Safety of Pre-oxygenation with 50% oxygen- A Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- % OF PATIENTS WITH DESATURATION
研究概览
简要总结
Preoxygenation is the initiation of oxygenation prior to induction of general anaesthesia and tracheal intubation. Traditional practice of preoxygenation is done with 100% oxygen at 6-10 L/min of oxygen flow for 3-5 minutes. This helps to increase the safe apnea time for intubation. This practice results in wastage of oxygen as well could cause problems of oxygen toxicity. This study aims to establish the safety of using 50% oxygen during preoxygenation in ASA I and II patients without anticipated difficult airway. The intubation will be done by anaesthesiologists with over five years of experience.
Patients fulfilling inclusion criteria will be randomised to receive either 100% or 50% oxygen during preoxygenation. The vitals (heart rate, blood pressure and saturation) and the expired oxygen concentration will be monitored at specified time intervals. The time to intubation and any oxygenation/airway related incidents will be noted. At any time point, if there is a difficulty with mask ventilation/ intubation in those receiving 50% oxygen, they will be administered 100% oxygen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 15.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients belonging to ASA PS classes I and II posted for elective non cardiac surgeries under general anaesthesia.
排除标准
- •Following patients will be excluded ASA PS classes III and IV Emergency surgeries Anticipated difficult airway Cardiac, neurological and thoracic surgeries Pregnant and obese patients Full stomach Lack of consent Preoperative saturation less than 96 percent.
结局指标
主要结局
% OF PATIENTS WITH DESATURATION
时间窗: FROM START OF PREOXYGENATION TILL INTUBATION
次要结局
- 1. TIME TAKEN FOR INTUBATION(2. HEMODYNAMIC VARIATIONS DURING INTUBATION)
研究者
Dr Jithin Mathew Abraham
Believers Church Medical College Hospital