Intraoperative Video Laryngoscopy as Adjunct for Nerve Monitoring

NCT03742141 | Completed Results FDA Device

• 1 other identifier: GCO 17-2617
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 5

Brief 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

Keywords

Thyroidectomy; Neck Procedures; Nerve Monitoring

Outcome Measures

Primary Outcomes (1)

• Frequency of Congruence of Nerve Integrity and Vocal Cord Functions

  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

Study Arms (1)

Intraoperative Video Laryngoscopy

EXPERIMENTAL

Participants undergoing neck procedures

Device: Intraoperative Video Laryngoscopy; Drug: Glycopyrrolate

Interventions

Intraoperative Video Laryngoscopy DEVICE

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

Also known as: IOVL

Intraoperative Video Laryngoscopy

Glycopyrrolate DRUG

0.004mg/kg as per routine prior to intubation

Intraoperative Video Laryngoscopy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• NeuroVision: collaborator

Study Sites (5)

Mount Sinai Queens

Long Island City, New York, 11102, United States

Location

Mount Sinai Beth Israel

New York, New York, 10003, United States

Location

Mount Sinai West

New York, New York, 10019, United States

Location

Mount Sinai St. Luke's

New York, New York, 10025, United States

Location

The Mount Sinai Hospital

New York, New York, 10029, United States

Location

MeSH Terms

Interventions

Glycopyrrolate

Intervention Hierarchy (Ancestors)

Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. David Steinmetz
• Organization: Icahn School of Medicine at Mount Sinai

dsteinmetz0@gmail.com

646-831-5950

Study Officials

• Randall Owen, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: All patients enrolled in the study will be in a single group.

Study Record Dates

• First Submitted: November 12, 2018
• First Posted: November 15, 2018
• Study Start: October 17, 2018
• Primary Completion: January 18, 2022
• Study Completion: January 18, 2022
• Last Updated: October 2, 2023
• Results First Posted: October 2, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)