepines.
Demonstrates knowledge of the potential complications of
sedation and analgesia.
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Criteria for competence Appraisee Name & Signature Appraiser Name & Signature Date
Demonstrates adequate knowledge (incl. functions and
limitations) of the following monitoring:
Pulse oximetry
Non invasive blood pressure
ECG
Management of the airway and use of simple airway
manoeuvres‟ in the sedated adult patient
Demonstrates competency in assessing and establishing a
patent airway. Can demonstrate competence in the following
techniques, in establishing a patent airway using the
following
Head tilt, chin lift
Guedel airway
Nasopharyngeal airway
Demonstrates competency in the use of bag valve and mask
ventilation.
Demonstrates adequate knowledge of ALS algorithms
(including peri-arrest algorithms).
Demonstrates adequate knowledge of the different methods of
delivering supplementary oxygen to patients.
Demonstrates adequate knowledge of the principles of oxygen
uptake and transport.
Demonstrates the safe use of suction equipment.
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Criteria for competence Appraisee Name & Signature Appraiser Name & Signature Date
Demonstrates competency in monitoring the following:
Level of conscious sedation
Respiratory rate and pattern
Blood pressure and heart rate
Cardiac rhythm
Level of pain control
Patient perfusion
Demonstrates adequate knowledge of appropriate recording
of vital signs before and after drug administration, including
hydration.
Demonstrates adequate knowledge for assessing patient and
increasing the frequency of observing vital signs.
Demonstrates adequate knowledge of common cardiac
arrhythmias and their treatment.
Demonstrates the knowledge and competency to assess,
diagnose and initiate treatment in the event of the following
complications:
Respiratory Depression
Total airway obstruction
Aspiration
Hypotension
Anaphylaxis
Apnoeic episodes or apnoea
Hypoxia
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Criteria for competence Appraisee Name & Signature Appraiser Name & Signature Date
Demonstrates adequate knowledge of actions to be taken in
the event of sedation failure (e.g. paradoxical agitation).
Demonstrates adequate knowledge of information given to
patients post-procedure.
Demonstrates adequate knowledge and skill in pre sedation
patient assessment.
Demonstrates adequate knowledge of patient assessment post-
sedation.
Is conversant with EP department Guidelines, Standard and
Competency for Nurse Preparation & Administration of IV
Moderate Sedation in Combination with Local Anaesthesia.
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APPENDIX TWO - IVMS Drugs Dosage Protocol
Agent Max. single dose delivered by Sedation Practitioner
Onset and Duration Comments
Pethidine: 50mg/1mls Diluted up to 10mls to give a total strength of 5mg/ml
25mg-50mg IV 4 hourly. Give over 3-5 minutes3. Elderly- 25mg IV 4 hourly Max single dose: 25mg-50mg
Onset: 5 min Peak: 10-15 min Duration: 2-3 hours Active metabolite half Life: 24-48 hours
Respiratory: Potent respiratory depressant alone and when combined with benzodiazepines; skeletal muscle rigidity with rapid administration. Cardiovascular: Vagotonic producing bradycardia; Hypotension in hypovolaemic patients. Other: Avoid if creatinine clearance <10ml/min. Use with caution in patients with hypotension, hypothyroidism, asthma, history of convulsive disorders, raised intracranial pressure or head injury. Naloxone does not reverse pethidine induced seizures. Severe drug interactions may occur with monoamine oxidase inhibitors.
Diamorphine: 10mg diluted up to 2mls to give a total strength of 5mg/ml
1.25mg - 2.5mg IV; The dose may be increased according to individual needs. Max single dose: 2.5mg
Onset: I-3 min Peak: 10-20 min Duration: 3-4 hours Active metabolite half Life: active metabolites 3 hours
Respiratory: Potent respiratory depressant in the presence of other sedatives; in absence of pain may cause excessive sedation and dysphoria. Cardiovascular: Hypotension in hypovolaemic patients. Gastrointestinal: PONV, aspiration Other: CNS effect delayed up to 20mins. Careful consideration should be given before treating patients with myxoedema or hypothyroidism, adrenocortical insufficiency, toxic psychoses, CNS depression, prostatic hypertrophy or urethral stricture, kyphoscoliosis, acute alcoholism and delirium tremens, severe inflammatory bowel disease and severe diarrhoea.
