Effect of Individualized Versus Standardized Open-Lung Ventilation on Postoperative Pulmonary Complications in Thoracic Surgery: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 352
- 试验地点
- 1
- 主要终点
- Incidence of postoperative pulmonary complications within 7 days
研究概览
简要总结
This prospective, single-center, randomized controlled trial aims to evaluate the efficacy of an intraoperative "Individualized Open Lung Ventilation" strategy compared to a standard lung-protective ventilation strategy in patients undergoing thoracic surgery.
One-lung ventilation (OLV) is essential for thoracic surgery but can cause lung injury. While standard care often uses fixed ventilation parameters, this study investigates whether personalizing Positive End-Expiratory Pressure (PEEP) to achieve the lowest driving pressure can reduce the incidence of postoperative pulmonary complications (PPCs) within 7 days after surgery.
详细描述
Background: Postoperative pulmonary complications (PPCs) are a major cause of morbidity following thoracic surgery. One-lung ventilation (OLV), while necessary for surgical exposure, induces ischemia-reperfusion injury and mechanical stress. Current standard lung-protective ventilation (LPV) strategies typically employ low tidal volumes with a fixed Positive End-Expiratory Pressure (PEEP). However, fixed parameters may not account for individual variations in lung compliance and mechanics. This study hypothesizes that an individualized open lung approach, guided by driving pressure, will optimize lung mechanics and reduce clinical complications.
Study Design: This is a prospective, randomized controlled trial conducted at Aerospace Center Hospital. Eligible patients aged 18-75 undergoing elective video-assisted thoracic surgery (VATS) with an expected OLV duration of >1 hour will be enrolled.
Intervention Groups: Participants are randomized (1:1) into two groups:
Control Group (Standard Strategy): Patients receive volume-controlled ventilation during OLV with a tidal volume of 6 mL/kg predicted body weight (PBW) and a fixed PEEP of 5 cmH2O. No routine lung recruitment maneuvers are performed.
Experimental Group (Individualized Strategy): Patients receive a tidal volume of 4-6 mL/kg PBW. Upon initiating OLV, a lung recruitment maneuver is performed (PEEP increased to 10 cmH2O). Subsequently, a decremental PEEP trial is conducted (starting at 10 cmH2O and decreasing by 1 cmH2O steps) to identify the optimal PEEP level that produces the lowest driving pressure. This optimal PEEP is maintained for the duration of OLV.
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 (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 75 years.
- •American Society of Anesthesiologists (ASA) physical status I-III.
- •Body mass index between 18 and 30 kg/m².
- •Scheduled for elective video-assisted thoracoscopic surgery (VATS).
- •Expected duration of one-lung ventilation longer than 1 hour.
- •Able to understand the study procedures and provide written informed consent.
排除标准
- •Pregnancy or breastfeeding.
- •Emergency surgery or reoperation.
- •History of severe pulmonary disease, including chronic obstructive pulmonary disease, pulmonary fibrosis, severe emphysema, pulmonary bullae, pneumothorax, or uncontrolled asthma.
- •History of heart failure or coronary artery disease.
- •Previous thoracic surgery or mechanical ventilation within 1 month before surgery.
- •Planned postoperative mechanical ventilation.
- •Bilateral thoracic surgery.
- •Participation in another interventional clinical trial.
- •Conversion to open thoracotomy during surgery.
研究组 & 干预措施
Standard Lung-Protective Ventilation Group
干预措施: Standard Lung-Protective Ventilation (Procedure)
Individualized Open Lung Ventilation Group
干预措施: Individualized Open Lung Ventilation (Procedure)
结局指标
主要结局
Incidence of postoperative pulmonary complications within 7 days
时间窗: Within 7 days after surgery
Postoperative pulmonary complications (PPCs) occurring within 7 days after surgery, defined according to pre-specified criteria, including pneumonia, atelectasis requiring therapeutic intervention, acute respiratory distress syndrome (ARDS), respiratory failure requiring noninvasive or invasive mechanical ventilation, reintubation, or mechanical ventilation lasting longer than 48 hours.
次要结局
- Incidence of secondary postoperative pulmonary complications within 30 days(Within 30 days after surgery)
- Intraoperative Driving Pressure(From the start of mechanical ventilation until 15 minutes after the restoration of two-lung ventilation.)
- Incidence of non-pulmonary postoperative complications(Within 30 days after surgery)
- Intraoperative Dynamic Compliance(From the start of mechanical ventilation until 15 minutes after the restoration of two-lung ventilation.)
- Intraoperative Peak Airway Pressure(From the start of mechanical ventilation until 15 minutes after the restoration of two-lung ventilation.)
- Arterial Oxygen Partial Pressure to Fractional Inspired Oxygen Ratio(From the start of mechanical ventilation until 15 minutes after the restoration of two-lung ventilation.)
- Hospital Length of Stay(Participants will be followed for the duration of hospital stay, an average of 7-9 days.)
- Incidence of ICU Admission(From date of surgery until date of discharge, assessed up to 30 days)
- 30-Day Mortality(30 days post-surgery)
- Incidence of Intraoperative Hypotension(From the start of anesthesia induction until the end of surgery.)
- Incidence of Pneumothorax(Within 7 days after surgery.)
- Partial Pressure of Carbon Dioxide(From the start of mechanical ventilation until 15 minutes after the restoration of two-lung ventilation.)
- Arterial pH(From the start of mechanical ventilation until 15 minutes after the restoration of two-lung ventilation.)
- Mean Arterial Pressure(From the start of mechanical ventilation until 15 minutes after the restoration of two-lung ventilation.)
- Heart Rate(From the start of mechanical ventilation until 15 minutes after the restoration of two-lung ventilation.)
研究者
Xinrui Yin
Doctor
Aerospace Center Hospital