Influenced the Type of Laryngoscopy the Intraoperative Nerve Monitoring During Thyroid Surgery; a Controlled, Randomized Study (LiON-Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 260
- 试验地点
- 2
- 主要终点
- Evaluation of the quality of the IONM during thyroid surgery
研究概览
简要总结
A randomized controlled prospective study of laryngoscopy and evaluation of the Intraoperative nerve monitoring during thyroid surgery comparing direct laryngoscopy and the C-MAC videolaryngoscope.
详细描述
Intraoperative nerve monitoring (IONM) is used in addition to the visual the nerve in thyroid surgery. Here, the IONM can be done by placing electrodes on an endotracheal tube. In order to guarantee a sufficient signal quality of the IONM, the electrode must be adequately positioned on the glottis. The present study pursued the question of whether the conventional direct laryngoscopy compared with video laryngoscopy allows a visually adequate tube placement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 Years No concurrent participation in another study
- •capacity to consent
- •Present written informed consent of the research participant
- •Elective surgery under general anesthesia
排除标准
- •Age <18 years
- •Existing pregnancy
- •Lack of consent
- •inability to consent
- •emergency patients
- •Emergency situations in the context of a Difficult Airway Management
- •ASA classification 4
- •situations where the possibility of accumulated gastric contents
- •Participation in another study
结局指标
主要结局
Evaluation of the quality of the IONM during thyroid surgery
时间窗: Quality IONM; intraoperative 1-3 hours
Evaluation of intraoperative loss of the EMG-Signal (Quality character of the IONM)
次要结局
- intubation success(at intubation; < 120 Seconds)
- Cormack and Lehane Classification(during the laryngoscopy; < 120 Seconds)
- Percentage of glottic opening(during the laryngoscopy; < 120 Seconds)
- IDS (intubation difficult score)(< 120 Seconds)
研究者
Marc Kriege, MD
MD
Johannes Gutenberg University Mainz