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NCT03891381 · ClinicalTrials.gov registry record · NA
Electromyographic Monitoring and Postoperative Recovery
A NA study, sponsored by Endeavor Health.
- Terminated
- Registry status
- NA
- Development phase
- 130
- Enrollment target
NCT03891381 is a NA study that was terminated before completion, run by Endeavor Health. The registered enrollment target is 130 participants.
The verdict
NCT03891381, a NA study, was terminated before completion, sponsored by Endeavor Health.
- TERMINATED
- Registry status
- NA
- Development phase
- 130 participants
- Enrollment target
Study Summary
Residual neuromuscular blockade (weakness) is a common occurrence in the postanesthesia care unit when muscle relaxant drugs have been used in the operating room. The only method of reliably detecting residual 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 quantitative monitor produced in the United States -the TOF-Watch. The TOF-Watch 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 TetraGraph, an electromyography (EMG) device) in the clinical setting. Patients will be randomized to receive either electromyography monitoring (EMG group-using the TetraGraph) or qualitative peripheral nerve stimulator monitoring (PNS group-the standard type of neuromuscular monitoring used at NorthShore University HealthSystem). The primary endpoint of the investigation is the incidence of postoperative residual blockade (defined as a TOF ratio \< 0.9 with TOF-Watch, the current "gold standard quantitative monitor). Secondary endpoints include a variety of standard clinical recovery variables.
Interventions
- DEVICE Tetragraph quantitative monitoring
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 130 participants |
| Start Date | 2019-03-26 |
| Est. Completion | 2020-10-20 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03891381
The ClinicalTrials.gov registry entry for NCT03891381 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 130 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Endeavor Health, which has 94 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Tetragraph quantitative monitoring is the first listed.
NCT03891381 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03891381 about?
NCT03891381 is a clinical study titled "Electromyographic Monitoring and Postoperative Recovery". Residual neuromuscular blockade (weakness) is a common occurrence in the postanesthesia care unit when muscle relaxant drugs have been used in the operating room. The only method of reliably detecting residual neuromuscular blockade is through the use of quantitative neuromuscular monitors. These de...
What is the current status of trial NCT03891381?
This trial is currently terminated. It is a NA study. The enrollment target is 130 participants. The study started on 2019-03-26. Estimated completion is 2020-10-20.
What interventions are being tested in trial NCT03891381?
The interventions under investigation include: Tetragraph quantitative monitoring (DEVICE).
Who is sponsoring clinical trial NCT03891381?
This trial is sponsored by Endeavor Health, which has 94 total clinical trials registered on ClinicalTrials.gov.
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