Vocal Cord Function in Neck Procedures Clinical Trial
— IOVLOfficial title:
Intraoperative Video Laryngoscopy as Adjunct for Nerve Monitoring
| Verified date | August 2023 |
| Source | Icahn School of Medicine at Mount Sinai |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 125 |
| Est. completion date | January 18, 2022 |
| Est. primary completion date | January 18, 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Mount Sinai Queens | Long Island City | New York |
| United States | Mount Sinai Beth Israel | New York | New York |
| United States | Mount Sinai St. Luke's | New York | New York |
| United States | Mount Sinai West | New York | New York |
| United States | The Mount Sinai Hospital | New York | New York |
| Lead Sponsor | Collaborator |
|---|---|
| Icahn School of Medicine at Mount Sinai | NeuroVision |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Frequency of Congruence of Nerve Integrity and Vocal Cord Functions | 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 audio signal. The NPI is specific to the Nerveana machine, and is an index of the nerve/muscle response power (or area under the curve) as a percentage of the threshold level of response. Thus, positive EMG signal (EMG+) was an NPI value >100. Positive IOVL (IOVL+) correlated with observed vocal cord movement on nerve stimulation; negative IOVL indicated no visible vocal cord movement. Discordances were considered to be contradictory IOVL and EMG (e.g., IOVL+ EMG-) findings for a particular nerve. |
up to 3 months post-resection |