N/A
N=125
Intraoperative Video Laryngoscopy as Adjunct for Nerve Monitoring
Vocal Cord Function in Neck Procedures
Bottom Line
View on ClinicalTrials.gov: NCT03742141 ↗Enrolled (actual)
125
Serious AEs
1.3%
Results posted
Oct 2023
Primary outcome: Primary: Frequency of Congruence of Nerve Integrity and Vocal Cord Functions — 68; 13; 17; 10 nerves at risk
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Intraoperative Video Laryngoscopy (Device); Glycopyrrolate (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Icahn School of Medicine at Mount Sinai
- Primary completion
- Jan 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Frequency of Congruence of Nerve Integrity and Vocal Cord Functions |
68; 13; 17; 10 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03742141). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.