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Evaluation of the Tof Cuff for Perioperative Neuromuscular Transmission

NCT03117387 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 250

Last updated 2024-03-25

Study results available
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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

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Albert Dahan, MD PhD · Leiden University Medical Center

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-01
Primary Completion
2020-01-18
Completion
2020-07-01

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03117387 on ClinicalTrials.gov