Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618002039268
Ethics application status
Approved
Date submitted
3/12/2018
Date registered
20/12/2018
Date last updated
20/12/2018
Date data sharing statement initially provided
20/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Neuromuscular function monitoring to assess patient recovery from muscles relaxants.
Scientific title
Comparison of two electromyographic devices to assess recovery from neuromuscular blockade (muscle relaxants) in patients undergoing general anaesthesia in the operating theatre.
Secondary ID [1] 296766 0
Nil Known
Universal Trial Number (UTN)
U1111-1224-9080
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Residual Neuromuscular Blockade 310652 0
Medication (Neuromuscular Blockade) Monitoring 310653 0
Respiratory Failure 310654 0
Aspiration of Gastric Contents 310655 0
Condition category
Condition code
Anaesthesiology 309365 309365 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1: Tetragraph Comparison in Different Muscles to Determine the Most Precise and Accurate muscle.
Objective: 1. To compare the precision and accuracy of the Tetragraph at the abductor digiti minimi (ADM), the adductor policis (AP), and the first dorsal interosseous (FDI) and the flexor hallucis brevis (FHB) muscles under general anaesthesia, during spontaneous recovery from non-depolarising neuromuscular blockade.
Materials and Procedures: Tetragraph (Acacia Designs BV, Amsterdam, Holland) is a novel EMG-based monitor that has advantages over older monitors. Availability as a stand-alone unit, with improved electrode design and surface contact. TetraSens electrodes will be utilised. There is 1 TetraSens electrode per Tetragraph. It analyses amplitude of acquired compound muscle action potentials. Written consent will be obtained from participants. Quantitative neuromuscular function monitoring is the highest standard of care and is recommended as routine by the College of Anaesthetists. There are no known risks of this monitoring.
Randomisation – 1. The side each respective muscle (ADM vs FDI) will be allocated.
Participants will be connected to two Tetragraphs, one one on either arm, with TetraSens electrodes. Each Tetragraph will be connected to a different muscle -ADM, FDI, AP, FHB depending on randomisation.
Who Delivers Intervention: A Junior Doctor.
Mode of Delivery: Face to Face
Number of Times: Once - duration is length of surgery. Arm 1 will be undertaken for a minimum of a month before Arm 2 will be commenced.
Location: Private Hospital
Definition of the most precise and accurate muscle: Bland–Altman analysis for repeated Train Of Four measurements at hand and foot muscles will be used to determine the repeatability coefficient (precision), bias (accuracy), and limits of agreement (accuracy) at each level of recovery, divided into TOF bands. The repeatability coefficient evaluates the precision of a measurement method. A small repeatability coefficient represents high precision. Bias and limits of agreement assess agreement (accuracy) between two measurement methods. A small bias with narrow limits of agreement represents a high degree of agreement and interchangeability.
Participants will undertake Arm 1 independently of Arm 2, depending on the time of enrolment.

Arm 2: Comparison of two EMG monitors utilising the most precise and accurate muscle found in Arm 1.
Objective: 2. To investigate the precision and accuracy between the Tetragraph and the NMT Electrosensor, using the train of four (TOF) stimulation of the ulnar nerve under general anaesthesia, during spontaneous recovery from non-depolarising neuromuscular blockade.
Materials and Procedures: Tetragraph (Acacia Designs BV, Amsterdam, Holland) is a novel EMG-based monitor that has advantages over older monitors. Availability as a stand-alone unit, with improved electrode design and surface contact. TetraSens electrodes will be utilised. It analyses amplitude of acquired compound muscle action potentials. NMT Electrosensor (GE Healthcare, Helsinki, Finland is currently the most widely available EMG monitor. Use is limited by the requirement to connect to an expensive monitor designed specifically for its use alone, and analyses the area under the curve (AUC).
Written consent will be obtained from participants. Quantitative neuromuscular function monitoring is the highest standard of care and is recommended as routine by the College of Anaesthetists. There are no known risks of this monitoring.
Randomisation – 1. The side each respective muscle (ADM vs FDI) will be allocated.
The Tetragraph will be connected with TetraSens to one muscle (the most precise and accurate found in Arm 1), and the GE NMT electrosensor will be connected on the other hand with ECG electrodes in the same muscle.
Who Delivers Intervention: A Junior Doctor.
Mode of Delivery: Face to Face
Number of Times: Once - duration is length of surgery. Arm 1 will be undertaken for a minimum of a month before Arm 2 will be commenced.
Location: Private Hospital
Participants will undertake Arm 2 independently of Arm 1, depending on the time of enrolment.
Intervention code [1] 313076 0
Prevention
Intervention code [2] 313077 0
Treatment: Devices
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 308320 0
Precision (Repeatability) of a comparison of the different muscles including ADM, FDI, AP, and FHB measured by Tetragraph.
Timepoint [1] 308320 0
Baseline, approximately 1-3 hours (length of surgery)(Primary end point), repeated over 10 weeks approximately 10-20 times weekly.
Primary outcome [2] 308460 0
Accuracy (bias and limits of agreement) of a comparison of the different muscles including ADM, FDI, AP, and FHB measured by Tetragraph
Timepoint [2] 308460 0
Baseline, approximately 1-3 hours (length of surgery)(Primary end point), repeated over 10 weeks approximately 10-20 times weekly.
Secondary outcome [1] 354606 0
Precision (Repeatability) between each monitoring method, Telegraph and GE Healthcare NMT Electrosensor, readings utilising the EMG tools. This will help determine whether the two methods, as well as the accepted post-operative EMG TOF ranges, are interchangeable.
Timepoint [1] 354606 0
Baseline, approximately 1-3 hours (length of surgery)(Primary end point), repeated over 10 weeks approximately 10-20 times weekly.
Secondary outcome [2] 355001 0
Accuracy between each monitoring method, Telegraph and GE Healthcare NMT Electrosensor, readings utilising the EMG tools. This will help determine whether the two methods, as well as the accepted post-operative EMG TOF ranges, are interchangeable.
Timepoint [2] 355001 0
Baseline, approximately 1-3 hours (length of surgery)(Primary end point), repeated over 10 weeks approximately 10-20 times weekly.

