A Randomized Comparison Between the C-MAC and Airtraq Videolaryngoscopes for First-attempt Intubation Success in Awake Patients With Anticipated Difficult Airway.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Difference in the first attempt intubation success rate (percentage)
研究概览
简要总结
Patients with anticipated difficult airway are recommended to be managed with an awake tracheal intubation. Initially fibreoptic bronchoscopy was considered the gold standard, but in the last decade videolaryngoscopes have been demonstrated to be an efficacy alternative technique. Recently, a systematic review and meta-analysis was published investigating the efficacy and safety of videolaryngoscopy compared with fibreoptic bronchoscopy for awake tracheal intubation. Eight prospective, randomized studies were included, with different videolaryngoscopes (C-MAC, GlideScope, Pentax AWS, McGraft, and Bullard). However, a direct comparison of two different videolaryngoscopes for awake tracheal intubation in patients with anticipated difficult airway has not been performed.
详细描述
This is a clinical prospective randomized-controlled trial. The aim of this study is to compare two different devices (C-MAC videolaryngoscope and Airtraq videolaryngoscope) for awake tracheal intubation in patients with difficult airways scheduled for surgery. The primary endpoint will be to compare first-attempt intubation success rate between the two videolaryngoscopes. Secondary outcomes will be to compare: difference in the overall success rate, number of intubation attempts, Cormack-Lehane grade of glottic view, incidence of complications related to intubation, difficulty experienced by the operator, patient's tolerability of the procedure.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years and older
- •Patients with anticipated difficult airway requiring awake intubation under local anaesthesia and conscious sedation for general anesthesia.
- •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
- •Pregnancy
- •age <18 years
- •refusal of the patient
- •patient's respiratory failure
结局指标
主要结局
Difference in the first attempt intubation success rate (percentage)
时间窗: during intubation
To compare the difference in the first attempt success rate (percentage) of different awake videolaryngoscope techniques for tracheal intubation.
次要结局
- Degree of patient's confort of the procedure(24 hours after intubation)
- Cormack-Lehane grade of glottic view(during intubation)
- Degree of subjective patient's tolerability of the procedure(during intubation)
- Degree of subjective difficulty experienced by the operator(during intubation)
- Difference in the incidence of complications related to intubation (percentage)(Participants will be followed from the beginning of the intervention to 30 minutes after the intervention)
- Difference in the overall success rate (percentage)(during intubation)
- Number of intubation attempts(during intubation)
研究者
Manuel Taboada Muñiz
Professor University Of Santiago de Compostela
Hospital Clinico Universitario de Santiago