Neuromuscular BlockadeNCT03117387

Evaluation of the Tof Cuff for Perioperative Neuromuscular Transmission

An observational study of Neuromuscular Blockade, run by Leiden University Medical Center at 2 sites in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Neuromuscular Blockade
What is being tested?: Measurements of the level of neuromuscular blockade
How many people: 250 participants
Where: 2 sitesNetherlands
Study dates: 1 May 2017to 1 Jul 2020
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: American society of Anesthesiologist Physical Status class I-III patients >18 years of age BMI either < 30 or > 30 kg/m2

Who may be able to join

American society of Anesthesiologist Physical Status class I-III
>18 years of age
Ability to give oral and written informed consent

Who cannot join

Known or suspected neuromuscular disorders impairing neuromuscular function;
Allergies to muscle relaxants, anesthetics or narcotics;
A (family) history of malignant hyperthermia;
Women who are or may be pregnant or are currently breast feeding;
Renal insufficiency, as defined by a glomerular filtration rate < 30 ml/min
Scheduled for anesthesia without the use of muscle relaxants.

Trial locations and contacts

2 sites in 1 country.

Netherlands2 sites

Leiden University Medical Center
Leiden, South Holland
Medisch Centrum Haaglanden / Nederlandse Obesitas Kliniek
The Hague, South Holland

Other trials in Netherlands

About this study

Official title: Evaluation of the Tof Cuff for Perioperative Neuromuscular Transmission Monitoring During Recovery of Moderate and Deep Neuromuscular Block Compared to Acceleromyography and Electromyography

Acceleromyography (AMG) is the most wide spread used method to assess neuromuscular block during anesthesia. However AMG is known to be inaccurate when compared to the gold standard in neuromuscular transmission monitoring, electromyography (EMG). Furthermore when the patients arms require to be positioned next to the body and beneath surgical drapes, AMG measurements are often hindered and inaccurate. The TOF cuff is a new device which measures neuromuscular blockade at the upper arm with a blood pressure cuff. It overcomes the previously mentioned disadvantages of AMG. However, it validity compared to EMG and AMG has not yet fully been investigated.

This study aims to compare the bias, limits of agreement and precision of the Train-of-Four cuff relative to AMG and EMG during recovery of moderate and deep neuromuscular block in patients with normal body mass index and morbidly obese patients.

Conditions: Neuromuscular Blockade
Being tested: Measurements of the level of neuromuscular blockade

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Measurements of the level of neuromuscular blockadeDiagnostic test
Study participant were not prospectively exposed to an intervention. Administration of a moderate or deep neuromuscular blockade is at the discretion of the attending anesthesiologist. Study participants only received diagnostic non-invasive monitoring. In routine clinical care the neuromuscular blockade is monitored non-invasively by either acceleromyography, electromyography or by the TOF-Cuff. In this study participants were monitored by the monitors and were not exposed to any additional risk and no effect of an intervention was assessed in this study.

Study groups in NCT03117387
Study group	Role	What they receive
moderate neuromuscular block, normal body mass index		Patients with normal BMI (< 30) who will receive a moderate neuromuscular block (train of four 1-3 twitches) Receives: Diagnostic Test: Measurements of the level of neuromuscular blockade
deep neuromuscular block, normal body mass index		Patients with normal BMI (< 30) who will receive a deep neuromuscular block (post tetanic count of 1-2 twitches) Receives: Diagnostic Test: Measurements of the level of neuromuscular blockade
moderate neuromuscular block, high body mass index		Patients with high BMI (> 30) who will receive a moderate neuromuscular block (train of four 1-3 twitches) Receives: Diagnostic Test: Measurements of the level of neuromuscular blockade
deep neuromuscular block, high body mass index		Patients with high BMI (> 30) who will receive a deep neuromuscular block (post tetanic count of 1-2 twitches) Receives: Diagnostic Test: Measurements of the level of neuromuscular blockade

What is being measured

The primary outcome is the main question the study is designed to answer.

