NerveTrend vs. i-IONM in Prevention of Recurrent Laryngeal Nerve Events During Bilateral Thyroid Surgery.
Thyroid Diseases, Surgery, Recurrent Laryngeal Nerve Injuries
About this trial
This is an interventional prevention trial for Thyroid Diseases focused on measuring Thyroid surgery, Intraoperative neuromonitoring, Recurrent Laryngeal Nerve Injuries
Eligibility Criteria
Inclusion Criteria:
- planned, first-time, bilateral thyroid surgery.
Exclusion Criteria:
- planned unilateral thyroid surgery,
- previous thyroid surgery,
- pregnancy
- lactation
- age < 18 years
- age > 65 years
- ASA 4-5 grade (American Society of Anesthesiology)
- inability to comply with the follow-up protocol
Sites / Locations
- Department of Endocrine Surgery, Jagiellonian University College of MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
i-IONM
NerveTrend
In operations with i-IONM mode the 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 operations with NerveTrend the IONM stimulator will be used in the same manner as in the i-IONM arm, but 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).