Midazolam: 10mg/2mls Diluted up to 10mls to give a strength of 1mg/ml
2mg IV over 2min; may repeat at 5min intervals in increments of 0.5mg-1mg. Max single total Dose: 7.5mg
Onset: 1-2mins Peak: 10-12 mins Peak activity duration: 30-80 min Active metabolite half life: 1-4 hours
Respiratory: Central respiratory depressant and may produce apnoea, effects are pronounced. Cardiovascular: Can reduce MAPs, CO, SV and SVR. May also cause hypotension in hypovolaemic patients.
Diazemuls: 10mg/2mls
0.15-0.25 mg/kg (usually 10-20mg) by iv injection. No faster than 5mg/min Max single dose: 20mg
Onset: 1-5 min Peak: 15 min Peak activity duration: 15-30 min Parent drug half life: 1-3 days
Respiratory: Central respiratory depressant and may produce apnoea, effects are pronounced Cardiovascular: Hypotension in hypovolaemic patients.
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Agent Max. Dose delivered by Sedation Practitioner IV
Max. Dose of Drug IV
Onset and Duration Comments
Flumazenil: 500mcg/5ml Administer Undiluted
200mcg IV over 15sec then 100mcg at 60sec intervals if required. Total Dose:500mcg
1mg
Onset: 1-2mins Peak: 6-10mins Duration: 45-90min Half Life: 41-79min
Specific benzodiazepine antagonist; titrated to reverse respiratory depression and sedation. Duration of benzodiazepine exceeds duration of Flumazenil, continued assessment required. Can cause tachycardia and hypertension
Naloxone: 400mcg/ml Diluted up to 10mls to give a strength of 40mcg/ml
100mcg-200mcg IV over 30 secs then 100mcg every 2mins Total Dose: 400mcg
800mcg Onset: 2mins Peak: 5-15mins Duration: 30-5min Half Life: 30-60min
Opioid antagonist; titrate to achieve an acceptable respiratory rate; continued respiratory assessment essential. Can have a shorter duration than the opioid it is reversing, so continued assessment is required.
Ondansetron: 2mg/ml Administer undiluted
4mg IV over 2mins Total Dose: 4mg
12mg/24hrs
May cause headache, malaise, fatigue, constipation, diarrhoea and abdominal pain. No alteration of dose is needed in patients with renal impairment.
Normal Saline: 0.9%
500mls-1000mls IV over 3-6hrs Restrict intake in patients with impaired renal function. U&E’s should be checked prior to administration of fluids. Restrict intake in patients with cardiac failure. Best to use Normal saline for renal failure patients (no potassium unlike Hartmann’s) and diabetics (no lactate unlike Hartmann’s)
Agent Max. Dose delivered by Sedation Practitioner
Max. Dose of Drug
Onset and Duration Comments
Gelofusine:
500mls-1000mls IV, stat to 1hrs
Should be used with caution in patients with cardiac disease or renal impairment. Higher risk of severe allergic reactions than crystalloids. Should only be used in patients that become extremely hypotensive.
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Atropine: Administer Undiluted 600mcg/ml
300mcg -600mcg IV Bolus Repeated every 3-5mins Total Dose: 1mg
2mg Onset: 45-60secs Peak: 2mins Duration: 1-2hrs
Cardiovascular: Tachycardia is associated with high dosages CNS: Confusion, hallucinations These are very common in the elderly after the use of atropine.
Cyclizine: 50mg/ml Administer Undiluted
25mg-50mg IM Total Dose: 50mg IM
50mg/8hrs Onset: Peak: Duration:
Cardiovascular: The drug has a mild anticholinergic action and may produce a slight tachycardia CNS: The principal effect of the drug is an antiemetic effect with a slight degree of sedation.
