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

2026年7月13日 更新者: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.

研究概览

详细说明

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.

研究类型

观察性的

注册 (实际的)

623

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Gdansk、波兰、80-135
        • The University Clinical Centre in Gdansk

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

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.

描述

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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
干预/治疗
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.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Patient-specific supramaximal stimulation current
大体时间: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)
大体时间: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)

次要结果测量

结果测量
措施说明
大体时间
Electromyographic response amplitude
大体时间:During surgery
Comparison of electromyographic response amplitudes between individualized and fixed stimulation current protocols during continuous intraoperative neuromonitoring.
During surgery

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2020年6月18日

初级完成 (实际的)

2024年7月25日

研究完成 (实际的)

2025年2月11日

研究注册日期

首次提交

2026年7月13日

首先提交符合 QC 标准的

2026年7月13日

首次发布 (实际的)

2026年7月17日

研究记录更新

最后更新发布 (实际的)

2026年7月17日

上次提交的符合 QC 标准的更新

2026年7月13日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

IPD 计划说明

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.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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