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

13 juillet 2026 mis à jour par: 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.

Aperçu de l'étude

Description détaillée

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.

Type d'étude

Observationnel

Inscription (Réel)

623

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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.

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
Intervention / Traitement
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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Patient-specific supramaximal stimulation current
Délai: 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)
Délai: 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)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Electromyographic response amplitude
Délai: During surgery
Comparison of electromyographic response amplitudes between individualized and fixed stimulation current protocols during continuous intraoperative neuromonitoring.
During surgery

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

18 juin 2020

Achèvement primaire (Réel)

25 juillet 2024

Achèvement de l'étude (Réel)

11 février 2025

Dates d'inscription aux études

Première soumission

13 juillet 2026

Première soumission répondant aux critères de contrôle qualité

13 juillet 2026

Première publication (Réel)

17 juillet 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

17 juillet 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

13 juillet 2026

Dernière vérification

1 juillet 2026

Plus d'information

Termes liés à cette étude

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime 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.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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