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APPENDIX THREE – Cath Lab Safer Surgery Checklist Sign In – BY Radiographer
On Patient entry to Cath Lab TIME OUT – BY Scrub Nurse
Before Draping and Skin Incision SIGN OUT – BY Circulating Nurse / AHP
PRIOR TO SKIN CLOSURE AND PATIENT DISCHARGE FROM CATH LAB
Cath lab team confirms against Consent form and documentation: (with a scrub team member present) Would the patient / carer please verify:
Patient name, DOB, MRN
Patient’s known allergies / Not applicable
Planned procedure Indication/site appropriate (device patients)
Operator aware of Bloods results which includes HB, Platelets, U&Es and INR
Pre-procedure care plan / ICP is completed and satisfactory
Pregnancy excluded / not applicable ____________________________
Haemodynamic monitoring and other monitoring (e.g. ECG, blood pressure and pulse oximetry) is available
ECG’s reviewed
Previous radiological investigations available (e.g. Angiogram / CT scan)
EP / X-Ray equipment functioning.
Operator Appropriate anticoagulation / antithrombotic therapy given or not
(Cath Lab Team)
Confirmed with operator that all essential imaging are available and correct / Not applicable
*All required ancillary services are available / Not applicable e.g. anaesthetist / surgeon
All essential instrument trays / devices are available and substitutions acceptable
Sign in checks are now completed * Ancillary defined as additional to Cath lab team
TEAM STOPS. Cath lab team confirms
*Can all team members introduce their name and role to each other and patient?
_______________________________________ Please confirm with consent form, essential imaging and patient band that we have:
Correct patient (name, DOB, MRN)
Correct procedure
Correct site and positioning
(to Operator)
What critical steps / problems do we anticipate during the procedure and need to prepare for?
Are all essential instruments / devices available and sterility confirmed?
________________________________________ (to cath lab team)
Has antibiotic prophylaxis been administered as per protocol / not applicable
Hair removal appropriate / not applicable
Glycaemic control / Blood sugar recorded if applicable
Are there any other concerns? _________________________________________
Time Out checks are now completed and we can proceed with procedure * Introduction for the first case on a list only or if team members change
Cath lab team confirms: (To First operator)
Please confirm the procedure performed
(to scrub nurse)
Is the count for instruments, swabs (Implant patients only) and sharps correct?
Are there any equipment problems to be addressed?
If a specimen is produced, please confirm it is labelled with correct patient & site, specimen type and how it is to be sent.
____________________________________ (to everyone)
Are there any concerns for recovery and management of this patient
Specific post procedure instructions given such as medication(anticoagulation therapy) and vascular access site
Recovery area is ready for patient and an oxygen cylinder is available for transfer if applicable __________________________________
Sign out is now completed Thank You To record completion of this checklist: Sticker 1 must be stuck onto the front of the Peri-op Care plan / checklist Sticker 2 must be stuck into the Cath Lab log book, with any issues documented
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APPENDIX FOUR
Components of Pre-sedation Patient Assessment:
Patient Age, height and weight
Proposed procedure
Name of sedation practitioner and electrophsyiologist performing the procedure.
Baseline observations. (Patients whom you may be concerned about saturations
should be checked on air or on the amount of oxygen they are on prior to sedation.
Note: No patients requiring more than 5l/min via nasal cannula oxygen should be
sedated.)
When undertaking a history direct from the patient or indirect from the patient‟s
notes the following should be determined, and a summary documented on the
sedation chart.
Cardiac History:
Hypertension/Hypotension
Coronary Artery Disease
Angina
Myocardial Infarction
Cardiac Dysrhythmias
Presence of Pacemaker
Respiratory System:
Shortness of Breath
Asthma
COPD
Bronchitis
Smoking history
Renal System:
Renal insufficiency
Renal failure
Dialysis
Endocrine System:
Diabetes
Hyper/Hypothyroidism
Adrenal Disease
Gastrointestinal System:
Nausea
Vomiting
Recent Weight Loss
Gastric Reflux
Neurological System:
Stroke
History of fits.
