Evaluation of the Tof Cuff for Perioperative Neuromuscular Transmission

NCT03117387 | Completed Results

• 1 other identifier: P17.050
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 2

Brief Summary

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

Outcome Measures

Primary Outcomes (1)

• 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.

  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

Study Arms (4)

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

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

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

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

Interventions

Measurements of the level of neuromuscular blockade DIAGNOSTIC_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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Leiden University Medical Center: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (2)

Leiden University Medical Center

Leiden, South Holland, Netherlands

Location

Medisch Centrum Haaglanden / Nederlandse Obesitas Kliniek

The Hague, South Holland, Netherlands

Location

Results Point of Contact

• Title: Maarten Honing
• Organization: LUMC

g.h.m.honing@lumc.nl

+31715264038

Study Officials

• Albert Dahan, MD PhD

  Leiden University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: March 28, 2017
• First Posted: April 17, 2017
• Study Start: May 1, 2017
• Primary Completion: January 18, 2020
• Study Completion: July 1, 2020
• Last Updated: March 25, 2024
• Results First Posted: March 25, 2024

Record last verified: 2023-09

Locations

NL (2)