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临床试验/NCT06232837
NCT06232837已完成不适用

Macintosh Blade Size During Laryngoscopy for Endotracheal Intubation in Operative Rooms. A Nationwide Prospective Observational Study.

University Hospital, Clermont-Ferrand1 个研究点 分布在 1 个国家目标入组 3,058 人开始时间: 2024年1月22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
发起方
入组人数
3,058
试验地点
1
主要终点
Number of patients with successful first-pass orotracheal intubation

研究概览

简要总结

Endotracheal intubation is a frequent procedure in the operating room but optimal Macintosh blade size remains unknown to date.

详细描述

Endotracheal intubation is an extremely frequent procedure in the operating room, in intensive care units and in emergency medicine (in- or out-of-hospital). Apart from special cases of foreseen difficult programmed intubation, direct laryngoscopy remains the most frequently used technique. It requires the use of a handle (short or long), which serves as a light source on which is adapted a Macintosh curved blade, metallic or plastic, single or multiple use. The choice of blade size is based on the experience of the physician. Most often, in adult settings, size 3 or 4 blades are used. The very spartan literature on the subject and the current recommendations do not provide any information on the choice of blade size. Our team (and others) recently concluded that intubation first attempt rates in intensive care units or emergency settings were improved when using shorter Macintosh blade size No3 vs 4 (Godet et al. Intensive Care Medicine 2022 and Landefeld et al. Critical Care Explorations 2023). We therefore wish to evaluate these practices in terms of success of the first laryngoscopy, Cormack-Lehane and POGO (percentage of glottic opening visualized) scores, the need to use an alternative technique or a second operator in operative rooms. The results will be analyzed with regard as a function and experience of the person performing the laryngoscopy, as well as the setting (urgent or scheduled). These data are usually collected during the performance of an endotracheal intubation in a nationwide fashion in French operative rooms.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

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 must be admitted in a participating operative room and require mechanical ventilation through an orotracheal tube.
  • Adult (age ≥ 18 years)
  • Subjects must be covered by public health insurance
  • Written informed consent from the patient or proxy (if present) before inclusion or once possible when patient has been included in a context of emergency.

排除标准

  • Anticipated difficult intubation requiring videolaryngoscopy or other technic in first place
  • Nasotracheal intubation
  • Refusal of study participation or to pursue the study by the patient
  • Absence of coverage by the French statutory healthcare insurance system
  • Protected person

研究组 & 干预措施

Macintosh blade size 3

Patients intubated using Macintosh blade size 3

干预措施: Direct laryngoscopy using Macintosh blade (Device)

Macintosh blade size 4

Patients intubated using Macintosh blade size 4

干预措施: Direct laryngoscopy using Macintosh blade (Device)

结局指标

主要结局

Number of patients with successful first-pass orotracheal intubation

时间窗: At intubation

The proportion of patients with successful first-pass orotracheal intubation

次要结局

  • Cormack Lehane(During laryngoscopy)
  • Moderate complications related to intubation_aspiration(At intubation)
  • Severe complications related to intubation_death(At intubation)
  • Moderate complications related to intubation_difficult intubation(At intubation)
  • Moderate complications related to intubation_agitation(At intubation)
  • Moderate complications related to intubation_dental injuries(At intubation)
  • Severe complications related to intubation_hypoxemia(At intubation)
  • Severe complications related to intubation_severe collapse(At intubation)
  • Severe complications related to intubation_cardiac arrest(At intubation)
  • Moderate complications related to intubation_arrythmia(At intubation)
  • Moderate complications related to intubation_oesophageal intubation(At intubation)
  • Difficulty of intubation(During intubation)
  • Additional second operator(During intubation)
  • Percentage of Glottic Opening(During laryngoscopy)
  • Additional airway equipment(During intubation)

研究者

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

研究点 (1)

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