Headaches
Haematology
Anaemia
Aspirin & NSAID use
Clopidrogrel / Warfarin use
Heparin infusions
Excessive bleeding
History of past procedures
Anaesthesia complications
History of post operative nausea and
vomiting
Any family history of problems with
anaesthesia
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As well as a surgical and medical history the following information should be obtained
either direct or indirect:
Medication:
Names
Dosages
Patient compliance
Any side effects
Allergies:
To what
What symptoms of allergy were
encountered?
Laboratory Data:
FBC
U & E‟s
INR
ATTP
Dentition:
Capped teeth
Loose/chipped teeth
Dentures
Social History:
Tobacco Use
Alcohol Use
Illicit Drug use
Herbal use
Possibility of Pregnancy
ASA Physical Status Classification:
ASA Risk 1-3
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APPENDIX FIVE
American Society of Anaesthesiologists (ASA) Classification of Physical Status
The American Society of Anaesthesiologists (ASA) Classification of Physical Status is
as follows:
ASA ONE (I)
Normal, healthy patient with no systemic disease
Example:
Patients health: Excellent with no systemic disease
Limitations on activity: None
Danger of Death: None
Excluded: Persons at extremes of age
ASA Two (II)
Mild to moderate systemic disease
Example:
Patients health: Disease to one body system
Status of underlying disease: well controlled
Limitations on activity: Well controlled
Danger of Death: None
ASA Three (III)
Sever systemic disease with functional limitation that is not incapacitating
Example:
Patients health: Disease of more than one body system or one major system to one
body system.
Status of underlying disease: Controlled
Limitations on activity: Present but not incapacitating
Danger of Death: No immediate danger
ASA Four (IV)
Sever systemic disease that is incapacitating and life threatening
Example:
Patients health: Poor with at least one severe disease
Status of underlying disease: Poorly controlled or end stage
Limitations on activity: Incapacitated
Danger of Death: Possible
ASA Five (V)
A moribund patient not expected to survive 24 hours without surgical
intervention.
Example:
Patients health: Very Poor, moribund
Limitations on activity: Incapacitated
Danger of Death: Imminent
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APPENDIX SIX
Assessment of patient airway.
The American Society of Anaesthesiologists Task Force on Management of the
Difficult Airway created practice guidelines for management of the difficult airway.
The guidelines were published in Anesthesiology, 78(3), March, 1993.
The guidelines call for preoperative history and physical examination, preoperative
preparation of equipment and pre formulated strategy.
Evaluation of the airway must include a history and physical examination. Whenever
feasible an airway history should be obtained. History of congenital, acquired or
traumatic disease affecting the airway can indicate difficulty. History of past
anaesthetics and anaesthetic records may yield valuable information.
Whenever feasible, an airway physical examination should be conducted. Specific
features of the head and neck may suggest difficulty. (See Appendix 5)
Anyone with a difficult airway should be discussed with an anaesthetist before
proceeding further. Assessment of Airway:
Patients that undergo sedation and opioid administration should undergo a focused
assessment of their airway including auscultation of the heart and lungs.
Areas of assessment should include:
Oral Cavity inspection
Temporomandibular Joint Examination – to show mouth opening ability
Neck extension
Physical Characteristics on observations e.g. receding chin, diverted trachea, large
tongue, short thick neck, protruding teeth, malignancy around the neck or in the
airway and high arched palate.
The practitioner should undertake the following:
Note factors that may make mask ventilation difficult, such as the presence of a
beard.
Carefully assess mouth opening. An opening of at least two large finger breadths
between the upper and lower incisors in the adult is desirable.
The presence of loose teeth or protruding upper teeth, a high-arched palate or a long
narrow mouth, and temporomandibular joint problems may predispose to difficulty.