Eligibility
Key inclusion criteria
Inclusion criteria - 18 years of age, receive neuromuscular blocking agent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria – previous procedures or pre-existing condition where TOF ratio may not be measure accurately, allergy to adhesive gel electrodes, difficult access to the hand, neuromuscular disease.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Statistician randomised allocation of intervention, performing central randomisation by computer. Allocation involved contacting the holder of the allocation schedule who was "off-site" and would send these to the primary research collecter.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/12/2018
Actual
Date of last participant enrolment
Anticipated
18/01/2019
Actual
Date of last data collection
Anticipated
21/01/2019
Actual
Sample size
Target
35
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 12619 0
Sydney Adventist Hospital - Wahroonga
Recruitment postcode(s) [1] 25037 0
2076 - Wahroonga

Funding & Sponsors
Funding source category [1] 301227 0
Hospital
Name [1] 301227 0
The Sydney Adventist Hospital
Country [1] 301227 0
Australia
Primary sponsor type
Hospital
Name
The Sydney Adventist Hospital
Address
185 Fox Valley Rd, Wahroonga NSW 2076
Country
Australia
Secondary sponsor category [1] 301012 0
None
Name [1] 301012 0
Address [1] 301012 0
Country [1] 301012 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301970 0
Adventist Healthcare Ltd Ethics Commitee
Ethics committee address [1] 301970 0
185 Fox Valley Rd, Wahroonga NSW 2076
Ethics committee country [1] 301970 0
Australia
Date submitted for ethics approval [1] 301970 0
28/11/2018
Approval date [1] 301970 0
07/12/2018
Ethics approval number [1] 301970 0
HREC-2018-40

Summary
Brief summary
Current recommendations by the Australian and New Zealand College of Anaesthetists professional standards are that quantitative neuromuscular transmission (NMT) monitoring be used in every case of neuromuscular blockade to ensure that the reversal of muscle relaxants is adequate. However, international surveys have demonstrated that as few as 18% of anaesthetists use quantitative neuromuscular transmission (NMT) monitoring routinely.
Common (38-64%) and potentially serious complication of general anaesthesia, including respiratory failure, airway collapse, aspiration of gastric contents. Electromyography (EMG) has emerged as the clinical gold standard for NMT monitoring. In particular, Tetragraph is a novel EMG-based monitor that has advantages over older monitors including availability as a stand-alone unit without the need for expensive and specially designed monitors. However, the differences in its electrode design and in-built method for waveform analysis can affect its relative performance to older monitors. Given its recent development, data regarding its relative precision and bias in different muscles of the hand are also lacking. Therefore the hypotheses is that the first dorsal interosseous (FDI) will be more precise and accurate in comparison to the other muscles of the hand and foot and that the Tetragraph, using the train of four ratio (TOF) stimulation of the ulnar nerve under general anaesthesia, will be more precise and accurate compared to the NMT Electrosensor, during spontaneous recovery from non-depolarizing neuromuscular blockade.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 88714 0
A/Prof Paul Stewart
Address 88714 0
SAHCS, Sydney Adventist Hospital, 185 Fox Valley Rd, Wahroonga, NSW, 2076
Country 88714 0
Australia
Phone 88714 0
+61294803660
Fax 88714 0
Email 88714 0
[email protected]
Contact person for public queries
Name 88715 0
Dr Ashley Creighton
Address 88715 0
SAHCS, Sydney Adventist Hospital, 185 Fox Valley Rd, Wahroonga, NSW, 2076
Country 88715 0
Australia
Phone 88715 0
+61294803660
Fax 88715 0
Email 88715 0
[email protected]
Contact person for scientific queries
Name 88716 0
Dr Ashley Creighton
Address 88716 0
SAHCS, Sydney Adventist Hospital, 185 Fox Valley Rd, Wahroonga, NSW, 2076
Country 88716 0
Australia
Phone 88716 0
+61294803660
Fax 88716 0
Email 88716 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Patient confidentiality and privacy.


What supporting documents are/will be available?

No Supporting Document Provided



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.