Intraoperative Video Laryngoscopy as Adjunct for Nerve Monitoring (IOVL)

September 29, 2023 updated by: Randall Owen, Icahn School of Medicine at Mount Sinai
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

125

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Long Island City, New York, United States, 11102
        • Mount Sinai Queens
      • New York, New York, United States, 10019
        • Mount Sinai West
      • New York, New York, United States, 10029
        • The Mount Sinai Hospital
      • New York, New York, United States, 10025
        • Mount Sinai St. Luke's
      • New York, New York, United States, 10003
        • Mount Sinai Beth Israel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age 18 and older with capacity to make all medical decisions
  • Medical indication for partial or total thyroidectomy, re-operative parathyroidectomy, or neck dissection

Exclusion Criteria:

  • Patients who are under the age of 18
  • Patients who are not able to make medical decisions or consent to research

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intraoperative Video Laryngoscopy
Participants undergoing neck procedures
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.
Other Names:
  • IOVL
Drug: Glycopyrrolate
0.004mg/kg as per routine prior to intubation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of Congruence of Nerve Integrity and Vocal Cord Functions
Time Frame: up to 3 months post-resection

Frequency of congruence - IOVL used in conjunction with routine intraoperative nerve monitoring to provide additional data on nerve integrity and vocal cord functions for patients undergoing neck procedures that place the recurrent and superior laryngeal nerves at risk for injury or postoperative dysfunction.

Video-captured vocal cord movement as well as the Nerveana Power Index (NPI) audio signal were recorded. Loss of signal was considered any NPI value <100, which corresponds to loss of audio signal. The NPI is specific to the Nerveana machine, and is an index of the nerve/muscle response power (or area under the curve) as a percentage of the threshold level of response. Thus, positive EMG signal (EMG+) was an NPI value >100. Positive IOVL (IOVL+) correlated with observed vocal cord movement on nerve stimulation; negative IOVL indicated no visible vocal cord movement. Discordances were considered to be contradictory IOVL and EMG (e.g., IOVL+ EMG-) findings for a particular nerve.
up to 3 months post-resection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Icahn School of Medicine at Mount Sinai

Collaborators

NeuroVision

Investigators

  • Principal Investigator: Randall Owen, MD, Icahn School of Medicine at Mount Sinai

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 17, 2018

Primary Completion (Actual)

January 18, 2022

Study Completion (Actual)

January 18, 2022

Study Registration Dates

First Submitted

November 12, 2018

First Submitted That Met QC Criteria

November 12, 2018

First Posted (Actual)

November 15, 2018

Study Record Updates

Last Update Posted (Actual)

October 2, 2023

Last Update Submitted That Met QC Criteria

September 29, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GCO 17-2617

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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