Comparison of High Flow Nasal Oxygenation and Face Mask Oxygenation for Prolongation of Safe Apnoea Time in Obese Patients Undergoing Elective Surgery under General Anaesthesia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- 1. Number of patients in each group in whom apnoea time is less than 6 minutes.
研究概览
简要总结
This is an interventional parallel group study design to compare high flow nasal oxygenation and face mask oxygenation for prolongation of safe apnoea time in obese patients undergoing elective surgery under general anaesthesia ,since there is a paucity of studies in the Indian population for the same.The primary objective is to compare high flow nasal oxygenation and face mask oxygenation for prolongation of safe apnoea time in obese patients undergoing elective surgery. The secondary objective are to compare ventilation and assess change in hemodynamic parameters and compare patient comfort between the two techniques. Patients will be allocated in two groups ,with 31 patients in each group . Group A patients will receive preoxygenation with High Flow Nasal Oxygenation at 40L/minute for 1 minute and 70L/minute for 2 minutes ; Group B patients will recieve preoxygenation with 100% oxygen through tightly held face mask at 10L/minute with CPAP of 5 cm of H2O. The primary outcome measures are number of patients in each group in whom apnoea time is less than 6 minutes and time taken for spo2 to reach 94% .The secondary outcome measures are maximum etco2 reached after start of ventilation, arterial blood gas analysis at baseline,at the end of preoxygenation and at the end of apnoea time, hemodynamic changes and patients comfort level.The data will be collected ,analysed and statistically evaluated .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- •Body mass index (BMI) ≥30 kg/m2.
排除标准
- •Patients with risk factors for difficult airway (indication for flexible optic intubation, high risk of regurgitation or expected difficult mask ventilation).
- •Uncontrolled gastric reflux disease.
- •Inability to breathe through nose due to nasopharyngeal obstruction or compulsive mouth breather.
- •Pregnant patients.
- •Known case of any systemic disorder such as cardiac, respiratory, renal or hepatic.
结局指标
主要结局
1. Number of patients in each group in whom apnoea time is less than 6 minutes.
时间窗: Every 1 minute for 6 minutes
2. In these patients, time taken for SPO2 to reach 94% after induction of anaesthesia.
时间窗: Every 1 minute for 6 minutes
次要结局
- 1) Maximum EtCO2 reached after start of ventilation.(2) Arterial blood gas analysis will be done at the following intervals. Baseline on room air , at the end of preoxygenation which is also start of apnoea time, and at the end of apnoea time.)
研究者
Falak Faizan
ABVIMS and RML Hospital
