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临床试验/NCT07525232
NCT07525232招募中不适用

Comparison of Stepwise PEEP vs Sustained Inflation Recruitment Maneuvers on Postoperative Oxygenation and Atelectasis in Bariatric Surgery Patients

Ain Shams University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2026年3月19日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
1
主要终点
Postoperative lung aeration

研究概览

简要总结

Male and female patients Undergoing laparoscopic bariatric surgeries will be subjected for lung recruitment at end of surgery before emergence from anesthesia by two different methods . to evaluate which might be safer and more effective

详细描述

In the SI group:, the anesthesiologist adjust the ventilator to manual ventilation mode and ad¬just The ventilator will be switched to manual mode, and the airway pressure-limiting valve will be set to 30 cmH₂O. A sustained manual inflation was then applied by gradually squeezing the anesthesia reservoir bag over 3-5 seconds until a peak airway pressure (Ppeak) of 30 cmH₂O was achieved. This pressure was maintained continuously for 30 seconds. Following the maneuver, mechanical ventilation was resumed with positive end-expiratory pressure (PEEP) back to 5 cmho In the IP group:, alveolar recruitment will be performed as follows: ventilation will be set to pressure control mode and the driving pressure maintained at 10 cmH2O with an initial PEEP of 5 cmH2O, respiratory rate 8-10, I:E 1-1PEEP will be then increased by 5 cmH2O ev¬ery 30 s until the Ppeak reached 30 cmH2O (so peep will reach 20), held for 30 s , then PEEP will be gradually reduced at intervals of 5 cmH2O down to 5 cmH2O, when initial volume control ventilation will be resumed. In the incremental PEEP group, PEEP was increased stepwise by 5 cmH₂O every 3-5 breaths until a peak airway pressure of 30 cmH₂O was achieved, after which mechanical ventilation was resumed with maintenance PEEP. The total duration of the recruitment maneuver was approximately 60-90 seconds.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Anesthesiologists (ASA) physical status II, of either sex Age ≥18 y.
  • Undergoing laparoscopic bariatric surgeries; sleeve gastrectomy, mini gastric bypass
  • BMI (35-60)

排除标准

  • Pre-existing severe pulmonary disease
  • Baseline hypoxemia SpO₂ <92% on room air
  • History of barotrauma
  • Previous pneumothorax
  • Known pulmonary bullae or emphysematous blebs

研究组 & 干预措施

group SI

Active Comparator

receive 30 cmH₂O sustained inflation for 30seconds

干预措施: sustained inflation recruitement (Procedure)

group IP

Active Comparator

receive PEEP was increased stepwise by 5 cmH₂O every 3-5 breaths until a peak airway pressure of 30 cmH₂O

干预措施: Stepwise PEEP (Procedure)

结局指标

主要结局

Postoperative lung aeration

时间窗: in the post-anesthesia care unit 15 minutes after extubation

limited-zone lung ultrasound scoring system

次要结局

  • Postoperative oxygenation(in the post-anesthesia care unit 15 minutes after extubation)
  • Oxygen requirement in PACU(in the post-anesthesia care unit 15 minutes after extubation)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Amr Fouad

Assistant Professor

Ain Shams University

研究点 (1)

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