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临床试验/NCT07255235
NCT07255235尚未招募不适用

Comparative Evaluation of C-Mac, Pentax Video Laryngoscopes, and Macintosh Laryngoscope in Endotracheal Intubation in Intensive Care Unit Wearing a Face Shield.

Minia University1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2025年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
84
试验地点
1
主要终点
Success rate of first pass of orotracheal intubation

研究概览

简要总结

Asses and compare the practility and the level of difficulty in using C-mac and pentax video-laryngoscopes or the traditional Macintoch laryngoscope in intubation in ICU patients while wearing face shield

详细描述

The endotracheal intubation will be performed with anesthesiologist working in ICU previously trained and experienced in videolaryngoscopy and will be classified according to their skill into 3 groups: Junior (1 year up to 3 year) senior, (3 year up to 8 years) and consultant (more than 8 years) experience. All the laryngoscopist groups will equally attend in performing intubation of the studied group. After the patient consent, the allocation will be opened and preparation for intubation will start. All the intubations will be performed with the presence of two laryngoscopist: one of them at least senior or consultant. After confirmation of well working standard monitoring (ECG, blood pressure, Spo2 and End-tidal CO2) and preoxygenation with 100% oxygen, induction with propofol (1-2 mg/kg) and rocuronium (0.9 mg/kg) will be achieved by an assistant.

While wearing head-fitted face shield, the anesthetist will perform intubation with suitable sized laryngoscopy blade and endotracheal tube. Successful placement of ETT will be confirmed by both auscaltation and capnography (normal appearing waveform over four or more breathing cycles). During endotracheal intubation, anesthesiologists will be permitted to make ergonomic adjustments, such as altering the bed height, position of the patient head and utilize external laryngeal manipulations, equipment adjustment and use of stylet based on their personal preferences. After three failed attempts of intubation, alternative techniques will be used and subsequently, they will not be included in the analysis. Alternative techniques such as gum elastic bougie, laryngeal mask airway (LMA), Cricothyrotomy set will be ready to any unexpected difficult airway. An intubation attempt is defined as introduction of laryngoscope and its subsequent removal with or without endotracheal tube (ETT) placement. Correct placement of ETT in first attempt by an individual laryngoscopist will be defined as first-pass successful intubation.

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
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients between age 18 - 65 year who will need elective orotracheal intubation will be included in the study after collection of data relevant to intubation

排除标准

  • • Patients with BMI >
  • Pregnant and lactating patients.
  • Burn and facial trauma patients.
  • Suspected or confirmed spine injury.
  • Presence of any predictors or history of difficult intubation.

结局指标

主要结局

Success rate of first pass of orotracheal intubation

时间窗: Untill the end of the study in average of 1 year

Passage of the orotracheal tube from the first time confirmed By capnography

次要结局

未报告次要终点

研究者

发起方
Minia University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mai Mahmoud Mohamed Ali Mosa

Principle investigator

Minia University

研究点 (1)

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