Incidence of Postoperative Pulmonary Complications Between Mechanical Power-based Versus Conventional Lung Protective Ventilation During One-lung Ventilation: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 164
- 试验地点
- 1
- 主要终点
- Postoperative pulmonary complication
研究概览
简要总结
The goal of this clinical trial is to determine whether a mechanical power-based lung-protective ventilation strategy during one-lung ventilation reduces the incidence of postoperative pulmonary complications in adult patients undergoing lung resection surgery.
Mechanical power during pressure-regulated volume control mode is calculated using the formula below.
Mechanical power (J/min) = 0.098 x respiratory rate x tidal volume x (inspiratory airway pressure above positive end-expiratory pressure + positive end-expiratory pressure)
The main questions it aims to answer are:
- Does a mechanical power-based lung-protective ventilation strategy significantly lower the incidence of major postoperative pulmonary complications compared to conventional ventilation?
- How does this strategy impact intraoperative hemodynamic and vital profiles (e.g., blood pressure, cardiac output, vasopressor requirements, and blood oxygen saturation) during one-lung ventilation?
Participants will:
- Be randomized to receive either a mechanical power-based lung-protective ventilation strategy or a conventional lung-protective ventilation strategy exclusively during one-lung ventilation.
- Be closely monitored for the occurrence of major postoperative pulmonary complications (atelectasis, pneumonia, acute respiratory distress syndrome, and pulmonary aspiration) and adverse events for 1 month postoperatively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, 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
- •American Society of Anesthesiologists (ASA) physical status I-III
- •Elective thoracic surgery requiring lung lobectomy under one-lung ventilation
- •Age 18 years or older
- •Written informed consent obtained from the patient
排除标准
- •Prior history of thoracic surgery
- •Emergency surgery
- •Pregnancy or lactation
- •Known contraindication to one-lung ventilation
- •Inability to provide informed consent or cooperate with the study protocol
研究组 & 干预措施
Mechanical power-based lung protective ventilation group
Patients in this group will receive the mechanical power-based lung-protective ventilation strategy during one-lung ventilation.
干预措施: Mechanical power-based lung protective ventilation (Procedure)
Conventional ventilation group
Patients in this group will receive the conventional lung-protective ventilation strategy during one-lung ventilation.
干预措施: Conventional lung protective ventilation (Procedure)
结局指标
主要结局
Postoperative pulmonary complication
时间窗: From enrollment to 7 days postoperatively
Composite of respiratory diagnoses that share common pathophysiological mechanisms, including pulmonary collapse and airway contamination: 1. atelectasis detected on computed tomography or chest radiograph, 2. pneumonia using United States Centers for Disease Control criteria, 3. acute respiratory distress syndrome using the Berlin consensus definition, and 4. pulmonary aspiration (clear clinical history AND radiological evidence).
次要结局
- Clavien-Dindo classification(From enrollment to 30 days postoperatively)
研究者
Heejoon Jeong
Anesthesiologist, Professor
Samsung Medical Center