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Intraoperative Video Laryngoscopy as Adjunct for Nerve Monitoring

NCT03742141 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 125

Last updated 2023-10-02

Study results available
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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.

Conditions

  • Vocal Cord Function in Neck Procedures

Interventions

DEVICE

Intraoperative Video Laryngoscopy

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

DRUG

Glycopyrrolate

0.004mg/kg as per routine prior to intubation

Sponsors & Collaborators

Principal Investigators

  • Randall Owen, MD · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-17
Primary Completion
2022-01-18
Completion
2022-01-18
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT03742141 on ClinicalTrials.gov