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临床试验/NCT06168162
NCT06168162招募中不适用

Effect of Individualized High Positive End-expiratory Pressure on Postoperative Pulmonary Rate in Laparoscopic Bariatric Surgeries

Ain Shams University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
1
主要终点
postoperative pulmonary complication

研究概览

简要总结

Ventilation with low tidal volume and high PEEP (positive end expiratory pressure) has been shown to improve oxygenation in patients with ARDS (acute respiratory distress syndrome). In obese patients undergoing laparoscopic bariatric surgeries, the risk of postoperative pulmonary complications (PPCs) increases significantly with general anesthesia. Previous studies have shown that protective lung ventilation strategies could improve intraoperative oxygenation and lung mechanics.

In this study would compare the effect of optimum individualized high PEEP versus standard PEEP - on postoperative pulmonary complications

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients were eligible for participation if the met the following criteria
  • Age between 18 and 60 years old.
  • Body mass index > 40
  • Laparoscopic bariatric elective surgery under general anesthesia.
  • ARISCAT (Assess Respiratory Risk in Surgical Patients in Catalonia) score ≥ 45 . ARISCAT score is a clinically practical seven-factor scoring system to assess the risk of a composite PPC.

排除标准

  • Previous lung surgery
  • ASA status III or IV.
  • Moderate to severe obstructive or restrictive lung disease .
  • Persistant intraoperative hemodynamic instability .
  • Need for postoperative mechanical ventilation

结局指标

主要结局

postoperative pulmonary complication

时间窗: postoperative 10 days after surgery

pneumonia-atelactasis-bronchospasm-respiratory failure

次要结局

  • Pulmonary functions test(postoperative 1st , 3rd and 5th day)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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