跳至主要内容
临床试验/NCT05059067
NCT05059067Unknown不适用

Macintosh Blade Size During Laryngoscopy for Endotracheal Intubation. A Prospective Observational Study.

University Hospital, Clermont-Ferrand1 个研究点 分布在 1 个国家目标入组 1,500 人开始时间: 2021年6月15日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
1,500
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, in intensive care units and in emergency medicine (in- or out-of-hospital) 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. 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. 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 whatever the circumstances: operating room, intensive care unit and emergency department (in-hospital) and in the SAMU-SMUR (pre-hospiatl medical service) at Clermont-Ferrand University Hospital.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Patients must be admitted in an operative room, an intensive care unit (ICU) or an emergency department 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
  • 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

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

  • Additional second operator(During intubation)
  • Severe complications related to intubation_death(At intubation)
  • Cormack Lehane(During intubation)
  • Difficulty of intubation(During intubation)
  • Severe complications related to intubation_hypoxemia(At intubation)
  • Moderate complications related to intubation_difficult intubation(At intubation)
  • Moderate complications related to intubation_arrythmia(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_dental injuries(At intubation)
  • POGO (percentage of glottic opening)(During intubation)
  • Moderate complications related to intubation_oesophageal intubation(At intubation)
  • Moderate complications related to intubation_agitation(At intubation)
  • Moderate complications related to intubation_aspiration(At intubation)
  • 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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