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Individualized Supramaximal Stimulation Current During Continuous Neuromonitoring in Thyroid Surgery (CIONM-SSC)

13 de julio de 2026 actualizado por: Medical University of Gdansk

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

Descripción general del estudio

Descripción detallada

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.

Tipo de estudio

De observación

Inscripción (Actual)

623

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

      • Gdansk, Polonia, 80-135
        • The University Clinical Centre in Gdansk

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Método de muestreo

Muestra no probabilística

Población de estudio

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.

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
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.
Continuous vagus nerve stimulation during thyroid surgery using a fixed supramaximal stimulation current of 1.5 mA.
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.
Continuous vagus nerve stimulation during thyroid surgery using an individually determined supramaximal stimulation current established at the beginning of the procedure.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Patient-specific supramaximal stimulation current
Periodo de tiempo: During surgery
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)
Periodo de tiempo: 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.
During surgery (at the beginning of continuous intraoperative neuromonitoring)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Electromyographic response amplitude
Periodo de tiempo: During surgery
Comparison of electromyographic response amplitudes between individualized and fixed stimulation current protocols during continuous intraoperative neuromonitoring.
During surgery

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

18 de junio de 2020

Finalización primaria (Actual)

25 de julio de 2024

Finalización del estudio (Actual)

11 de febrero de 2025

Fechas de registro del estudio

Enviado por primera vez

13 de julio de 2026

Primero enviado que cumplió con los criterios de control de calidad

13 de julio de 2026

Publicado por primera vez (Actual)

17 de julio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

17 de julio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

13 de julio de 2026

Última verificación

1 de julio de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

De-identified individual participant data underlying the reported results will be available upon reasonable request to the corresponding author, subject to approval from the hospital administration and applicable ethical and institutional regulations.

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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