Individualized Supramaximal Stimulation Current During Continuous Neuromonitoring in Thyroid Surgery (CIONM-SSC)
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
地位
条件
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
注册 (实际的)
联系人和位置
学习地点
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Gdansk、波兰、80-135
- The University Clinical Centre in Gdansk
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
取样方法
研究人群
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
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.
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Continuous vagus nerve stimulation during thyroid surgery using a fixed supramaximal stimulation current of 1.5 mA.
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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.
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Continuous vagus nerve stimulation during thyroid surgery using an individually determined supramaximal stimulation current established at the beginning of the procedure.
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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 |
|---|---|---|
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Patient-specific supramaximal stimulation current
大体时间:During surgery
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Distribution of the individualized supramaximal stimulation current required to achieve maximal electromyographic response during continuous intraoperative neuromonitoring of the vagus nerve.
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During surgery
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Patient-specific supramaximal stimulation current (SSC)
大体时间:During surgery (at the beginning of continuous intraoperative neuromonitoring)
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Distribution of the individualized supramaximal stimulation current (SSC) required to achieve maximal electromyographic response during continuous intraoperative neuromonitoring of the vagus nerve.
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During surgery (at the beginning of continuous intraoperative neuromonitoring)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Electromyographic response amplitude
大体时间:During surgery
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Comparison of electromyographic response amplitudes between individualized and fixed stimulation current protocols during continuous intraoperative neuromonitoring.
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During surgery
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- KB/202/2025
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
药物和器械信息、研究文件
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