Effects of Personalized PEEP Titration on Postoperative Pulmonary Outcomes in Laparoscopic Hysterectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 113
- 试验地点
- 1
- 主要终点
- Postoperative pulmonary complications (PPC)
研究概览
简要总结
The aim of this study was to investigate whether individualized PEEP application improves respiratory function and reduces the incidence of postoperative pulmonary complications (PPCs) in patients undergoing laparoscopic total hysterectomy. Investigators hypothesized that individualized PEEP would improve pulmonary oxygenation and reduce the incidence of postoperative pulmonary complications.
详细描述
The study included 113 patients who met the criteria and underwent elective laparoscopic total hysterectomy.
In the patients in the PEEPᵢ group, a recruitment maneuver was performed after intubation and after the Trendelenburg position was given. During this maneuver, the ventilator was switched to pressure-controlled mode, the I:E ratio was increased to 1:1, FiO₂ was increased to 80%, and the respiratory rate was set to 15/min. The PEEP level was increased to 20 cmH₂O with 5 cmH₂O increments every 5 respiratory cycles, and an airway opening pressure of 40 cmH₂O was obtained.
For optimal individual PEEP titration, the dynamic compliance values observed on the ventilator monitor were recorded when the PEEP reached 20 cmH₂O. The PEEP level was decreased by 2 cmH₂O every 3 respiratory cycles, and the PEEP level at which the highest compliance value was obtained was determined. The value 2 cmH₂O above this value was set as optimal PEEP, and this value was maintained throughout the surgery. The recruitment maneuver was repeated at specified time points during the surgical procedure and upon disconnection of the ventilator circuit.
Data collection was performed at several time points; before induction (T1), only hemodynamic data were recorded. Before pneumoperitoneum, 5 minutes after induction (T2) with the patient in the supine position, 20 minutes after the onset of pneumoperitoneum (T3) in the Trendelenburg position, and 60 minutes after the onset of pneumoperitoneum (T4) mechanical ventilation and hemodynamic parameters were recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •Scheduled for elective laparoscopic total hysterectomy
- •ASA physical status I-III
- •BMI ≤30 kg/m²
- •Anticipated surgical duration >2 hours
排除标准
- •Pre-existing neuromuscular disorders
- •NYHA class III/IV heart failure
- •Previous lung surgery
- •Severe pulmonary disease (FEV1 <50% predicted)
研究组 & 干预措施
individualized PEEP (PEEPi)
In the patients in the PEEPᵢ group, a recruitment maneuver was performed after intubation and after the Trendelenburg position was given. The PEEP level was increased to 20 cmH₂O with 5 cmH₂O increments every five respiratory cycles, and an airway opening pressure of 40 cmH₂O was achieved. Dynamic compliance values observed on the ventilator monitor were recorded for optimal individual PEEP titration when PEEP reached 20 cmH₂O. The PEEP level was decreased by 2 cmH₂O every 3 respiratory cycles to determine the PEEP level at which the highest compliance value was achieved. 2 cmH₂O above this value was set as optimal PEEP, and this value was maintained throughout the surgery.
干预措施: Dynamic compliance guided individualized positive end-expiratory pressure titration strategy (Procedure)
PEEP 5
Patients in the PEEP 5 group were applied a fixed 5 cmH2O PEEP, and no recruitment maneuver was performed.
干预措施: standardized 5 PEEP (Procedure)
结局指标
主要结局
Postoperative pulmonary complications (PPC)
时间窗: within 7 days after surgery
PPC included clinical conditions such as atelectasis, hypoxemia (PaO₂ \< 8.0 kPa or SpO₂ \< 90% on room air), pneumonia, acute respiratory distress syndrome (ARDS), pleural effusion, bronchospasm, pneumothorax, reintubation or need for non-invasive ventilation support.
次要结局
- Intensive care(within 7 days after surgery)
- Intraoperative respiratory mechanics parameter(within intraoperative period)
- Respiratory mechanics parameter(intraoperatively)
- Mechanic ventilation parameter(during intraoperative period)
- Intensive care(within 7 days after surgery)
研究者
Beyhan Guner
Principal Investigator
Bakirkoy Dr. Sadi Konuk Research and Training Hospital