Clinical Validation of NerveTrend vs. NerveAssure Mode of Intraoperative Neuromonitoring in Prevention of Recurrent Laryngeal Nerve Injury During Thyroid Surgery: A Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The aim of this study is to compare two distinct modes of NIM Vital application in thyroid surgery: NerveTrend vs. NerveAssure mode with respect to prevalence of early postoperative RLN injury. The hypothesis explored in this study is that NerveTrend mode may be not inferior than NerveAssure mode in intraoperative identification of impending neural injury and in prognostication of postoperative glottis function in monitored bilateral thyroid surgery. Hence, NerveTrend mode may be considered a bridge between i-IONM and NerveAssure modes, and particularly in health care environments with limited financial resources it can be considered a substantial step forward representing a modern alternative to the NerveAssure technique. A prospective, randomized study with 2 arms: NeveTrend vs. NerveAssure mode (n=132 patients and 264 nerves at risk, each). The primary outcome measure is prevalence of recurrent laryngeal nerve (RLN) injury (%) on postoperative day 1 assessed by direct laryngoscopy.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• planned, first-time, bilateral thyroid surgery

Locations
Other Locations
Poland
Department of Endocrine Surgery, Jagiellonian University College of Medicine
RECRUITING
Krakow
Contact Information
Primary
Marcin Barczynski, MD, PhD
marbar@mp.pl
+48602375939
Backup
Aleksander Konturek, MD, PhD
okont@mp.pl
+48602661123
Time Frame
Start Date: 2024-03-01
Estimated Completion Date: 2025-06-30
Participants
Target number of participants: 264
Treatments
Experimental: NerveTrend
In operations with NerveTrend mode the i-IONM stimulator will be used to test vagal response at the beginning of surgery, map out and trace the RLNs during surgery by repetitive stimulations, and in case of loss of signal (LOS) it will be used to identify the type and site of neural injury (Type I vs. Type II). Final prognostication of postoperative neral function will be based on vagal stimulation at the end of each lobectomy. In addition, the EMG trending including amplitude and latency changes from initial vagal baseline will be evaluated using the NerveTrend mode at 3 - 5min intervals to assure almost real time EMG tracing and allow for modification of surgical maneuvers in case of occurrence of severe combined events (yellow zone) in order not to end up with the LOS (red zone).
Active_comparator: NerveAssure
In operations with NerveAssure mode the i-IONM stimulator will be used to test vagal response at the beginning of surgery, map out and trace the RLNs during surgery by repetitive stimulations, and in case of loss of signal (LOS) it will be used to identify the type and site of neural injury (Type I vs. Type II). Final prognostication of postoperative neral function will be based on vagal stimulation at the end of each lobectomy. In addition, the APS electrode will be placed on the Vagus nerve to allow for Automatic Periodic Stimulation of the Vagus nerve to test the RLN condition throughout the surgery and allow for modification of surgical maneuvers in case of occurrence of severe combined events (yellow zone) in order not to end up with the LOS (red zone).
Related Therapeutic Areas
Sponsors
Leads: Marcin Barczynski

This content was sourced from clinicaltrials.gov