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NCT03742141 · ClinicalTrials.gov registry record · NA
Intraoperative Video Laryngoscopy as Adjunct for Nerve Monitoring
A NA study, sponsored by Icahn School of Medicine at Mount Sinai.
- Completed
- Registry status
- NA
- Development phase
- 125
- Enrollment target
NCT03742141: Completed NA study, sponsored by Icahn School of Medicine at Mount Sinai.
NCT03742141 is a NA study that has completed, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 125 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03742141, a NA study, has completed, sponsored by Icahn School of Medicine at Mount Sinai.
- COMPLETED
- Registry status
- NA
- Development phase
- 125 participants
- Enrollment target
Study 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.
Primary Outcome
Frequency of congruence - IOVL used in conjunction with routine intraoperative nerve monitoring to provide additional data on nerve integrity and vocal cord functions for patients undergoing neck procedures that place the recurrent and superior laryngeal nerves at risk for injury or postoperative dysfunction. Video-captured vocal cord movement as well as the Nerveana Power Index (NPI) audio signal were recorded. Loss of signal was considered any NPI value \<100, which corresponds to loss of aud
Interventions
- DRUG Glycopyrrolate
- DEVICE Intraoperative Video Laryngoscopy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 125 participants |
| Start Date | 2018-10-17 |
| Est. Completion | 2022-01-18 |
| Phase | NA |
What the finished NCT03742141 record still lists
NCT03742141 is an interventional study that assigns participants to a tested intervention. The registered 125 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 2 interventions - of which Glycopyrrolate is the first listed.
NCT03742141 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03742141 about?
NCT03742141 is a clinical study titled "Intraoperative Video Laryngoscopy as Adjunct for Nerve Monitoring". 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 se...
What is the current status of trial NCT03742141?
This trial is currently completed. It is a NA study. The enrollment target is 125 participants. The study started on 2018-10-17. Estimated completion is 2022-01-18.
What interventions are being tested in trial NCT03742141?
The interventions under investigation include: Glycopyrrolate (DRUG), Intraoperative Video Laryngoscopy (DEVICE).
Who is sponsoring clinical trial NCT03742141?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03742141's enrollment target sits among peer trials
125 753rd of 2000 higher than 1,243 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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