Individualized Perioperative Open-luna Ventilatory Strategy With High Versus Conventional Inspiratory Oxygen Fraction (iPROVE-O2). A Comparative, Prospective, Multicenter, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 756
- 试验地点
- 1
- 主要终点
- Surgical site infection
研究概览
简要总结
The iPROVE-O2 trial aims at comparing the efficacy of high and conventional FiO2 within a perioperative individualized ventilatory strategy to reduce the overall incidence of SSI.
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
- Double (Investigator, Outcomes Assessor)
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
- •Age not less than 18
- •Planned abdominal surgery> 2 hours.
- •Signed informed consent for participation in the study.
排除标准
- •Age less than 18 years.
- •Pregnant or breast-feeding.
- •Patients with BMI >
- •Syndrome of moderate or severe respiratory distress: PaO2/FiO2 < 200 mmHg.
- •Heart failure: NYHA IV.
- •Hemodynamic failure: CI <2.5 L/min/m2 and / or requirements before surgery ionotropic support.
- •Diagnosis or suspicion of intracranial hypertension (intracranial pressure> 15 mmHg).
- •Mechanical ventilation in the last 15 days.
- •Presence of pneumothorax. Presence of giant bullae on chest radiography or computed tomography (CT).
- •Patient with preoperatively CPAP.
- •Participation in another experimental protocol at the time of intervention selection.
研究组 & 干预措施
High FiO2
Intraoperatively ventilated patients with a tidal volume (VT) of 8 ml / kg of ideal body weight, and a FiO2 of 0.8. After intubation, all patients were conduct an alveolar recruitment maneuver (MRA) and PEEP level individualized spanned (see Calculation of optimal PEEP). Every 40 minutes will be assessed the need to adjust the level of PEEP by evaluating the dynamic compliance of the respiratory system (Crs). Faced with a decline in Crs> 10% a new MRA and optimal PEEP setting will be assessed.
Postoperatively 3h with 0.8 FiO2 and individualized CPAP
干预措施: High FiO2 (Drug)
Conventional FiO2
Intraoperatively ventilated patients with a tidal volume (VT) of 8 ml / kg of ideal body weight, and a FiO2 of 0.3. After intubation, all patients were conduct an alveolar recruitment maneuver (MRA) and PEEP level individualized spanned (see Calculation of optimal PEEP). Every 40 minutes will be assessed the need to adjust the level of PEEP by evaluating the dynamic compliance of the respiratory system (Crs). Faced with a decline in Crs> 10% a new MRA and optimal PEEP setting will be assessed.
Postoperatively 3h with 0.3 FiO2 and individualized CPAP
干预措施: Conventional FiO2 (Drug)
结局指标
主要结局
Surgical site infection
时间窗: seven postoperative days
次要结局
- Systemic complications(seven postoperative days)
- Systemic and pulmonary complications(thirty postoperative days)
- Pulmonary complications(seven postoperative days)
研究者
Carlos Ferrando
MD,PhD
Fundación para la Investigación del Hospital Clínico de Valencia