Comparison of Postoperative Pulmonary Complications Between Driving Pressure Guided Ventilation and Conventional Protective Ventilation in Thoracic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,300
- 试验地点
- 2
- 主要终点
- the incidence of postoperative pulmonary complications
研究概览
简要总结
Pulmonary complications are the most common complication in thoracic surgery and the leading cause of mortality.Therefore, lung protection is utmost important, and protective ventilation is strongly recommended in thoracic surgery. Protective ventilation is a prevailing ventilatory strategy in these days and is comprised of small tidal volume, limited inspiratory pressure, and application of positive end-expiratory pressure. However, several retrospective studies recently suggested that tidal volume, inspiratory pressure, and positive end-expiratory pressure are not related to patient outcomes, or only related when they influenced the driving pressure. Recently, the investigators reported the first prospective study about the driving pressure-guided ventilation in thoracic surgery. PEEP was titrated to bring the lowest driving pressure in each patient and applied throughout the one lung ventilation. The application of individualized PEEP reduced the incidence of pulmonary complications.However, that study was small size single center study with 312 patients. Thus, investigators try to perform large scale multicenter study. Through this study investigators evaluate that driving pressure-guided ventilation can reduce the incidence of postoperative pulmonary complications compared with conventional protective ventilation in thoracic surgery.
详细描述
Nowdays, the usual setting of protective ventilation during one lung ventilation is tidal volume (VT) 5 ml/kg of predicted body weight, positive end-expiratory pressure (PEEP) 5 cm H2O and plateau pressure (Pplat) less than 25 cmH2O.
However, a high incidence of postoperative pulmonary complications is still being observed even with a protective ventilatory strategy.
Driving pressure is [Pplat - PEEP] and is the pressure required for the alveolar opening. Static lung compliance (Cstat) is expressed as [VT / (Pplat - PEEP)]. Thus, driving pressure is also expressed as [VT / Cstat]. Driving pressure has an inverse relationship with Cstat and orthodromic relationship with VT according to this formula. High driving pressure indicates poor lung condition with decreased lung compliance.
Thus, investigator try to prove that driving pressure limited ventilation is superior in preventing postoperative pulmonary complications to existing protective ventilation in large scale multicenter study.
Recruit maneuver perform all group after intubation (stepwise increase of positive end expiratory pressure 5,10,15 cmH2O with tidal volume 5mL/kg).
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults older than or equal to 19 years with American Society of Anesthesiologists physical status Ⅰ-Ⅲ Patient who undergoes one-lung ventilation (more than 60 minutes) for elective thoracic surgery
排除标准
- •The American Society of Anesthesiologists (ASA) Physical Status classification greater than or equal to 4
- •Symptoms of heart failure (hypertension, urination, pulmonary edema, left ventricular outflow rate <45%) or preoperative vasopressors
- •Patient who is received oxygen therapy and ventilation care
- •large emphysema and pneumothorax
- •pregnancy and lactation
- •patients participating in similar studies
- •Joint with other operation
- •Patient who rejects being enrolled in the study
- •Patients with elevated intracranial pressure
- •Patients with peripheral neuropathy or blood circulation disorders
- •Patients with hematology disease
- •Congenital heart disease with shunt
结局指标
主要结局
the incidence of postoperative pulmonary complications
时间窗: within the first 7 days after surgery
Postoperative pulmonary complications are defined as one or more of the following: * Hypoxia: SpO2 \< 90% * Requiring oxygen therapy: Facial mask, nasal prong, continuous positive airway pressure, non-invasive positive pressure breathing or high flow nasal oxygen supply between POD 2 and 7. * Initial ventilator supports longer than 24 h * Re-intubation * Requiring mechanical ventilation * Tracheostomy * Pneumonia * Empyema * Atelectasis requiring bronchoscopy * Acute respiratory distress syndrome * Acute lung injury * Persistent emphysema or pneumothorax or air leak requiring chest tube for 5 days or more * Prolonged pleural effusion requiring chest tube for 5 days or more * Bronchopleural fistula * Contralateral pneumothorax * Pulmonary embolism embolism
次要结局
- the incidence of coronary thrombosis(within the first 7 days after surgery)
- the incidence of septic shock(within the first 7 days after surgery)
- the incidence of postoperative surgical site complications(within the first 7 days after surgery)
- Length of stay in the intensive care unit and hospital(within the first 30 days after surgery)
- mortality(within the first 30 days after surgery)
- oxygenation(15 minutes after one-lung ventilation)
- Cstat(15 minutes after one-lung ventilation)
- the incidence of rescue ventilation(during surgery)
- the incidence of postoperative renal complications(within the first 7 days after surgery)
- the incidence of postoperative cognitive complications(within the first 7 days after surgery)
- the incidence of acute myocardial infarction(within the first 7 days after surgery)
- the incidence of new arrythmia(within the first 7 days after surgery)
- the incidence of re-admission(within the first 30 days after surgery)
- CRP(within the first 1 days after surgery)
- the incidence of postoperative transfusion(within the first 3 days after surgery)
- the incidence of cerebral infarction(within the first 7 days after surgery)