Individualized Supramaximal Stimulation Current During Continuous Neuromonitoring in Thyroid Surgery

NCT07710365 | Completed

• 1 other identifier: KB/202/2025
• Study Type: observational
• Target: 623
• Locations: 1 country
• Sites: 1

Brief Summary

Continuous intraoperative neuromonitoring (C-IONM) is increasingly used during thyroid surgery to detect early changes in recurrent laryngeal nerve function and reduce the risk of nerve injury. Current clinical practice recommends the use of fixed supramaximal stimulation currents; however, these recommendations are based on limited experimental evidence and may not account for individual variability between patients. This retrospective observational cohort study aims to determine patient-specific supramaximal stimulation currents (SSC) during C-IONM and to evaluate whether individualized stimulation provides monitoring quality comparable to conventional fixed-current stimulation while potentially reducing unnecessary stimulation intensity. The study also investigates factors influencing electromyographic response amplitudes during surgery and assesses the safety of individualized stimulation parameters.

Conditions

Thyroid Disease

Keywords

Thyroid surgery; Thyroidectomy; Continuous intraoperative neuromonitoring; Supramaximal stimulation current; Recurrent laryngeal nerve

Outcome Measures

Primary Outcomes (2)

• Patient-specific supramaximal stimulation current

  Distribution of the individualized supramaximal stimulation current required to achieve maximal electromyographic response during continuous intraoperative neuromonitoring of the vagus nerve.

  During surgery

• Patient-specific supramaximal stimulation current (SSC)

  Distribution of the individualized supramaximal stimulation current (SSC) required to achieve maximal electromyographic response during continuous intraoperative neuromonitoring of the vagus nerve.

  During surgery (at the beginning of continuous intraoperative neuromonitoring)

Secondary Outcomes (1)

• Electromyographic response amplitude

  During surgery

Study Arms (2)

Control cohort

Patients who underwent thyroid surgery with continuous intraoperative neuromonitoring (C-IONM) using a fixed vagus nerve stimulation current of 1.5 mA throughout the procedure. These patients were operated before implementation of the individualized stimulation protocol.

Procedure: Continuous intraoperative neuromonitoring with fixed stimulation current

Individualized SSC cohort

Patients who underwent thyroid surgery with continuous intraoperative neuromonitoring (C-IONM) using an individually determined supramaximal stimulation current (SSC). SSC was established at the beginning of the procedure for each vagus nerve and subsequently used throughout continuous monitoring.

Procedure: Continuous intraoperative neuromonitoring with individualized stimulation current

Interventions

Continuous intraoperative neuromonitoring with individualized stimulation current PROCEDURE

Continuous vagus nerve stimulation during thyroid surgery using an individually determined supramaximal stimulation current established at the beginning of the procedure.

Individualized SSC cohort

Continuous intraoperative neuromonitoring with fixed stimulation current PROCEDURE

Continuous vagus nerve stimulation during thyroid surgery using a fixed supramaximal stimulation current of 1.5 mA.

Control cohort

Eligibility Criteria

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

Study Population

The study population consisted of consecutive adult patients who underwent thyroid surgery with continuous intraoperative neuromonitoring (C-IONM) at the Department of Endocrine and General Surgery, Medical University of Gdańsk, Poland, between June 2020 and July 2024. Patients were identified retrospectively from the institutional thyroid surgery database and neuromonitoring records. Clinical and operative data were collected as part of routine clinical care. Participants were included consecutively during the study period.

You may qualify if:

• Adults aged 18 years or older.
• Patients undergoing thyroid surgery with continuous intraoperative neuromonitoring (C-IONM) of the vagus nerve.
• Availability of complete intraoperative neuromonitoring recordings suitable for analysis.
• Availability of complete clinical and operative data.

You may not qualify if:

• Age younger than 18 years.
• Incomplete or technically inadequate neuromonitoring recordings.
• Loss of signal or recurrent laryngeal nerve palsy preventing reliable amplitude analysis.
• Missing or incomplete clinical data required for the study.

Sponsors & Collaborators

• Medical University of Gdansk: lead

Study Sites (1)

The University Clinical Centre in Gdansk

Gdansk, 80-135, Poland

Location

MeSH Terms

Conditions

Thyroid Diseases

Condition Hierarchy (Ancestors)

Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2026
• First Posted: July 17, 2026
• Study Start: June 18, 2020
• Primary Completion: July 25, 2024
• Study Completion: February 11, 2025
• Last Updated: July 17, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share

Locations

PL (1)