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临床试验/NCT03339141
NCT03339141已完成不适用

Comparison of Intubating Conditions in 25° Head-up Position and Strict Supine

University Hospital, Clermont-Ferrand8 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2017年11月29日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,000
试验地点
8
主要终点
POGO score

研究概览

简要总结

Tracheal intubation, particularly before surgery, is traditionally done in supine position. It was shown in the general population and in obese patients in particular, that the pre-oxygenation in a 25° head-up position provided a better efficiency of the pre-oxygenation and an apnea time longer. This position would also allow for better intubation conditions in direct laryngoscopy.

The investigators intend to assess two different patient's intubation position : supine position and 25° head-up position

详细描述

Randomization assigned in random block, stratification by operator (20 patients per operator, 10 in each group).

Interim analysis every 100 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

盲法说明

No masking

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • - patients scheduled for various surgeries requiring general anesthesia with curare, with intubation of the trachea, eligible for intubation by direct laryngoscopy.
  • > 18 years
  • patients with social security

排除标准

  • Emergency surgery.
  • Patient who requiring rapid sequence induction.
  • Intubation without curare.
  • Expected difficult intubation with planned modification of the intubation protocol (i. e. intubation under fibroscopy, airtrach or videolaryngoscopy)
  • Patient with a history of epilepsy, pulmonary or cardiovascular disease (including ischemic heart disease, symptomatic asthma or obstructive pulmonary disease).
  • Patient with mask phobia.
  • BMI> 30kg / m2
  • Patient who are refusing to take part.
  • Patient protected major, minor, pregnant women, patients deemed incapable of giving informed consent.

结局指标

主要结局

POGO score

时间窗: at day 1

valid score observed by the anesthetist performing intubation at the time of intubation. POGO score means Percentage of Glottic Opening : from 0% (none visualization of the glottic opening, worst result) to 100% (complete visualization of the glottic opening, best result), from the anterior curvature of the vocal cords to the interarytenoid node, between the posterior cartilage

次要结局

  • Episodes of desaturation and episodes of hypotension(at ady 1)
  • Mechanical complications of intubation:(at day 1)
  • Patient height(at day 1)
  • Cormack-Lehane grade(at day 1)
  • Intubation operator's comfort(at day 1)

研究者

发起方
University Hospital, Clermont-Ferrand
申办方类型
Other
责任方
Sponsor

研究点 (8)

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