Comparison of Necessary Time for Successful Intubation With the Vividtrac™ and KingVision™ Videolaryngoscopes and Macintosh Blade Direct Laryngoscopy in Clinical Practice
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Intubation time
研究概览
简要总结
Comparison of various videolaryngoscope devices (Vividtrac™ and KingVision™) and direct laryngoscopy with Macintosh blade regarding laryngoscopy time, intubation time, intubation success rate, percentage of visible glottic opening (POGO score) in elective and acute clinical anaesthesiology practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Following informed consent participants are randomised into one of the device groups and general anaesthesia is induced. Primary intubation attempt is carried out with the randomised device. We do not disclose the result of randomisation with our participants prior to anaesthesia induction. Participants are already in surgical anaesthesia with muscle relaxation during the intubation attempt. As providers are the users of the intubation device masking is not possible in this regard. During outcome assessment we plan not to disclose which device was used for a certain group.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •written informed consent
- •over 18 years of age
- •elective intervention
- •no anticipated difficult airway or intubation
- •preoperative anaesthesia risk assessment by American Society of Anaesthesiologists (ASA) physical status classification: ASA grade I-II
排除标准
- 未提供
研究组 & 干预措施
Macintosh laryngoscopy
In this group intubation attempt is carried out with a standard Macintosh (size 3 or 4) direct laryngoscopy blade.
干预措施: Direct laryngoscopy (Device)
KingVision videolaryngoscope
In this group intubation attempt is carried out with KingVision videolaryngoscope with a channeled, disposable single-use blade.
干预措施: KingVision videolaryngoscope (Device)
VividTrac videolaryngoscope
In this group intubation attempt is carried out with VividTrac Adult model using a smartphone or laptop running the VividVision proprietary software.
干预措施: Vividtrac videolaryngoscope (Device)
结局指标
主要结局
Intubation time
时间窗: Measured once during the intubation attempt. Up to 120 seconds following the start of intubation attempt.
Time necessary to secure airway during the induction of general anesthesia. Intubation time is measured from the point the airway device crosses the interdental line until the completion of intubation with insufflated cuffed endotracheal tube (secured airway).
次要结局
- Percentage of glottic opening (POGO) score(Registered once during the intubation attempt. Up to 120 seconds following the start of intubation attempt.)
- Tube insertion time(Registered once during the intubation attempt. Up to 120 seconds following the start of intubation attempt.)
- Laryngoscopy time(Registered once during the intubation attempt. Up to 120 seconds following the start of intubation attempt.)
- Primary intubation attempt success rate(Measured once after intubation. Up to 120 seconds following the start of intubation attempt.)
研究者
Gábor László Woth
clinical resident, PhD
University of Pecs