Intraoperative Lung Protective Ventilation in Abdominal Surgery: A Randomized Controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Composite endpoint defined as incidence of major postoperative pulmonary (defined as pneumonia, need for noninvasive ventilation or need for invasive ventilation) and extrapulmonary (SIRS, sepsis and septic shock) complications
研究概览
简要总结
The purpose of this study is to compare the influence of a lung protective ventilation with conventional ventilation on postoperative complications following major abdominal surgery.
详细描述
Postoperative complications are associated with a significant and quantifiable rate of both morbidity and mortality, increased length of hospital stay and cost of care. Intra-abdominal surgery, especially upper abdominal surgery, is an important risk factor of both pulmonary and extra-pulmonary complications. Up to 15-20% of patients will develop postoperative respiratory failure which may require respiratory support.
Recent data from both experimental and clinical studies suggested that, compared with conventional ventilation using high tidal volume (TV) without positive end-expiratory pressure (PEEP), intraoperative lung protective ventilation using low tidal volume, PEEP and recruitment maneuvers (RM) could reduce postoperative complications. Conventional ventilation promotes sustained cytokine production and could therefore contribute to development of lung injury with in patients with normal lungs. Conversely, lung protective ventilation was found to reduce pulmonary and systemic inflammation.
The primary objective is to compare a lung protective ventilation with conventional ventilation (high tidal volumes without PEEP) during abdominal surgery: 1- Conventional ventilation with TV of 10-12 mL/kg predicted body weight (PBW) without PEEP; 2- Protective lung ventilation with TV of 6-8 mL/kg PBW, PEEP of 6-8 cmH2O and RM.
Our hypothesis is that lung protective ventilation could reduce postoperative pulmonary and extra-pulmonary complications compared with conventional ventilation.
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, Investigator)
入排标准
- 年龄范围
- 40 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Planned intrabdominal surgery
- •Expected duration ≥ 2 hours
- •Age ≥ 40 yr (and <90 yr)
- •Risk of postoperative pulmonary complications (Arozullah score ≥2)
排除标准
- •Noninvasive ventilation in the last 30 days
- •Recent history of pneumonia, ALI/ARDS (in the last 30 days)
- •History of pulmonary resection
- •History of neuromuscular disease
- •Patient refusal
结局指标
主要结局
Composite endpoint defined as incidence of major postoperative pulmonary (defined as pneumonia, need for noninvasive ventilation or need for invasive ventilation) and extrapulmonary (SIRS, sepsis and septic shock) complications
时间窗: during the first seven days after surgery
次要结局
- Other postoperative complications (reintervention, wound abscess, ...)(at day 15 after surgery)
- Major complications: postoperative hypoxemia, postoperative pneumonia, acute lung injury (ALI), acute respiratory distress syndrome (ARDS), pulmonary embolism(at day 15 after surgery)
- Minor complications : atelectasis, anastomotic leakage, intrabdominal abscess(at day 15 after surgery)
- Systemic level of marker of inflammation (C Reactive protein)(at day 15 after surgery)
- Postoperative complications at day 30 after surgery(at day 30 after surgery)
- Need for ICU admission(at day 30 after surgery)
- ICU length of stay(at day 30 after surgery)
- Hospital length of stay(at day 30 after surgery)
- Mortality(at day 30 after surgery)
- Plasma levels of the soluble form of the receptor for advanced glycation end-products (sRAGE), a marker of alveolar type I cell injury(before surgery, during the immediate postoperative period and on day 1, day 3 and day 7 after surgery)