CTRI/2020/07/026375尚未招募不适用
To assess the time taken for successful intubation using bougie vs endotracheal tube and stylet in patients with cervical immobilization undergoing cervical spine surgery.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- PGIMER
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Time to successful intubation facilitated by the bougie vs the ET with stylet using video-laryngoscope
研究概览
简要总结
There are studies which have compared the intubation success between bougie and stylet in varied group of patients including difficult airways both actual and simulated, but there is paucity of literature comparing ETI using bougie and ETI with stylet in cervical immobilized patients. We hypothesized that time to successful intubation would be less with Bougie than ET with stylet.
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Age group: 18 yrs and Above 2.ASA Status: ASA I and II 3.Patients with cervical spine immobilization with a collar or with traction 4.Undergoing cervical spine surgery 5.Using a Video laryngoscope to visualize the cords.
排除标准
- •1.ASA III or IV Patients 2.AGE <18 YRS 3.Mouth opening of less than three fingers 4.Pregnant women 5.Patients with known distortion of the upper airway or glottic structures (eg: angioedema, epiglottitis, laryngeal mass or malignancy).
结局指标
主要结局
Time to successful intubation facilitated by the bougie vs the ET with stylet using video-laryngoscope
时间窗: Baseline, at neutral position. | point of insertion of the ETI through the glottis aperture.
次要结局
- First attempt successful intubation, overall success rate of ETI, Cervical spine motion using fluoroscopy, CL grade and rate of complications in the form of desaturation, bleeding, broken teeth, trachea-bronchial perforation, pneumothorax, vocal cord injury would be assessed as secondary outcomes(Baseline, at neutral position.)
研究者
研究点 (1)
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