The Effect of Ventilation With Individualized Optimal Positive End Expiratory Pressure on Postoperative Atelectasis in Patients Undergoing Robot Assisted Laparoscopic Radical Prostatectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Difference in lung ultrasound score
研究概览
简要总结
During robot-assisted radical prostatectomy, pneumoperitoneum with Trendelenburg position is used. However, perioperative atelectasis and respiratory complications may occur with high incidence due to general anesthesia and carbon dioxide pneumoperitoneum. Intraoperative ventilatory strategy to address these issues include intraoperative recruitment maneuver and positive end-expiratory pressure (PEEP). Recently, individualized optimal PEEP with minimal driving pressure or maximal respiratory compliance was reported to reduce respiratory complications after general anesthesia. A recent version of general anesthesia ventilator provides a stepwise procedure of determining optimal PEEP by calculating respiratory compliance. We investigated whether the application of individualized optimal PEEP could reduce the incidence of atelectasis and respiratory complications after robot-assisted laparoscopic radical prostatectomy compared to uniform PEEP.
详细描述
During robot-assisted radical prostatectomy, pneumoperitoneum with Trendelenburg position is used. However, perioperative atelectasis and respiratory complications may occur with high incidence due to general anesthesia and carbon dioxide pneumoperitoneum. Intraoperative ventilatory strategy to address these issues include intraoperative recruitment maneuver and positive end-expiratory pressure (PEEP). Recently, individualized optimal PEEP with minimal driving pressure or maximal respiratory compliance was reported to reduce respiratory complications after general anesthesia. A recent version of general anesthesia ventilator provides a stepwise procedure of determining optimal PEEP by calculating respiratory compliance. We investigated whether the application of individualized optimal PEEP could reduce the incidence of atelectasis and respiratory complications after robot-assisted laparoscopic radical prostatectomy compared to uniform PEEP. We plan to determine the degree of immediate postoperative atelectasis by measuring the lung ultrasound score and compare the lung ultrasound score between groups.
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)
盲法说明
Anesthesia care-provider cannot be blinded. Surgeon and outcome assessor will be blinded to the group assignment.
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing robot-assisted laparoscopic radical prostatectomy
- •Patients receiving mechanical ventilation by Aisys Care Station anesthesia ventilator
- •Patients who provided written informed consent to participate in this clinical trial
排除标准
- •American Society of Anesthesiologists physical status classification class 3 or more
- •Moderate or more obstructive or restrictive pulmonary disease
- •Preoperative adult respiratory distress syndrome or previous history of adult respiratory distress syndrome
- •history of heart failure, unstable angina, increased intracranial pressure
- •history of pneumothorax or presence of bullae
研究组 & 干预措施
Optimal PEEP
Individualized optimal PEEP will be provided during the laparoscopic period of surgery. Optimal PEEP will be determined by the automated procedure of step-wised decrease in the amount of PEEP of the anesthesia ventilator Aisys Care Station (GE Healthcare, Madison, Wisconsin, USA).
干预措施: Individualized optimal positive end-expiratory pressure (Procedure)
Conventional PEEP
A same amount of PEEP of 7 centimeter hydrogen dioxide will be provided during the laparoscopic period of surgery.
干预措施: Conventional positive end-expiratory pressure (Procedure)
结局指标
主要结局
Difference in lung ultrasound score
时间窗: 10 min after surgery
Difference in postoperative lung ultrasound score and baseline lung ultrasound score
次要结局
- Composite of respiratory complication(during postoperative seven days.)
- Postoperative Lung ultrasound score(10 min after the end of anesthesia)
- Length of intensive care unit stay(during the postoperative one month)
- Incidence of acute kidney injury(during the postoperative one month)
- Baseline lung ultrasound score(10 min before the start of anesthesia induction)
- Length of hospital stay(during the postoperative one month)
- Surgical wound infection(during the postoperative one month)
- Surgical wound dehiscence(during the postoperative one month)
- Incidence of surgical re-intervention(during the postoperative one month)
研究者
Won Ho Kim, MD
Associate Professor
Seoul National University Hospital