IOVL: Intraoperative Video Laryngoscopy as Adjunct for Nerve Monitoring

Sponsor

Icahn School of Medicine at Mount Sinai (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03742141

Collaborator

NeuroVision (Industry)

125

Enrollment

Locations

Arm

41.5

Anticipated Duration (Months)

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Vocal Cord Function in Neck Procedures	Device: Intraoperative Video Laryngoscopy Drug: Glycopyrrolate	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

125 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

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

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Intraoperative Video Laryngoscopy as Adjunct for Nerve Monitoring

Actual Study Start Date :

Oct 17, 2018

Anticipated Primary Completion Date :

Apr 1, 2022

Anticipated Study Completion Date :

Apr 1, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Frequency of congruence [during intraoperative procedure]
Frequency of congruence between IOVL and the intraoperative nerve monitoring data.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mount Sinai Queens	Long Island City	New York	United States	11102
2	Mount Sinai Beth Israel	New York	New York	United States	10003
3	Mount Sinai West	New York	New York	United States	10019
4	Mount Sinai St. Luke's	New York	New York	United States	10025
5	The Mount Sinai Hospital	New York	New York	United States	10029

Sponsors and Collaborators

Icahn School of Medicine at Mount Sinai
NeuroVision

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Randall Owen, Associate Professor, Icahn School of Medicine at Mount Sinai

ClinicalTrials.gov Identifier:

NCT03742141

Other Study ID Numbers:

GCO 17-2617

First Posted:

Nov 15, 2018

Last Update Posted:

Oct 19, 2021

Last Verified:

Oct 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Keywords provided by Randall Owen, Associate Professor, Icahn School of Medicine at Mount Sinai

Thyroidectomy

Neck Procedures

Nerve Monitoring

Additional relevant MeSH terms:

Glycopyrrolate

Study Results

No Results Posted as of Oct 19, 2021