The neck should be examined for masses, mobility, and deviation of the trachea.
The presence of a hoarse voice, stridor or previous tracheotomy should alert the
practitioner to possible stenosis at some level.
Mallampati Airway classification.
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The Mallampati classification relates tongue size to pharyngeal size. This test is
performed with the patient in the sitting position, the head held in a neutral position, the
mouth wide open, and the tongue protruding to the maximum. The subsequent
classification is assigned based upon the pharyngeal structures that are visible.
Class I = visualization of the soft palate, fauces, uvula, anterior and posterior pillars.
Class II = visualization of the soft palate, fauces and uvula.
Class III = visualization of the soft palate and the base of the uvula.
Class IV = soft palate is not visible at all.
Atlanto-occipital movement – Neck extension. Additionally limited Atlanto
occipital joint extension is present in certain pathological states such as
spondylosis, rheumatoid arthritis, and any history of head and neck malignancy
or previous radiotherapy. All of these conditions should point to problems with
neck extension.
[Type text] [Type text] Martin Moon 2010
APPENDIX SEVEN
Patients that should not undergo nurse administration of
IVMS:
If after assessment the patient has any of the following conditions they should not be
sedated by an IVMS nurse, and advice should be sought from the electrophysiologist. A
review should take place with both the anaesthetist and the electrophysiologist to have
the case rebooked on to a list covered by an anaesthetist.
Any patient who is pregnant
Any patient from a critical care environment requiring organ support e.g. ITU or
HDU
Patients with acute cardiac conditions
Conditions include:
Acute Coronary Syndrome
Uncontrolled cardiac dysrhthmias
Uncontrolled tachycardia or bradycardia
Patients with acute respiratory conditions
Conditions include:
Acute on chronic obstructive pulmonary disease
Continuous positive airway pressure
Biphasic positive airways pressure
Fractional inspired oxygen content > 40% to maintain saturations
Obstructive Sleep Apnea
Patients with an American Society of Anaesthesiologists (ASA) score of 4 or 5 (see
appendix 4) Definitions include:
ASA Four (IV)
Severe systemic disease that is incapacitating and life threatening
Example:
Patients health: Poor with at least one severe disease
Status of underlying disease: Poorly controlled or end stage
Limitations on activity: Incapacitated
Danger of Death: Possible
ASA Five (V)
A moribund patient not expected to survive 24 hours without surgical
intervention.
Example:
Patients health: Very Poor, moribund
Limitations on activity: Incapacitated
Danger of Death: Imminent
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APPENDIX EIGHT
Fasting Guide Lines
Taken form Bart’s and the London NSH Trust Policy for Nil by mouth for adult
patients BLT/POL/ANA/00018/CSS
Nil By Mouth Fasting Guidelines:
Ingested material Minimum Fasting Period
Clear Liquids (Water) 2hrs
Non clear fluids (non milk) 4hrs
Food including milk products 6hrs
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APPENDIX NINE
National Patient Safety Association Report:
Rapid Response Report: NPSA/2008/RRR011: (title) Reducing risk of overdose with midazolam injection in adults
NOTE:
Midazolam - dosing in conscious sedation:
In adults, the intravenous injection of midazolam should be given slowly at a rate of
approximately 1 mg in 30 seconds.
In adults below the age of 60 the initial dose is 2 to 2.5mg given five to 10 minutes
before the beginning of the procedure. Further doses of 1mg may be given as
necessary. Mean total doses have been found to range from 3.5 to 7.5mg. A total dose
greater than 5mg is usually not necessary.
In adults over 60 years of age, debilitated or chronically ill patients, the initial dose
must be reduced to 0.5-1.0mg and given five to 10 minutes before the beginning of the
procedure. Further doses of 0.5 to 1mg may be given as necessary. Since in these
patients the peak effect may be reached less rapidly, additional midazolam should be
titrated very slowly and carefully. A total dose greater than 3.5mg is usually not
necessary.
