CTRI/2021/05/033484已完成不适用
EFFICACY OF CRICOID PRESSURE MEASURED BY A NOVEL CRICOID PRESSURE SENSOR DEVICE- A RANDOMISED CONTROLLED TRIAL
Department of Anaesthesia and Intensive Care PGIMER Chandigarh1 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2021年5月20日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Rate of occlusion of oesophageal entrance on application of cricoid force.
研究概览
简要总结
The primary purpose is to evaluate the effectiveness of cricoid pressure when applied with and withoutthe aid of cricoid pressure sensor device. Two groups will be randomly allocated and cricoid pressure will be applied by operation theatre technician and the reading on cricoid pressure monitoring will be shown or not according to the group. The efficacy will be measured in terms of oesophagus occlusion on ultrasound and videolaryngoscopy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 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-ASA physical status 1 or 2 2-Scheduled to undergo elective surgery 3-Anaesthetic plan should include general anaesthesia requiring tracheal intubation.
排除标准
- •Denial to be a part of study.
- •Diseases with abnormalities of neck, larynx, pharynx, oesophagus or thyroid.
- •Risk of aspiration of gastric contents requiring Rapid Sequence Induction and Intubation.
- •Anticipated or predicted difficult airway.
- •BMI >35 kg/m2.
结局指标
主要结局
Rate of occlusion of oesophageal entrance on application of cricoid force.
时间窗: Immediate
次要结局
- 3-Position of occluded oesophagus in relation to glottis during application of cricoid pressure on videolaryngoscopy.(Immediate)
- Cricoid force applied at various time intervals(0s, 5s, 10s, 15s, 20s, 25s, 30s, 35s, 40s, 45s, 50s, 55s, 60s)
- Intubation time in seconds(Immediate)
- Position of occluded oesophagus in relation to glottis during application of cricoid pressure on ultrasound neck.(Immediate)
- Number of attempts for tracheal tube insertion(Immediate)
研究者
研究点 (1)
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