ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12620001045909

Ethics application status

Approved

Date submitted

18/07/2020

Date registered

15/10/2020

Date last updated

15/10/2020

Date data sharing statement initially provided

15/10/2020

Type of registration

Retrospectively registered

Titles & IDs

Public title

Muscle Relaxation and Endotracheal Intubation: Textbook or Evidence Based? (Relaxed Study)

Scientific title

Observational study to investigate the degree of muscle relaxation at the time of endotracheal intubation after a routine anaesthetic induction in adult patients scheduled for elective surgery: textbook or evidence based? (Relaxed Study)

Secondary ID [1]

None

Universal Trial Number (UTN)

U1111-1255-6777

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

muscle paralysis for intubation

Condition category

Condition code

Anaesthesiology

Anaesthetics

Surgery

Other surgery

Intervention/exposure

Study type

Observational

Patient registry

False

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

When neuromuscular monitoring is used, ‘optimal’ intubating conditions for laryngoscopy and endotracheal intubation (ETI) are indicated by the disappearance of the Train-of-Four Count (TOFC=0) measured by a digital peripheral nerve stimulator (PNS); if intubated prior to this point, i.e., TOFC=0, such intubation condition is defined as "suboptimal".
Prior to anaesthetic induction, a quantitative PNS (TOFscan, IDMED, France) will be applied to the patient’s ulnar nerve at the wrist for the purpose of adductor pollicis muscle stimulation. The non-depolarising neuromuscular blocking agent (NDNMBA), dosage and the time to attempt ETI after drug administration will remain at the Anesthetist’s discretion. At the time of ETI, TOF stimulation is activated and auto TOF will repeat every 30 seconds. If the Anesthetist would elect to use neuromuscular monitoring as part of their usual practice, the TOF results will not be blinded.
All time-points with TOF-ratio (TOFR) and TOFC will be recorded on site into a standardised data collection sheet until the TOFC reaches '0' or 30 minutes after NDNMBA administration, whichever comes first, at which point data collection will be ceased.

Intervention code [1]

Not applicable

Comparator / control treatment

no control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

To establish the prevalence of endotracheal intubations (ETI) attempted under ‘suboptimal’ conditions in routine Anaesthetic practice:
1. When neuromuscular monitoring is used, ‘optimal’ intubating conditions are indicated by the disappearance of the Train-of-Four Count (TOFC=0) measured by a quantitive peripheral nerve stimulator (PNS); if intubated prior to this point, i.e., TOFC=0, such intubation condition is defined as "suboptimal".
2. All time-points with TOF-ratio (TOFR) and TOFC will be recorded into a standardised data collection sheet at the time.
3. The prevalence of 'suboptimal' intubation will be calculated as the percentage of patients who are intubated prior to the disappearance of TOF, i.e., TOFC=0

Timepoint [1]

within 30 minutes after administering a standard dose of NDNMBAs:
# the PNS will be applied to the patient's wrist just before anaesthetic induction, it will be activated upon ETI, data will be collected until the TOFC reaches '0' or 30 minutes after NDNMBA administration, whichever comes first, at which point data collection will be ceased.

Secondary outcome [1]

To determine the time needed after a standard dose of NDNMBAs to reach an optimal muscle paralysis for intubation, indicated by the disappearance of TOFC (TOFC=0) on a quantitive PNS:
All time-points with TOF-ratio (TOFR) and TOFC will be recorded on site into a standardised data collection sheet until the TOFC reaches '0' or 30 minutes after NDNMBA administration, whichever comes first, at which point data collection will be ceased. Of note, the time taken for TOFC to reach "0" is the duration from NDNMBA administration to "no twitch out of the four twitches" (Train-of-Four mode) shown on the PNS.
The time (seconds) taken for TOFC to reach "0" from the time of NDNMBA administration will be entered into a spreadsheet.
These time periods will be averaged with a 95% confidence interval (CI), which is the time needed after a standard dose of NDNMBAs to reach an optimal muscle paralysis for intubation

Timepoint [1]

Secondary outcome [2]

The number of patients whose TOFC never reach "0" will be counted and calculate as percentage of all participants.

Timepoint [2]

A duration of 30 minutes, starting from NDNMBA administration for 30 minutes.

