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

NCT04794257 | Unknown

• 1 other identifier: ERP-2020-12499
• Study Type: interventional
• Target: 264
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Thyroid surgery; Intraoperative neuromonitoring; Recurrent Laryngeal Nerve Injuries

Outcome Measures

Primary Outcomes (1)

• Prevalence of recurrent laryngeal nerve injury (%) assessed by direct laryngoscopy

  The primary outcome measure is prevalence of recurrent laryngeal nerve (RLN) injury (%) on postoperative day 1 assessed by direct laryngoscopy.

  Postoperative day 1

Secondary Outcomes (3)

• Positive predictive value (%) of introperative neuromonitoring of recurrent laryngeal nerves in prognostication of postoperative glottis function assessed by direct laryngoscopy

  Postoperative day 1

• Negative predictive value (%) of introperative neuromonitoring of recurrent laryngeal nerves in prognostication of postoperative glottis function assessed by direct laryngoscopy

  Postoperative day 1

• Prevalence of permanent recurrent laryngeal nerve injury (%) assessed by direct laryngoscopy

  At 6 months postoperatively

Study Arms (2)

i-IONM

ACTIVE COMPARATOR

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.

Device: Neuromonitoring of the recurrent laryngeal nerves

NerveTrend

EXPERIMENTAL

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).

Device: Neuromonitoring of the recurrent laryngeal nerves

Interventions

Neuromonitoring of the recurrent laryngeal nerves DEVICE

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.

NerveTrend; i-IONM

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• planned, first-time, bilateral thyroid surgery.

You may not qualify if:

• 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

Sponsors & Collaborators

• Marcin Barczynski: lead

Study Sites (1)

Department of Endocrine Surgery, Jagiellonian University College of Medicine

Krakow, 31-202, Poland

RECRUITING

Related Publications (3)

• Randolph GW, Dralle H; International Intraoperative Monitoring Study Group; Abdullah H, Barczynski M, Bellantone R, Brauckhoff M, Carnaille B, Cherenko S, Chiang FY, Dionigi G, Finck C, Hartl D, Kamani D, Lorenz K, Miccolli P, Mihai R, Miyauchi A, Orloff L, Perrier N, Poveda MD, Romanchishen A, Serpell J, Sitges-Serra A, Sloan T, Van Slycke S, Snyder S, Takami H, Volpi E, Woodson G. Electrophysiologic recurrent laryngeal nerve monitoring during thyroid and parathyroid surgery: international standards guideline statement. Laryngoscope. 2011 Jan;121 Suppl 1:S1-16. doi: 10.1002/lary.21119.

  PMID: 21181860 BACKGROUND

• Schneider R, Randolph GW, Dionigi G, Wu CW, Barczynski M, Chiang FY, Al-Quaryshi Z, Angelos P, Brauckhoff K, Cernea CR, Chaplin J, Cheetham J, Davies L, Goretzki PE, Hartl D, Kamani D, Kandil E, Kyriazidis N, Liddy W, Orloff L, Scharpf J, Serpell J, Shin JJ, Sinclair CF, Singer MC, Snyder SK, Tolley NS, Van Slycke S, Volpi E, Witterick I, Wong RJ, Woodson G, Zafereo M, Dralle H. International neural monitoring study group guideline 2018 part I: Staging bilateral thyroid surgery with monitoring loss of signal. Laryngoscope. 2018 Oct;128 Suppl 3:S1-S17. doi: 10.1002/lary.27359. Epub 2018 Oct 5.

  PMID: 30289983 BACKGROUND

• Barczynski M, Konturek A, Stopa M, Honowska A, Nowak W. Randomized controlled trial of visualization versus neuromonitoring of the external branch of the superior laryngeal nerve during thyroidectomy. World J Surg. 2012 Jun;36(6):1340-7. doi: 10.1007/s00268-012-1547-7.

  PMID: 22402975 RESULT

MeSH Terms

Conditions

Thyroid Diseases; Recurrent Laryngeal Nerve Injuries

Condition Hierarchy (Ancestors)

Endocrine System Diseases; Laryngeal Nerve Injuries; Laryngeal Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Vagus Nerve Injuries; Cranial Nerve Injuries; Cranial Nerve Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Marcin Barczynski

  Department of Endocrine Surgery, Jagiellonian University College of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marcin Barczynski, MD, PhD

CONTACT

+48602375939; marbar@mp.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Both participants and outcomes assessor will be blinded to the respective group assignment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head, Department of Endocrine Surgery, Principal Investigator, Clinical Professor

Model Details: A prospective, randomized study with 2 arms: i-IONM vs. NeveTrend mode (n=132 patients and 264 nerves at risk, each). Patients referred to the Department of Endocrine Surgery, Third Department of General Surgery, Jagiellonian University Medical College in Krakow, for first-time thyroid surgery from April 1, 2021 onwards will be registered. Eligible patients with either benign or malignant thyroid disease will be assessed for the study. The study will be approved by the Institutional Review Board (Bioethics Committee of the Jagiellonian University).

Study Record Dates

• First Submitted: March 7, 2021
• First Posted: March 12, 2021
• Study Start: April 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: March 31, 2023
• Last Updated: May 4, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)