Effects of Individualized Positive End-expiratory Pressure Guided by Driving Pressure on Postoperative Atelectasis After Bariatric Surgery in Patients With Morbid Obesity: A Single-center, Prospective, Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Incidence of postoperative pulmonary atelectasis
研究概览
简要总结
Atelectasis is a common complication in patients undergoing surgery under general anesthesia, particularly in obese patients. Postoperative atelectasis could last for more than 24h and contribute to a variety of other complications, including hypoxemia and pneumonia. We plan to conduct a single-center, randomized controlled trial in patients undergoing bariatric surgery to test the hypothesis that driving pressure guided PEEP could reduce the postoperative atelectasis.
详细描述
Positive end-expiratory pressure (PEEP) is a strategy that helps to keep alveoli open during surgery and to prevent postoperative atelectasis. A fixed PEEP without considering the respiratory mechanics in individual patients, however, is not optimal. Individualized PEEP therefore has been increasingly studied, and has been shown to improve oxygenation in both nonobese and obese patients. Studies have shown that the occurrence and prognosis of PPCs are significantly associated with high driving pressure (DP), but not with VT and PEEP. Driving pressure-guided individualized PEEP is expected to be a novel perioperative lung protection strategy. Consequently, the main aim of this study is to investigate the effect of a driving pressure-guided individualized PEEP ventilation strategy on postoperative pulmonary atelectasis in morbidly obese patients undergoing bariatric 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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 60 years old;
- •Body mass index (BMI) ≥ 40 kg/m2;
- •ASA classification I to III;
- •Signing the informed consent form for this clinical study;
排除标准
- •Respiratory infection within 4 weeks; severe respiratory system diseases; history of pulmonary and/or thoracic surgery; neuromuscular dysfunction;
- •Serious cardiac, renal or haematopoietic diseases;
- •Contraindications to PEEP；
结局指标
主要结局
Incidence of postoperative pulmonary atelectasis
时间窗: After 30 minutes of extubation
The primary outcome of this study is postoperative atelectasis measured by lung ultrasound. Each hemithorax is divided into 6 regions using 3 longitudinal lines (parasternal, anterior and posterior axillary)and 2 axial lines (one above the diaphragm and the other 1 cm above the nipples). The 12 lung regions were scanned sequentially from right to left, cranial to caudal and anterior to posterior. Each region is assessed using a 2-dimen-sional view with the probe placed parallel to the ribs. It distinguishes four progressive steps of loss of aeration according to the artifacts visualized in a scan: score 0, normal aeration (A-lines or no more than two B-lines); score 1, moderate loss of aeration (three or more well-spaced B-lines); score 2, severe loss of aeration(coalescent B-lines); and score 3, complete loss of aeration(tissue-like pattern). We define atelectasis to be significant if any region had a lung consolidation score of ≥2.
次要结局
- Postoperative pulmonary ultrasound score(After 30 minutes of extubation)
研究者
Yongtao Sun
professor
Qianfoshan Hospital