BARTS AND THE LONDON NHS TRUST - BMJ

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)

[Type text] [Type text] Martin Moon 2010

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


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.


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.


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


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).


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


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).


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.


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



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.



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.



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



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.


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.


Agent Max. Dose delivered by Sedation Practitioner IV

Max. Dose of Drug IV


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


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.


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.


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


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


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


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


Danger of Death: Imminent


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.


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.


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


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


Danger of Death: Imminent


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


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)


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

http://en.wikipedia.org/wiki/Pulse_rate

http://en.wikipedia.org/wiki/Traction

http://en.wikipedia.org/wiki/Extraocular_muscles

http://en.wikipedia.org/wiki/Eyeball


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


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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