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临床试验/NCT04986592
NCT04986592已完成不适用

Recurrent Laryngeal Nerve Monitoring for the Assessment of the Vocal Cords in Thyroid Surgery

Hospital Universitari Vall d'Hebron Research Institute0 个研究点目标入组 106 人开始时间: 2014年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
106
主要终点
Vocal cord palsy

研究概览

简要总结

In patients undergoing total thyroidectomy, intraoperative nerve monitoring according to the International Standards Guideline Statement may detect nerves more susceptible to injury. The aim of our study was to evaluate the independent risk factors of vocal cord palsy, including those related to pre-dissection nerve monitoring values.

Methods: Prospective observational study in 95 consecutive adult patients undergoing elective total thyroidectomy in Spain. A single experienced phonologist performed a videostroboscopy (VS) exam preoperatively and one week after surgery to assess vocal cord mobility. Each surgical procedure was performed with intermittent intraoperative neuromonitoring. Latency and amplitude values were obtained for the vagal and recurrent laryngeal nerves before surgical dissection and compared with the postoperative VS exam.

详细描述

After ethics committee approval (PR AG 129/2014), a prospective observational study was carried out at Vall d'Hebron University Hospital, a tertiary hospital in Barcelona, Spain, in accordance with the Standards for Reporting of Diagnostic Accuracy (STARD), including all consecutive adult patients undergoing total thyroidectomy during a 12-month period. All patients understood the various aspects of the study and gave written informed consent. Patient characteristics recorded were age, sex, body mass index, ASA grade, and reason for surgery, among others.

Intraoperative neuromonitoring: Neural monitoring was performed once the carotid neurovascular bundle had been identified and throughout the surgical dissection process to ensure functional integrity of the nerve. We used Avalanche XT® (Dr Langer Medical GmbH, Waldkirch, Germany) equipment fitted with paired electrodes on the tracheal tube, in contact with the vocal cords (7-10 mm above the upper edge of the tube). Intermittent neuromonitoring was performed in each patient according to the international standard guidelines for electrophysiological monitoring20. The VN and RLN were stimulated following the four-step technique (V1: initial vagal stimulation, prior identification and dissection of the VN, R1: initial stimulation of the RLN, R2: post-dissection RLN stimulation, V2: post-dissection vagal stimulation). Vagal stimulation confirmed proper functioning of the entire neuronal circuit, while also avoiding false negatives through stimulation of an injured distal RLN at the lesion site. All signals were recorded on a monitor and collected for evaluation. Vagal and RLN stimulation was programmed at 3 mA and 1 mA, respectively. The event threshold was set to 70-100 uV, and increased to 200 uV, to avoid false-positive events appearing on the monitor due to spontaneous low-level respiratory waves < 100 uV. Electromyographic signals (latency and amplitude) as well as biphasic and triphasic waves were displayed on the monitoring screen. Lack of signal occurred when the monitor showed low-amplitude waves, disturbance of the isoelectric line, multiple waves of variable and scant amplitude, interference or substantial reduction in electromyography response (< 100 uV), and a high-pitched warning sound.

Vocal cords were assessed using VS (Laryngeal Strobe 9400, Pentax Medical, USA) by a single experienced phonologist blinded to the IONM results. The VS exam was performed preoperatively and repeated one week after surgery. The diagnosis of palsy (absence of motion) was made on the basis of an observation of asymmetrical laryngeal motion. Patients with postoperative VCP began voice therapy and were monitored periodically to assess their progress.

Statistics:

The main aim of the present study was to identify independent risk factors for VCP, including those related with pre-dissection IONM values. Continuous variables are expressed as the mean (standard deviation) or the median and interquartile range (i.q.r.) prior to verification of normality by the Kolmogorov-Smirnov test, and categorical variables are expressed as the absolute value (percentage).

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • To be at least 18 years old, to accept participation in the study, and to be scheduled for a total bilateral thyroidectomy.

排除标准

  • Urgent thyroidectomy, inability to perform videostroboscopy, minor patients, patient refuse to be part of the study

结局指标

主要结局

Vocal cord palsy

时间窗: The VS exam was performed one week after surgery, through study completion, an average of 1 yearThe diagnosis of palsy (absence of motion) was made on the basis of an observation of asymmetrical laryngeal motion.

Vocal cords were assessed using videostroboscopy(Laryngeal Strobe 9400, Pentax Medical, USA) by a single experienced phonologist blinded to the neuromonitoring results

Response amplitude in recurrent laryngeal nerve in uV

时间窗: Adult patients undergoing total thyroidectomy during a 12-month period

Response amplitude reflects summated EMG activity from individual muscle fibers of the thyroarytenoid. We define monitoring waveform response amplitude as the height from the vertical measurement from the apex of the positive waveform deflection to the lowest point in the opposite polarity phase of the waveform ( peak to peak). Lack of signal occurred when the monitor showed low-amplitude response waves, in electromyography response (\< 100 uV), and a high-pitched warning sound.

Response amplitude in vagal nerve in uV

时间窗: Adult patients undergoing total thyroidectomy during a 12-month period

Response amplitude reflects summated EMG activity from individual muscle fibers of the thyroarytenoid. We define monitoring waveform response amplitude as the height from the vertical measurement from the apex of the positive waveform deflection to the lowest point in the opposite polarity phase of the waveform ( peak to peak). Lack of signal occurred when the monitor showed low-amplitude response waves, in electromyography response (\< 100 uV), and a high-pitched warning sound.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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