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临床试验/NCT07165314
NCT07165314已完成不适用

Assessment of Provider Position for Prehospital Tracheal Intubation Using Direct Laryngoscopy: Randomized Controlled Trial

University Hospital, Geneva1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2023年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
72
试验地点
1
主要终点
First Pass Success rate

研究概览

简要总结

Endotracheal intubation may be needed in critically ill patients in the prehospital setting, where difficult conditions may be encountered. The patient may be lying on the ground, thus complicating direct laryngoscopy as the operator's visual axis cannot be properly aligned with the patient's oral-pharyngeal-tracheal axis. The posture sitting cross-legged ("Lotus" position) at the head of the patient may allow an easier alignment of the visual axes due to a lower operator's head position and more stability. We compared the impact of the "Lotus" position with free positioning of the operator for direct laryngoscopy on intubation first pass success rate among novice operators.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •All resident doctors with 1 to 6 years of post-graduate experience working in the Emergency Department (ED) at Geneva University Hospitals (Hôpitaux Universitaires de Genève (HUG)) and penultimate year of medical school students (5th year) studying at University of Geneva Faculty of Medicine (UGFM) - Performed less than 10 ETIs prior to take part in the research

排除标准

  • •More than 6 years of post-graduate experience
  • •Performed more than 10 ETIs prior to take part in the research

研究组 & 干预措施

Free positioning

Active Comparator

干预措施: Free positioning (Procedure)

Sitting cross-legged ("Lotus" position)

Experimental

干预措施: Sitting cross-legged ("Lotus" position) (Procedure)

结局指标

主要结局

First Pass Success rate

时间窗: Periprocedural

In percentage, defined as achieving successful ETI on the initial attempt. An ETI attempt was counted since the laryngoscope blade was inserted at the dental arch, regardless of whether tracheal tube placement was attempted or not. ETI was considered successful when adequate ventilation was confirmed by chest elevation. The number of intubation attempts were limited to three, with a time limit of 60 seconds allowed per attempt.

次要结局

  • Time to Intubation(Periprocedural)
  • Time to Intubation for the first intubation attempt alone(Periprocedural)
  • Number of intubations attempts(Periprocedural)
  • Cormack and Lehane (CL) score(Periprocedural)
  • Percentage Of Glottis Opening (POGO) score(Periprocedural)
  • Subjective assessments(Periprocedural)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Cédric Cibotto

Principal Investigator

University Hospital, Geneva

研究点 (1)

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