Depth of Neuromuscular Block During Moderate Neuromuscular Blockade (Outcome Measure/Row Title Train of Four Ratio) and During Deep Neuromuscular Blockade (Outcome Measure/ Row Title Post Tetanic Count)
Depth of as neuromuscular block will be compared between the Tof-Cuff and electromography at five minute intervals during moderate neuromuscular blockade. Bland-Altman analysis modified for repeated measurements (http://sec.lumc.nl/method_agreement_analysis). This Bland-Altman analysis corrects for between subject variability of repeated paired measurements in individual subjects. Bland-Altman analysis estimates bias and limits of agreement (95% differences between compared devices) between Tof-Cuff and electromography and evaluates instrumental imprecision by calculating the repeatability coefficient, which is equal to the standard deviation of the within-subject variability of each device. For interpretation of the Bland-Altman bias during offset of neuromuscular blockade one can assume that a bias above zero indicates that TOF-Cuff overestimates neuromuscular blockade recovery whilst a bias below zero indicates that Tof-Cuff underestimates neuromuscular blockade recovery.
Measured: at 5 minute intervals during the length of the entire procedure [which lasted between 20 to 372 minutes]; a mean of the differences between the TOF-Cuff and electromyography of all measurements is calculated and reported below

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 May 20171 Jul 2020

First posted17 Apr 2017
Study start1 May 2017
Primary completion18 Jan 2020
Study completion1 Jul 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Neuromuscular BlockadeStudies of the same condition, open and under way.
More trials run by Leiden University Medical CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 250 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03117387
Sponsor's protocol ID: P17.050
Status last verified: Sep 2023
First submitted: 28 Mar 2017
Last updated: 25 Mar 2024
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Comparative Effects Of Exercises Targeting Upper Trapezius In Patients With Non Specific Neck Pain
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All Neuromuscular Blockade trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of the Tof Cuff for Perioperative Neuromuscular Transmission Monitoring During Recovery of Moderate and Deep Neuromuscular Block Compared to Acceleromyography and Electromyography
ClinicalTrials.gov ID: NCT03117387
Acronym / sponsor ID: P17.050
Conditions: Neuromuscular Blockade
Study type: Observational
Recruitment status: Completed
Enrolment: 250 participants (actual)
Lead sponsor: Leiden University Medical CenterUniversity, hospital or other
Collaborators: Merck Sharp & Dohme LLC
Study start: 1 May 2017 (actual)
Primary completion: 18 Jan 2020 (actual)
Study completion: 1 Jul 2020 (actual)
First posted: 17 Apr 2017 (actual)
Results: Posted 25 Mar 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 4

Arm	Type	Receives
moderate neuromuscular block, normal body mass index	–	Diagnostic Test: Measurements of the level of neuromuscular blockadePatients with normal BMI (< 30) who will receive a moderate neuromuscular block (train of four 1-3 twitches)
deep neuromuscular block, normal body mass index	–	Diagnostic Test: Measurements of the level of neuromuscular blockadePatients with normal BMI (< 30) who will receive a deep neuromuscular block (post tetanic count of 1-2 twitches)
moderate neuromuscular block, high body mass index	–	Diagnostic Test: Measurements of the level of neuromuscular blockadePatients with high BMI (> 30) who will receive a moderate neuromuscular block (train of four 1-3 twitches)
deep neuromuscular block, high body mass index	–	Diagnostic Test: Measurements of the level of neuromuscular blockadePatients with high BMI (> 30) who will receive a deep neuromuscular block (post tetanic count of 1-2 twitches)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: American society of Anesthesiologist Physical Status class I-III patients >18 years of age BMI either < 30 or > 30 kg/m2

Key inclusion criteria (3 listed)

American society of Anesthesiologist Physical Status class I-III
>18 years of age
Ability to give oral and written informed consent

Key exclusion criteria (6 listed)

Known or suspected neuromuscular disorders impairing neuromuscular function;
Allergies to muscle relaxants, anesthetics or narcotics;
A (family) history of malignant hyperthermia;
Women who are or may be pregnant or are currently breast feeding;
Renal insufficiency, as defined by a glomerular filtration rate < 30 ml/min

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Measurements of the level of neuromuscular blockadeStudy participant were not prospectively exposed to an intervention. Administration of a moderate or deep neuromuscular blockade is at the discretion of the attending anesthesiologist. Study participants only received diagnostic non-invasive monitoring. In routine clinical care the neuromuscular blockade is monitored non-invasively by either acceleromyography, electromyography or by the TOF-Cuff. In this study participants were monitored by the monitors and were not exposed to any additional risk and no effect of an intervention was assessed in this study.	Diagnostic test	deep neuromuscular block, high body mass index, deep neuromuscular block, normal body mass index, moderate neuromuscular block, high body mass index, moderate neuromuscular block, normal body mass index

