Driving Pressure During Surgeries With High Risk for Postoperative Pulmonary Complications
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Postoperative Pulmonary Complications
研究概览
简要总结
The goal of this clinical trial is to compare two different types of perioperative mechanical ventilation (MV), specifically Protective Mechanical Ventilation (PMV) and MV with the lowest possible Driving Pressure (ΔP), in relation to the appearance of postoperative pulmonary complications (PPCs) in adult patients who are operated and have higher risk of PPCs.
The main questions it aims to answer are:
- Is MV with lower ΔP better than conventional PMV in preventing PPCs in patients with higher risk for PPCs?
- Does MV with lower ΔP decrease hospital stay, Intensive Care Unit (ICU) need and mortality?
- Does MV with lower ΔP suit better than PMV to lung characteristics and needs intraoperatively?
Researchers will compare MV with the lowest possible Driving Pressure (ΔP) to Protective Mechanical Ventilation (PMV) to see if any of this is more protective than the other concerning PPCs.
All participants will receive perioperative MV.
Half of them will receive conventional Protective Mechanical Ventilation (PMV). This will include well known generally protective settings for mechanical ventilation of patients, concerning volumes, pressures, respiratory rate, inspiratory gases and ventilation maneuvers.
The rest of participants will be ventilated with the lowest possible Driving Pressure (ΔP). This will be similar to PMV in the chosen volumes, respiratory rate, inspiratory gases and ventilation maneuvers. However, the pressure inside lung at the end of expiration, eg Positive End Expiratory Pressure (PEEP), will be not be preset for every patient. Initially, the investigators will perform a maneuver that will quantify each individual's lung characteristics and mechanics. According to this, the investigators will find the exact PEEP that seems to suit each patients lungs most, and use this perioperatively, trying to provide lungs the best conditions every time.
After the completion of the operation, all the patients will be screened for PPCs, via arterial blood testing and chest X ray, and the results will be statistically analyzed trying to find if any of the forementioned strategies of mechanical ventilation surpasses the other concerning PPCs appearance. PPCs include atelectasis, respiratory failure, bronchospasm, pleural effusion, pneumonia, aspiration and pneumothorax.
Furthermore hospital stay, ICU need and mortality will be noted. Finally, measurements of perioperative lung pressures, volumes and derived variables will be noted and compared statistically as well.
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
- 是
入选标准
- •>17 years old
- •Surgery with general anesthesia & invasive mechanical ventilation
- •Preoperative ARISCAT score estimation >25
排除标准
- •<18 years old
- •Preoperative ARISCAT score estimation <26
- •Women during pregnancy or just given birth
- •Other type of anesthesia (Not general)
- •Contraindication of administration of neuromuscular blockade agents.
- •Contraindication of cease of spontaneous ventilation.
- •Mechanical ventilation without endotracheal intubation.
- •Severe heart failure / Severe cardiac arrhythmia.
- •Severe emphysematous lung disease.
- •Patient denial of participation in the trial.
研究组 & 干预措施
Lung Protective Ventilation
CONVENTIONAL LUNG PROTECTIVE VENTILATION
This group is mechanically ventilated with Invasive Mechanical Ventilation with PEEP 8 cm H20 Tidal Volume (VT) 8 ml/kg Ideal Body Weight (IBW) Respiratory Rate (RR) --> Arterial Partial CO2 Pressure (PaCO2) = 35-45 mmHg Inspired Oxygen Fracture (FiO2) 0.4 - 0.5 --> Peripheral Oxygen Saturation (SpO2) > 93% Recruitment Maneuver (as described) every hour
干预措施: Lung Protective Ventilation (Procedure)
Minimum Driving Pressure
This group is mechanically ventilated with Invasive Mechanical Ventilation with PEEP; Initially 8 cm H2. Titrated at level with Minimum Driving Pressure after first recruitment - titration maneuver followed by new recruitment maneuver VT 8 ml/kg IBW RR --> PaCO2 = 35-45 mmHg FiO2 0.4 - 0.5 --> SpO2 > 93% Recruitment Maneuver (as described) every hour
干预措施: PEEP titration for Minimum Driving Pressure (Procedure)
结局指标
主要结局
Postoperative Pulmonary Complications
时间窗: Atelectasis -> Within 1 hour in PACURespiratory failure -> Immediately postoperatively & after 30 minutes in PACU.Bronchospasm, Pleural Effusion, Pneumonia, Aspiration Pneumonitis, Pneumothorax -> from immediately postoperative until end of study
Number of the following Postoperative Pulmonary Complications 1. Postoperative Atelectasis (based on Chest X-Ray in Post-Anesthesia Care Unit - PACU) 2. Postoperative Respiratory Failure based on Arterial Blood Gases in PACU (type I and/or II) 3. Postoperative Bronchospasm 4. Postoperative Pleural Effusion 5. Postoperative Pneumonia 6. Postoperative Aspiration Pneumonitis 7. Postoperative Postoperative Pneumothorax
次要结局
- ICU stay(From day of operation until the end of patient stay inside hospital, because of return to home or due to death.)
- 28 Day mortality(From day of operation until up to 28 days.)
- Hospital Stay(From day of operation until the end of patient stay inside hospital, because of return to home or due to death.)
- ICU need.(From day of operation until the end of patient stay inside hospital, because of return to home or due to death.)
- Mechanical Power (MP)(From the moment of beginning of operation until the moment of the end of operation and mechanical ventilation)
- Volume-normalized Mechanical Power (MPcrs)(From the moment of beginning of operation until the moment of the end of operation and mechanical ventilation)
- Elastic Power (EP)(From the moment of beginning of operation until the moment of the end of operation and mechanical ventilation)
- Volume-normalized Elastic Power (EPcrs)(From the moment of beginning of operation until the moment of the end of operation and mechanical ventilation)
研究者
Antonios Kostouros
Prinsipal Investigator, Antonios Kostouros
University General Hospital of Patras