A.I. Supported Laryngoscopy and Endotracheal Intubation: a Manikin Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 2
- 主要终点
- Rate of first-attempt tracheal intubation success
研究概览
简要总结
LarynGuide is a newly developed AI-supported software for video laryngoscopy that supports the user through correct placement of endotracheal tube by means of audio-visual signals and warning of incorrect or potentially dangerous handling. This prospective study assesses the performance of tracheal intubation using video laryngoscopy with larynGuide AI overlay as compared to standard video larnygoscopy an simulation setting.
详细描述
Tracheal intubation is a core competence in anesthesia and emergency medicine. This complex medical procedure aims to preserve gas exchange in the lungs. Vital for that is a secured and patent airway as soon as spontaneous ventilation ceases under general anesthesia or in life-threatening conditions like (e.g, respiratory insufficiency or resuscitation). Failure in securing an airway can result in hypoxemia, leading to neurologic damage, cardiovascular complications, and death. Complex anatomic structures or abnormalities of the upper airway, as well as airway trauma, bear the risk of failed intubation and inability to ventilate the lungs, which furthermore may result in ventilation and oxygenation failure. Tracheal intubation's success highly depends on user experience and skills. Literature reports unexpected difficult intubations ranging from 5 to 10%, mostly corresponding to a Cormack/Lehane grade 3 or 4.4-7. Besides classic direct laryngoscopes and flexible optic endoscopes, video laryngoscopes with high-resolution video cameras placed at the tip of the devices facilitate tracheal intubation. Video laryngoscopy seems superior in normal and difficult intubation, as it improves the first-attempt success rate.
Complication rates and upper airway trauma after direct laryngoscopy with a Macintosh type blade in patients with normal airway have been reported up to 7%15. Video laryngoscopy reduces that relative high incidence Upper airway trauma is increased when physical force is used during laryngoscopy to improve limited view on the glottis16 or if more than two intubation attempts are needed. The newly developed larynGuide software is an artificially intelligent video laryngoscope monitoring system which provides information to the user on visible anatomy, next steps to advance the oro-tracheal intubation to completion, and to advise on un-safe or incorrect maneuvers & interventions. As soon as the device places the scope into the trachea the provider slides the tracheal tube over the scope into the proper place of the trachea as usually done during flexible scope intubation.
Aimof this study is to determine the effects larynGuide has on tracheal intubation performance compared with standard of care video laryngoscopy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Rate of first-attempt tracheal intubation success
时间窗: 2 minutes
12 single attempts per participant
次要结局
- Time to intubation(2 minutes)
- Rate of total intubation success(2 minutes)
- Global Rating Scale of Procedural Performance(2 minutes)
- Percentage of dental damage incidence(2 minutes)
