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NerveTrend vs. i-IONM in Prevention of Recurrent Laryngeal Nerve Events During Bilateral Thyroid Surgery.

NCT04794257 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 264

Last updated 2021-05-04

No results posted yet for this study

Summary

The aim of this study is to compare two distinct modes of NIM Vital application in thyroid surgery: i-IONM vs. NerveTrend mode with respect to prevalence of early postoperative RLN injury.

The hypothesis explored in this study is that NerveTrend mode may be more accurate than conventional i-IONM 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 c-IONM 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 c-IONM technique and providing benefits over conventional i-IONM mode.

A prospective, randomized study with 2 arms: i-IONM vs. NeveTrend 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.

Conditions

  • Thyroid Diseases
  • Surgery
  • Recurrent Laryngeal Nerve Injuries

Interventions

DEVICE

Neuromonitoring of the recurrent laryngeal nerves

The NIM Vital system (Medtronic, Jacksonville, US) operates with surface electrodes integrated with an endotracheal NIM TriVantage tube 7.0-8.0 in diameter, which is inserted by an anesthetist between the vocal folds under direct vision during intubation. The standardized technique of IONM RLNs wll be used, including initial vagal response evaluation at the beginning and final vagal response evaluation at the end of surgery (IONM = L1+V1+R1+R2+V2+L2) according to the recommendations formulated by the International Intraoperative Neural Monitoring Study Group. The nerves will be stimulated using a monopolar electrode and the interrupted stimulation technique at 1mA, 100ms impulse duration and 4Hz frequency. In case of the bifurcated RLN nerves, the assessment includes post-stimulation response of each nerve branch. Adduction of the vocal folds is detected by the endotracheal tube electromyography and abduction by finger palpation of muscle contraction in the posterior cricoarytenoid.

Sponsors & Collaborators

  • Marcin Barczynski

    lead OTHER

Principal Investigators

  • Marcin Barczynski · Department of Endocrine Surgery, Jagiellonian University College of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-01
Primary Completion
2022-12-31
Completion
2023-03-31

Countries

  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04794257 on ClinicalTrials.gov