Intraoperative Video Laryngoscopy as Adjunct for Nerve Monitoring

Completed · Not applicable

Conditions studied: Vocal Cord Function in Neck Procedures

In brief

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.

Key facts

Study ID

NCT03742141

Run by

Icahn School of Medicine at Mount Sinai

People needed

125

Starts

2018-10-17

Expected to finish

2022-01-18

Last updated by the study team

2023-10-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Mount Sinai Queens — Long Island City, New York, United States
• Mount Sinai Beth Israel — New York, New York, United States
• Mount Sinai West — New York, New York, United States
• Mount Sinai St. Luke's — New York, New York, United States
• The Mount Sinai Hospital — New York, New York, United States

Full record on ClinicalTrials.gov

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