Intraoperative Positive End-Expiratory Pressure Setting Guided By Esophageal Pressure Measurement in Patients Undergoing Laparoscopic Gynecologic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Difference in PaO2 between Group E and Group C
研究概览
简要总结
The creation of pneumoperitoneum during laparoscopic surgery can have significant effects on the respiratory system including decreased respiratory system compliance, decreased vital capacity and functional residual capacity and atelectasis formation. Intraoperative mechanical ventilation, especially setting of positive end-expiratory pressure (PEEP) has an important role in respiratory management during laparoscopic surgery. The aim of this study is to determine whether setting of PEEP guided by measurement of pleural pressure would improve oxygenation and respiratory system compliance during laparoscopic surgery.
详细描述
As minimally invasive procedure with numerous advantages compared with open surgery, laparoscopic surgery has been substantially performed worldwide. The creation of pneumoperitoneum during laparoscopic surgery, however, can have significant effects on the respiratory system including decreased respiratory system compliance, decreased vital capacity and functional residual capacity and atelectasis formation. These pathophysiologic changes may put patients at risk of postoperative pulmonary complications. Therefore, intraoperative mechanical ventilation, especially setting of positive end-expiratory pressure (PEEP) has an important role in respiratory management during laparoscopic surgery. Nevertheless, there is no consensus on the optimal PEEP level and the best method to set PEEP during laparoscopic surgery. In patients with acute respiratory distress syndrome, PEEP set according to pleural pressure measured by using esophageal balloon catheter significantly has beneficial effects in terms of oxygenation, compliance and possible mortality. The aim of this study is to determine whether setting of PEEP guided by measurement of pleural pressure would improve oxygenation and respiratory system compliance during laparoscopic surgery.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with age of equal or more than 18 years old undergoing laparoscopic gynecologic surgery with anticipated surgical duration of more than 2 hours
排除标准
- •Patients with ASA physical status of equal or more than 3
- •Patients with significant cardiovascular or respiratory diseases
- •Patients with significant pathological lesion in pharynx and esophagus that preclude placement of esophageal balloon catheter
- •Patients with contraindications for PEEP titration such as increased intracranial pressure or unstable hemodynamic
- •Patients with arrhythmias
- •Patients who refuse to provide written informed consent
- •Patients undergoing surgery with duration of less than 2 hours
研究组 & 干预措施
Group E
PEEP set according to esophageal pressure measured
干预措施: PEEP setting based on esophageal pressure measured (Procedure)
Group C
PEEP set at 5 cm H2O
结局指标
主要结局
Difference in PaO2 between Group E and Group C
时间窗: At 30 minutes after arrival in recovery room
次要结局
- Difference in hemodynamics between Group E and Group C(At 15 minutes and 60 minutes after initiation of pneumoperitoneum)
- Length of hospital stay(Up to 30 days after the operation)
- Proportion of thoracoabdominal transmission of intraabdominal pressure(At 15 minutes and 60 minutes after initiation of pneumoperitoneum)
- Difference in compliance of respiratory system between Group E and Group C(At 15 minutes and 60 minutes after initiation of pneumoperitoneum, and 30 minutes after arrival in recovery room)
- Difference in alveolar dead space to tidal volume ratio between Group E and Group C(At 15 minutes and 60 minutes after initiation of pneumoperitoneum, and 30 minutes after arrival in recovery room)
- Adverse respiratory events(During 72 hours postoperatively or until discharge from hospital)
研究者
Annop Piriyapatsom, MD
Lecturer, Department of Anesthesiology, Principal Investigator
Mahidol University