Trial Review

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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] 301818 0
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 318612 0
Condition category
Condition code
Anaesthesiology 316305 316305 0 0
Anaesthetics
Surgery 316631 316631 0 0
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] 318117 0
Not applicable
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 324478 0
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] 324478 0
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] 384771 0
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] 384771 0
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 [2] 387000 0
The number of patients whose TOFC never reach "0" will be counted and calculate as percentage of all participants.
Timepoint [2] 387000 0
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?
No
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
78
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 17114 0
Maroondah Hospital - Ringwood East
Recruitment postcode(s) [1] 30790 0
3135 - Ringwood East

Funding & Sponsors
Funding source category [1] 306245 0
Hospital
Name [1] 306245 0
Maroondah Hospital
Country [1] 306245 0
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] 306730 0
None
Name [1] 306730 0
Address [1] 306730 0
Country [1] 306730 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306455 0
Eastern Health Human Research Ethics Committee
Ethics committee address [1] 306455 0
Level 2
5 Arnold Street
Box Hill
VIC 3128
Ethics committee country [1] 306455 0
Australia
Date submitted for ethics approval [1] 306455 0
29/11/2016
Approval date [1] 306455 0
06/12/2016
Ethics approval number [1] 306455 0

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 103942 0
Dr Aihua Wu
Address 103942 0
Department of Anaesthesia and Pain Management
Maroondah Hospital
1-15 Davey Drive
Ringwood East
VIC 3135
Country 103942 0
Australia
Phone 103942 0
+61398713448
Fax 103942 0
Email 103942 0
aihua.wu@easternhealth.org.au
Contact person for public queries
Name 103943 0
Dr Aihua Wu
Address 103943 0
Department of Anaesthesia and Pain Management
Maroondah Hospital
1-15 Davey Drive
Ringwood East
VIC 3135
Country 103943 0
Australia
Phone 103943 0
+61398713448
Fax 103943 0
Email 103943 0
aihua.wu@easternhealth.org.au
Contact person for scientific queries
Name 103944 0
Dr Aihua Wu
Address 103944 0
Department of Anaesthesia and Pain Management
Maroondah Hospital
1-15 Davey Drive
Ringwood East
VIC 3135
Country 103944 0
Australia
Phone 103944 0
+61398713448
Fax 103944 0
Email 103944 0
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.TypeCitationLinkEmailOther DetailsAttachment
8536Informed consent form  aihua.wu@easternhealth.org.au 380221-(Uploaded-18-07-2020-10-17-07)-Study-related document.docx
8537Ethical 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.