Intraoperative Video Laryngoscopy as Adjunct for Nerve Monitoring

NCT ID: NCT03742141

Last Updated: 2023-10-02

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

125 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-17

Study Completion Date

2022-01-18

Brief Summary

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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.

Detailed Description

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Conditions

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Vocal Cord Function in Neck Procedures

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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

OTHER

Blinding Strategy

NONE

Study Groups

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Intraoperative Video Laryngoscopy

Participants undergoing neck procedures

Group Type EXPERIMENTAL

Intraoperative Video Laryngoscopy

Intervention Type DEVICE

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

Glycopyrrolate

Intervention Type DRUG

0.004mg/kg as per routine prior to intubation

Interventions

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Intraoperative Video Laryngoscopy

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

Intervention Type DEVICE

Glycopyrrolate

0.004mg/kg as per routine prior to intubation

Intervention Type DRUG

Other Intervention Names

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IOVL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NeuroVision

INDUSTRY

Sponsor Role collaborator

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role lead

Responsible Party

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Randall Owen

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Randall Owen, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

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Mount Sinai Queens

Long Island City, New York, United States

Site Status

Mount Sinai Beth Israel

New York, New York, United States

Site Status

Mount Sinai West

New York, New York, United States

Site Status

Mount Sinai St. Luke's

New York, New York, United States

Site Status

The Mount Sinai Hospital

New York, New York, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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GCO 17-2617

Identifier Type: -

Identifier Source: org_study_id

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