NCT04169607已完成不适用
Effect of Intraoperative Dynamic Compliance Guided Individualized Positive End-expiratory Pressure on Postoperative Atelectasis After Laparoscopic Bariatric Surgery: a Single-center, Double-blind Randomized Controlled Trial
Xuzhou Medical University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年12月16日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Percentage of postoperative atelectasis
研究概览
简要总结
This study intends to explore the effect of dynamic compliance guided individualized positive end-expiratory pressure titration strategy on reducing the level of postoperative atelectasis in obese patient who have laparoscopic bariatric surgery.The results of the study are to assess the effects of this intervention on the incidence，duration of postoperative atelectasis and other complications including hypoxemia etc. after laparoscopic bariatric surgery.And reducing the burden of postoperative atelectasis on patients and their families, hospitals and public resources.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Bmi ≥ 35 kg/ m2
- •over 18 years old
- •elective laparoscopic bariatric surgery (gastric bypass or sleeve)
排除标准
- •Lung bullae
- •thoracic surgery history
- •quit smoking less than 1 week
- •chronic obstructive pulmonary disease requiring oxygen
- •congestive heart failure (New York Heart Association classification ≥ III)
- •planned to be transferred to intensive care unit after surgery
- •Patients participating in another interventional study
- •Refuse to sign the informed consent
结局指标
主要结局
Percentage of postoperative atelectasis
时间窗: 60-90 minutes after extubation
The amount of postoperative atelectasis, expressed as the percentage of lung tissue in CT.
次要结局
- pulse oxygen(every 5minutes During Surgery；end of each step during RM and titration strategy)
- PaO2/FiO2 ratio(1 day before surgery(baseline)，5 minutes after anesthesia induction，1 hour after pneumoperitoneum，before extubation，30 minutes after extubation)
- Postoperative Complication(1，2，7 days after surgery)
- Quality of Recovery Score - 40 (QoR-40)(1 day before surgery(baseline)，1，2，7，30 days after surgery)
- Mini-Mental score examination (MMSE)(1 day before surgery(baseline)，1，2 days after surgery)
- Mean arterial pressure(every 5minutes During Surgery；end of each step during RM and titration strategy)
- systolic blood pressure(every 5minutes During Surgery；end of each step during RM and titration strategy)
- diastolic blood pressure(every 5minutes During Surgery；end of each step during RM and titration strategy)
- dynamic compliance(every 5minutes During Surgery；end of each step during RM and titration strategy)
- airway plateau pressure(every 5minutes During Surgery；end of each step during RM and titration strategy)
- airway peak pressure(every 5minutes During Surgery；end of each step during RM and titration strategy)
- heart rate(every 5minutes During Surgery；end of each step during RM and titration strategy)
研究者
Han Yuan
Doctor-in-charge of Anesthetist
Xuzhou Medical University
研究点 (1)
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