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NCT Number: NCT07710365

Individualized Supramaximal Stimulation Current During Continuous Neuromonitoring in Thyroid Surgery

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The University Clinical Centre in Gdansk

Gdansk, 80-135, Poland

About this study

Continuous intraoperative neuromonitoring (C-IONM) of the vagus nerve is increasingly used during thyroid surgery to facilitate early recognition of progressive recurrent laryngeal nerve (RLN) injury. Current international recommendations advocate the use of a fixed supramaximal stimulation current, typically between 1 and 2 mA. However, these recommendations are based on limited experimental and clinical evidence and do not account for potential interindividual differences in nerve excitability.

The aim of this retrospective observational cohort study was to characterize the distribution of patient-specific supramaximal stimulation current (SSC) during C-IONM and to determine whether individualized SSC selection maintains monitoring performance compared with conventional fixed-current stimulation. Secondary objectives included evaluation of factors affecting electromyographic response amplitude and assessment of the safety of individualized stimulation.

The study included consecutive adult patients undergoing thyroid surgery with C-IONM at a tertiary endocrine surgery center. Patients operated before implementation of an updated stimulation protocol constituted the control cohort and underwent monitoring using a fixed stimulation current of 1.5 mA. After protocol implementation, SSC was individually determined for each vagus nerve at the beginning of the procedure by gradually increasing stimulation current until no further increase in electromyographic response amplitude was observed. Continuous monitoring was subsequently performed using the individualized SSC.

Neuromonitoring recordings were exported from the monitoring system, anonymized, and analyzed using dedicated Python software developed for this study. The software identified individual stimulation events, excluded incomplete or technically inadequate recordings, and extracted stimulation current and electromyographic amplitude for quantitative analysis. More than one million individual stimulation responses were evaluated.

The primary objective was to determine the distribution of individualized SSC values and compare monitoring performance between individualized and fixed-current stimulation. Secondary analyses evaluated changes in response amplitude during surgery, variability between right and left vagus nerves, factors influencing amplitude, and the occurrence of monitoring-related adverse events.

Statistical analyses included descriptive statistics, non-parametric comparisons, regression analysis, and multivariable modeling to identify independent predictors of electromyographic response amplitude.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Patient-specific supramaximal stimulation current

    Time frame: During surgery

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

  2. Patient-specific supramaximal stimulation current (SSC)

    Time frame: During surgery (at the beginning of continuous intraoperative neuromonitoring)

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

Secondary outcomes

  1. Electromyographic response amplitude

    Time frame: During surgery

    Comparison of electromyographic response amplitudes between individualized and fixed stimulation current protocols during continuous intraoperative neuromonitoring.

Sponsors and collaborators

Lead sponsor

Medical University of Gdansk

Other

Registry information

Official study title

Patient-Specific Determination of Supramaximal Stimulation Current During Continuous Intraoperative Neuromonitoring of the Recurrent Laryngeal Nerve in Thyroid Surgery

Acronym: CIONM-SSC

Important dates

Study start
2020
Primary completion
2024
Study completion
2025
First posted
Jul 17, 2026
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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