Oxygenation Procedure for Obese Patients Using High Flow Oxygen Therapy Combined With Non-invasive Ventilation During Intubation in the Operating Room: a Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 124
- 试验地点
- 5
- 主要终点
- Oxygen reserve
研究概览
简要总结
Obesity is a risk factor for difficult intubation, with an incidence of up to 15.5%, and difficult mask ventilation. Obesity also reduces the functional residual capacity (FRC) of the lungs, the main reservoir of oxygen during apnoea. Complications associated with induction and intubation in the operating room are more frequent in obese patients. Preoxygenation is a cornerstone in the management of patients at risk of desaturation during induction. The study aims to compare two oxygenation strategies , in obese patients. Oxygenation using a combination of NIV (Non Invasive Ventilation) and HFNO (High Flow Nasal Oxygen) compared with NIV alone in the operating room for induction of general anaesthesia with orotracheal intubation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient requiring general anaesthesia with orotracheal intubation in the operating room
- •Obese patient (Body Mass Index , BMI ≥ 30kg/m2)
- •Patient affiliated to or benefiting from a social security scheme
- •Patient having signed the free and informed consent form.
排除标准
- •Haemodynamic instability
- •Intubation without laryngoscopy (fibroscope intubation) or nasotracheal intubation
- •Emergency surgery not allowing patient consent.
- •Patient with a contraindication to NIV or OHD
- •Protected patients: Adults under guardianship, curatorship or other legal protection; deprived of liberty by judicial or administrative decision; pregnant, breast-feeding or parturient women; hospitalised without consent.
研究组 & 干预措施
Combined oxygenation procedure
干预措施: NIV (Non Invasive Ventilation) and HFNO (High Flow Nasal Oxygen) (Procedure)
Single oxygenation procedure
干预措施: NIV (Non Invasive Ventilation) (Procedure)
结局指标
主要结局
Oxygen reserve
时间窗: 2 minutes after intubation
The lowest level of end-tidal oxygen concentration (EtO2)
次要结局
- SpO2(during preoxygenation; before intubation; during intubation; after intubation; 2 minutes after intubation)
- Rate of EtCO2(2 minutes after intubation)
- Adverse events(Perioperative/Periprocedural)
- Patient tolerance(Day 2, at study end)