Evaluation of the Tof Cuff for Perioperative Neuromuscular Transmission

September 14, 2023 updated by: Albert Dahan, Leiden University Medical Center

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Zuid Holland
      • The Hague, Zuid Holland, Netherlands
        • Medisch Centrum Haaglanden / Nederlandse Obesitas Kliniek
    • Zuid-Holland
      • Leiden, Zuid-Holland, Netherlands
        • Leiden University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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)
Diagnostic test: Measurements of the level of neuromuscular blockade
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.
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)
Diagnostic test: Measurements of the level of neuromuscular blockade
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.
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)
Diagnostic test: Measurements of the level of neuromuscular blockade
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.
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)
Diagnostic test: Measurements of the level of neuromuscular blockade
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Leiden University Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Merck Sharp & Dohme LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Albert Dahan, MD PhD, Leiden University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 18, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 28, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 12, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 17, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 14, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • P17.050

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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