Primary outcome

Depth of Neuromuscular Block During Moderate Neuromuscular Blockade (Outcome Measure/Row Title Train of Four Ratio) and During Deep Neuromuscular Blockade (Outcome Measure/ Row Title Post Tetanic Count)
Time frame: at 5 minute intervals during the length of the entire procedure [which lasted between 20 to 372 minutes]; a mean of the differences between the TOF-Cuff and electromyography of all measurements is calculated and reported below
Depth of as neuromuscular block will be compared between the Tof-Cuff and electromography at five minute intervals during moderate neuromuscular blockade. Bland-Altman analysis modified for repeated measurements (http://sec.lumc.nl/method_agreement_analysis). This Bland-Altman analysis corrects for between subject variability of repeated paired measurements in individual subjects. Bland-Altman analysis estimates bias and limits of agreement (95% differences between compared devices) between Tof-Cuff and electromography and evaluates instrumental imprecision by calculating the repeatability coefficient, which is equal to the standard deviation of the within-subject variability of each device. For interpretation of the Bland-Altman bias during offset of neuromuscular blockade one can assume that a bias above zero indicates that TOF-Cuff overestimates neuromuscular blockade recovery whilst a bias below zero indicates that Tof-Cuff underestimates neuromuscular blockade recovery.

Results and safety

Results posted to the registry on 25 Mar 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Moderate Neuromuscular Block, Normal Body Mass Index	126	126
Deep Neuromuscular Block, Normal Body Mass Index	74	74
Moderate Neuromuscular Block, High Body Mass Index	43	43
Deep Neuromuscular Block, High Body Mass Index	7	7

Primary outcome: Depth of Neuromuscular Block During Moderate Neuromuscular Blockade (Outcome Measure/Row Title Train of Four Ratio) and During Deep Neuromuscular Blockade (Outcome Measure/ Row Title Post Tetanic Count)

Time frame: at 5 minute intervals during the length of the entire procedure [which lasted between 20 to 372 minutes]; a mean of the differences between the TOF-Cuff and electromyography of all measurements is calculated and reported below. Number (95% Confidence Interval). Unit: bias

Measure	Moderate Neuromuscular Block, Normal Body Mass Index n = 148	Deep Neuromuscular Block, Normal Body Mass Index n = 52	Moderate Neuromuscular Block, High Body Mass Index n = 21	Deep Neuromuscular Block, High Body Mass Index n = 29
"train-of-four ratio"	0.312 (0.287 to 0.338)	–	0.384 (0.299 to 0.469)	–
"post-tetanic-count"	–	3.405 (2.294 to 4.517)	–	-0.17 (-2.872 to 2.531)

Moderate Neuromuscular Block, Normal Body Mass Index vs Moderate Neuromuscular Block, High Body Mass Index: bias: 0.0 (0.05% CI -0.05 to 0.05)

Population analysed: The outcome measurement data indicates the difference between both devices (TOF-Cuff versus electromography) of either train of four measurements or post tetanic count measurements . Bias is a unitless number and therefore the number option is chosen as measurement type. It is neither a ratio, median or mean. The bias is zero when there is no difference between measurements.

Adverse events

Time frame: One month postoperative collection of (serious) adverse event conform the definition of clinicaltrials.gov. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Moderate Neuromuscular Block, Normal Body Mass Index	7 of 148 (4.7%)	13 of 148 (8.8%)	0 of 148
Deep Neuromuscular Block, Normal Body Mass Index	3 of 52 (5.8%)	7 of 52 (13.5%)	0 of 52
Moderate Neuromuscular Block, High Body Mass Index	0 of 21 (0%)	0 of 21 (0%)	0 of 21
Deep Neuromuscular Block, High Body Mass Index	0 of 29 (0%)	0 of 29 (0%)	0 of 29

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Neuromuscular Blockade

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Albert Dahan, MD PhD principal investigator

Leiden University Medical Center

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Neuromuscular Blockade, run by Leiden University Medical Center at 2 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Depth of Neuromuscular Block During Moderate Neuromuscular Blockade (Outcome Measure/Row Title Train of Four Ratio) and During Deep Neuromuscular Blockade (Outcome Measure/ Row Title Post Tetanic Count) (time frame: at 5 minute intervals during the length of the entire procedure [which lasted between 20 to 372 minutes]; a mean of the differences between the TOF-Cuff and electromyography of all measurements is calculated and reported below). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03117387.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2024.