CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 125 enrolled
Drug / intervention
Glycopyrrolate +1 moredrug
Likely dose
Glycopyrrolate 0.004mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03742141
NCT03742141N/ACompleted

Intraoperative Video Laryngoscopy as Adjunct for Nerve Monitoring

Icahn School of Medicine at Mount Sinai·interventional·Posted Nov 15, 2018·Updated Oct 2, 2023

In Brief

A clinical study evaluating Intraoperative Video Laryngoscopy and Glycopyrrolate for Vocal Cord Function in Neck Procedures. Completed, enrolled 125 participants across 5 sites.

Detailed Summary

The purpose of this study is to describe the impact of adding intraoperative video laryngoscopy (IOVL) to intraoperative laryngeal nerve monitoring (IOLNM) during neck procedures when IOLNM is routinely used, including thyroidectomy and re-operative parathyroidectomy. Specifically, the study team seeks to assess how frequently the use of IOVL provided confirmatory or additional information that may affect surgeon decision-making when IOLNM alone is ambiguous, or when there is equipment malfunction or failure. The IOVL is a disposable, otherwise standard fiberoptic laryngoscope (Larynxview, Neurovision Medical, Ventura CA) that is inserted alongside the endotracheal tube following intubation for surgical procedures. It allows assessment of vocal cord movement in response to nerve stimulation. Currently, the use of IOLNM is based on audio cues, and visual assessment of external laryngeal muscle movement during surgery in response to stimulation, but no direct assessment of vocal cord movement is routinely possible. This information can be ambiguous and subject to judgement of the surgeon. The addition of IOVL provides direct assessment to vocal cord movement in response to stimulus, and may be useful in light of ambiguous IOLNM data, or limited visualization of external laryngeal muscles.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsNeuroVision

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedNov 15, 2018
Enrollment StartOct 17, 2018
Primary CompletionJan 18, 2022
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 7.6 years ago

Interventions

Intraoperative Video Laryngoscopydevice

The IOVL is a disposable, otherwise standard fiberoptic laryngoscope that is inserted alongside the endotracheal tube following intubation for surgical procedures.

Glycopyrrolatedrug

0.004mg/kg as per routine prior to intubation