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Acceleromyographic Assessment of Neuromuscular Blockade: TOF-Watch-SX Versus TOFscan

NCT02433769 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2017-04-12

No results posted yet for this study

Summary

Muscle relaxants are administered to most patients undergoing general anesthesia in order to facilitate the placement of an endotracheal tube and improve operating conditions. Despite routine reversal of these agents, many patients arrive in the recovery room with evidence of residual muscle weakness. Many studies have demonstrated that residual neuromuscular blockade (weakness) is a common occurrence after surgery. The only method of reliably detecting the presence of perioperative neuromuscular blockade is through the use of quantitative neuromuscular monitors. These devices measure and quantify the degree of muscle weakness and display the results on a screen. When using train-of-four (TOF) nerve stimulation, the ratio of the fourth muscle contraction (twitch) to the first twitch will be displayed; when this ratio is 90% (or 0.9) or greater, full recovery of muscle strength is present, and the endotracheal tube can be safely removed. At the present time, there is only one commercially-available stand-alone quantitative monitor available in the United States -the TOF-Watch (an acceleromyography device). It is not used by many clinicians because it requires experience to obtain accurate results, is expensive, and is subject to interference by factors in the operating room. The aim of this investigation is to examine a new quantitative monitor, the TOFscan (a new three dimensional acceleromyography device). In order to study the accuracy of this new device, the TOFscan will be compared to the current "clinical gold standard", the TOF-Watch-SX.

Conditions

  • Neuromuscular Blockade

Interventions

DEVICE

TOFscan

Data from the TOFscan will be compared to simultaneously measured data from the TOF-Watch-SX ("gold standard")

DEVICE

TOF-Watch-SX

Data from the TOF-Watch-SX will be compared to simultaneously measured data from the TOFscan

Sponsors & Collaborators

  • Endeavor Health

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2016-12-31
Completion
2017-05-31

Countries

  • United States

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 NCT02433769 on ClinicalTrials.gov