Postoperative Complication and Hospital Stay Reduction With a Individualized Perioperative Lung Protective Ventilation During One-lung Ventilation: A Prospective, Multicenter, Randomized Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,400
- 试验地点
- 8
- 主要终点
- Reduction of postoperative pulmonary complications
研究概览
简要总结
The purpose of this study is to determine whether individualized ventilatory management during one-lung ventilation in patients scheduled for thoracic surgery, combining the use of low tidal volumes, alveolar recruitment maneuvers, individually titrated positive end-expiratory pressure and individually indicated ventilatory support will decrease postoperative pulmonary complications, ICU and hospital length of stay compared to a standardized Lung Protective Ventilation (LPV).
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
- Single (Participant)
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
- •Planned thoracic 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
OLA-iHFNC
Intraoperatively ventilated patients with a tidal volume (VT) of 5-6ml / kg of ideal body weight and respiratory rate to maintain normal carbon dioxide. After intubation, in all patients will be performed an alveolar recruitment maneuver (MRA) and a PEEP titration trial (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, high flow oxygen therapy will be individually indicated by evaluating peripheral oxygen saturation.
干预措施: Alveolar recruitment maneuver (Procedure)
OLA-iHFNC
Intraoperatively ventilated patients with a tidal volume (VT) of 5-6ml / kg of ideal body weight and respiratory rate to maintain normal carbon dioxide. After intubation, in all patients will be performed an alveolar recruitment maneuver (MRA) and a PEEP titration trial (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, high flow oxygen therapy will be individually indicated by evaluating peripheral oxygen saturation.
干预措施: PEEP Titration Trial (Procedure)
STD-O2
Intraoperatively ventilated patients with a tidal volume of 5-6 ml / kg of ideal body weightand respiratory rate to maintain normal carbon dioxide, PEEP 5 cmH2O. In this group no recruitment maneuvers or optimal PEEP setting will be performed.
Postoperatively, standard oxygen therapy.
干预措施: Lung protective ventilation (Procedure)
结局指标
主要结局
Reduction of postoperative pulmonary complications
时间窗: Up to 7 postoperative days
composite of pulmonary infection, severe respiratory failure, acute respiratory distress syndrome, pneumothorax, bronchopleural fistula, atelectasis requiring bronchoscopy, empyema.
次要结局
- Reduction of composite of postoperative complications(Up to 7 and 30 postoperative days)
- Reduction of composite of postoperative pulmonary complications(Up to 30 postoperative days)
- Intensive care unit and hospital length of stay reduction(1 year)
研究者
Carlos Ferrando
Principal Investigador
Fundación para la Investigación del Hospital Clínico de Valencia