(reference - supporting information (National Patient Safety Agency, National
Reporting and Learning Service): 9th
December, 2009)
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APPENDIX TEN
Differential Diagnosis of Complications During IVMS:
(see also “Angio Recovery Checklist”)
Restlessness:
Hypoxemia
Pain
Hypotension
Bladder distension
Emotional Response
Shivering
Hypercarbia
Gastrointestinal distress/distension
Psychotropic effects of sedation
Disorientation after deep sedation
Dysrhythmias:
Pain
Hypoxemia
Procedural myocardial infarction
Metabolic changes ie
hypo/hyperkalaemia
Pre-existing disease
Hypercarbia from respiratory
depression
Failure of artificial pacemaker
Side effects of sedative/opioid
Electrolyte imbalance
Hypotension:
Hypovolemia
Dehydration
Excessive bleeding
Peripheral vasodilation e.g. sepsis,
anaphylaxis.
Effect of sedation
Decreased myocardial contractility
e.g. Myocardial ischemia or
dysrhythmias
Tachycardia:
Pain
Hypovolemia
Fever
Sepsis
Hyperthyroidism
Effect of medication (atropine)
Hypertension:
Pain
Hypoxemia
Bladder distension
Shivering, vasoconstriction
Hypercarbia
Vomiting
Fluid overload
Effects of medication (naloxone,
ephedrine, epinephrine)
Bradycardia:
Sedative/opioid drugs
Oculocardiac reflex: A decrease in
pulse rate associated with traction
applied to extraocular muscles and/or
compression of the eyeball.
Stimulation– such as sudden pain,
visceral stretch or carotid massage
Hypoventilation
Myocardial ischemia
Respiratory Depression:
Obstructed airway
Relative overdose of sedation
Splinting of the diaphragm, secondary
to pain, or position
Pulmonary congestion (heart failure)
Positioning
COPD and pre-existing disease
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APPENDIX ELEVEN
Components of Post sedation handover
Patients name
Age
Procedure
Allergies
Presedation Observations
Level of Consciousness
Airway status
Amount of Oxygen administered
Sedation/opioids administered
Total doses of drugs administered
Any reversals administered, and time reversal given
Response to medication
Fluid administered and fluid balance
Post procedure instructions / plan
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APPENDIX TWELVE
Individual Authorisation
THIS PROTOCOL DOES NOT REMOVE INHERENT PROFESSIONAL OBLIGATIONS OR ACCOUNTABILITY.
It is the responsibility of each professional to practice only within the bounds of their
own competence and in accordance with their own Code of Professional Conduct.
Note to Authorising Assessors: authorised staff should be provided with an individual copy of the clinical content of this protocol and a photocopy of the document showing their authorisation. A copy of the authorisation shall also be retained by the Lead Nurse / Allied Health Professional and one sent to the Director of Clinical Pharmacy. I (Name and Department)___________________________________________ have undertaken a training programme, including competency assessment for the Administration of the combination of drugs named above, according to the PROTOCOL,
STANDARD AND COMPETENCY FOR NURSE ADMINISTRATION OF IV MODERATE
SEDATION IN COMBINATION WITH LOCAL ANAESTHESIA
I have been assessed as competent to undertake this role, have met, and accept the following minimum criteria:
1) am Trust IV certificated 2) have completed the Trust Basic Life Support (minimum), manual defibrillation,
and Rhythm Recognition courses 3) have been qualified for a minimum of 2 years as a registered nurse 4) am able to demonstrate the ability to coordinate a lab unsupervised 5) can demonstrate an in-depth understanding of IVMS associated accountability
and responsibility issues 6) am willing to accept, via signing this, inherent professional and accountability
obligations. Assessor’s signature ____________________________________ Print Name ____________________________________ Role ____________________________________ I have ensured that my name has been added to the Departmental record of accredited nurses/pharmacists. Signed ____________________________________ Print Name ____________________________________ Date ____________________________________
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