Eligibility

Key inclusion criteria

adult patients scheduled for elective surgery at our hospital with an Anaesthetic management plan of endotracheal intubation facilitated by use of a NDNMBA

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

patient refusal
younger than 18 years old
language barrier
dementia or intellectual disability

Study design

Purpose

Natural history

Duration

Cross-sectional

Selection

Defined population

Timing

Prospective

Statistical methods / analysis

descriptive statistics used

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

Actual

4/02/2019

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

100

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Maroondah Hospital - Ringwood East

Recruitment postcode(s) [1]

3135 - Ringwood East

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Maroondah Hospital

Address [1]

1-15 Davey Drive
East Ringwood
VIC 3135

Country [1]

Australia

Primary sponsor type

Individual

Name

Dr Aihua Wu

Address

Department of Anaesthesia
Maroondah Hospital
1-15 Davey Drive
East Ringwood
VIC 3135

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Eastern Health Human Research Ethics Committee

Ethics committee address [1]

Level 2
5 Arnold Street
Box Hill 
VIC 3128

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

29/11/2016

Approval date [1]

06/12/2016

Ethics approval number [1]

Summary

Brief summary

When patients undergo surgery with general anaesthesia, the anaesthetist places a plastic tube into the windpipe after the patient is put into sleep. At this time, deep muscle relaxation is required to prevent some bad reflex responses to this procedure, such as coughing and bulking on the tube.
However, in daily practice it is not practical to monitor every patient so closely who receives the muscle relaxant drugs, especially during the anaesthetic induction period when the tube is placed into the windpipe after patient is anaesthetized, as this is the most intense and stressful period for the anaesthetist. As such, a majority of anaesthetists routinely use the standard dose of the relaxant drugs and place the tube into the windpipe at the set time point according to the drugs’ respective “product information”.
Such practice works for most patients, but some patients may have different sensitivity to the muscle relaxant drugs, and thus it may take longer time than normal to have deep muscle relaxation. This time lag may result in the tube being placed into the windpipe too early and thus cause some unwanted body reactions. These reactions may be very bad for certain patients, for example, if the patient has existing high blood pressure.
In order to prevent such premature placement of the windpipe tube, we need to first find out how bad the problem is, i.e., how prevalent the premature placement of the windpipe tube is during standard anaesthetics induction, this is measured by a digital peripheral nerve stimulator, quantifying the degree of muscle relaxation. The good time to place the tube into the windpipe is when none of the four twitches appear on Train-Of-Four (TOF) stimulation of a nerve stimulator, applied to the patient's wrist before anaesthesia. 
The prevalence of premature placement of the windpipe tube is determined by the percentage of patients whose tube is placed before the disappearance of TOF on the nerve stimulator.
This is what our study aims to do and only after we have determined the problem's prevalence, we will then be able to make recommendations accordingly so that we can modify and improve our patient care.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Aihua Wu

Address

Department of Anaesthesia and Pain Management
Maroondah Hospital
1-15 Davey Drive
Ringwood East
VIC 3135

Country

Australia

Phone

+61398713448

Fax

aihua.wu@easternhealth.org.au

Contact person for public queries

Name

Aihua Wu

Address

Department of Anaesthesia and Pain Management
Maroondah Hospital
1-15 Davey Drive
Ringwood East
VIC 3135

Country

Australia

Phone

+61398713448

Fax

aihua.wu@easternhealth.org.au

Contact person for scientific queries

Name

Aihua Wu

Address

Department of Anaesthesia and Pain Management
Maroondah Hospital
1-15 Davey Drive
Ringwood East
VIC 3135

Country

Australia

Phone

+61398713448

Fax

aihua.wu@easternhealth.org.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

Yes

What data in particular will be shared?

All of the individual participant data collected during the trial, which are de-identified.

When will data be available (start and end dates)?

Immediately following publication. No end date.

Available to whom?

Anyone who wishes to access the data.

Available for what types of analyses?

Any purpose.

How or where can data be obtained?

Data are available indefinitely by emailing the principal investigator Dr Aihua Wu at aihua.wu@easternhealth.org.au

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
8536	Informed consent form			aihua.wu@easternhealth.org.au		380221-(Uploaded-18-07-2020-10-17-07)-Study-related document.docx
8537	Ethical approval			aihua.wu@easternhealth.org.au		380221-(Uploaded-18-07-2020-10-17-50)-Study-related document.pdf

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

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