Prospective, Randomized Study in Critically Ill Patients Receiving Endotracheal Intubation: Comparison Between a Conventional Approach and Video Assisted Intubation by the VivaSight™-SL Tube
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- total number of attempts to successful intubation
研究概览
简要总结
It has been shown that videolaryngoscopy may be superior to direct laryngoscopy for endotracheal intubation in intensive care. Recently, an endotracheal tube with an integrated camera at its tip has been introduced (VivaSight-SL) allowing for direct visual confirmation of the tube's passage through the vocal cords during intubation.
Patients who are requiring urgent or endotracheal intubation in intensive care are randomized to receive either a conventional intubation with direct laryngoscopy or to receive intubation with the VivaSight-SL-Tube. Primary outcome measures are first attempt success rate and number of attempts to successful intubation.
详细描述
Background
Airway management in critically ill patients is usually performed by endotracheal intubation with direct laryngoscopy. [1, 2] However, it has been shown that videolaryngoscopy may be superior to the conventional approach in intensive care, i. e. the number of attempts to successful intubation and the rate of accidental esophageal intubation are lower and the visualization of the vocal chords is improved. [3, 4]
Recently, an endotracheal tube with an integrated camera at its tip has been introduced that permits a continuous visualization of the tube's insertion into the trachea on a monitor connected to the camera (VivaSightTM-SL, ETView Ltd., Misgav, Israel) [5]. This tube has been CE and FDA certified (http://www.etview.com/products/vivasight-sl).
It is possible to observe the passage of the tube through the vocal chords during intubation and to verify the correct placement by visualization of the tracheal cartilage. This is an advantage over videolaryngoscopy, in which the camera is mounted on the laryngoscope blade. For the VivaSightTM-SL tube, a decrease for time to intubation and an increase of first attempt success has been shown over conventional intubation in a simulator trial. [6]
In this study, the VivaSightTM-SL tube is tested against the conventional approach during elective and urgent intubations in critically ill patients.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients receiving urgent or elective endotracheal intubation in the Dept. of Intensive Care Medicine.
- •Age ≥ 18 years
- •Informed consent
排除标准
- •Age < 18 years
- •No consent
研究组 & 干预措施
VivaSight intubation
Patients are intubated with the VivaSight-SL endotracheal tube
干预措施: VivaSight intubation (Device)
conventional intubation
Patients are intubated with a conventional endotracheal tube
干预措施: conventional intubation (Device)
结局指标
主要结局
total number of attempts to successful intubation
时间窗: day 1
after successful intubation
first attempt success rate
时间窗: day 1
after first attempt of intubation
次要结局
- time to successful intubation with one attempt(day 1)
- vomiting or aspiration during intubation(day 1)
- hypotension(day 1)
- average number of attempts for intubation(day 1)
- time to successful intubation(day 1)
- decrease of SpO2 < 80%(day 1)
- accidental esophageal intubation(day 1)