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Intraoperative Video Laryngoscopy as Adjunct for Nerve Monitoring (IOVL)

Mount Sinai Health System logo

Mount Sinai Health System

Status

Completed

Conditions

Vocal Cord Function in Neck Procedures

Treatments

Drug: Glycopyrrolate
Device: Intraoperative Video Laryngoscopy

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT03742141
GCO 17-2617

Details and patient eligibility

About

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.

Enrollment

125 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

125 participants in 1 patient group

Intraoperative Video Laryngoscopy
Experimental group
Description:
Participants undergoing neck procedures
Treatment:
Device: Intraoperative Video Laryngoscopy
Drug: Glycopyrrolate

Trial documents
1

Trial contacts and locations

5

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Data sourced from clinicaltrials.gov

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