The Comparison of Ventilator-driven Alveolar Maneuver in Laparoscopic Surgery； Tidal Volume Controlled vs Positive End Expiratory Pressure Controlled Cycling Maneuvers； a Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- the change of Atelectasis volume
研究概览
简要总结
During laparoscopic surgery, gas infiltration and head down position cause pulmonary atelectasis. Alveolar recruitment maneuvers are beneficial in reopening collapsed alveoli and improving lung mechanics. Ventilator-driven Alveolar recruitment maneuvers may restore lung volume but it remains unknown which method is most effective. The primary aim was to compare the efficacy of two ventilator-driven ARMs method using incremental tidal volume or positive end expiratory pressure(PEEP) until plateau pressure 30 cmH20 (within driving pressure 20 cmH20).
详细描述
General anesthesia promotes the formation of atelectasis, which negatively impacts respiratory function and may be associated with subsequent pulmonary complications. Especially, during laparoscopic surgery, gas infiltration and head down position cause pulmonary atelectasis. Alveolar recruitment maneuvers are beneficial in reopening collapsed alveoli and improving lung mechanics, suggesting that performing an Alveolar recruitment maneuvers after intubation, circuit disconnection, position change, intraabdominal gas infiltration.
Conventional manual ARM is performed by sustained lung inflation using the reservoir bag on the anaesthesia machine with the adjustable pressure-limiting valve set to the desired inflation pressure. However, the manual ARM can lead to brief loss of positive pressure when switching back to the ventilator circuit, which results in re-collapse of alveoli. For this reason, investigators try to compare the methods of the ventilator-driven ARM.
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
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients who receive laparoscopic surgery in trendelenberg position
排除标准
- •Patients who are simultaneously participating in other studies
- •Patients who are scheduled to leave the intensive care unit after surgery
- •Patients with obstructive or restrictive pattern of Severe or moderate grade on Pulmonary function test
- •High risk in cardiovascular events (expected postoperative cardiovascular event > 5%)
- •Patients with emphysema confirmed by imaging test
- •patients with obesity BMI > 35 kg / m2
结局指标
主要结局
the change of Atelectasis volume
时间窗: intraoperative time point of intubation, pneumoperitoneum and trendelenberg position, end of surgery
electrical impedance tomography monitoring: end-expiratory lung impedance, atelectasis (%)
次要结局
- the change of driving pressure value(intraoperative time point of intubation, pneumoperitoneum and trendelenberg position, end of surgery)
- the change of peak pressure value(intraoperative time point of intubation, pneumoperitoneum and trendelenberg position, end of surgery)
- the change of lung compliance value(intraoperative time point of intubation, pneumoperitoneum and trendelenberg position, end of surgery)
- the change of arterial blood gas analysis(intraoperative time point of intubation, pneumoperitoneum and trendelenberg position, end of surgery)
- The difference of atelectasis(at postoperative 30 minutes)