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临床试验/NCT06115668
NCT06115668招募中不适用

Effects of Individualized Positive End-Expiratory Pressure (PEEP) on Oxygenation, Hemodynamic Variables, and Incidence of Early Postoperative Atelectasis in Patients Undergoing Laparoscopic Bariatric Surgery: A Prospective Randomized Controlled Study

Tanta University2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2023年11月5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
80
试验地点
2
主要终点
Intraoperative oxygenation

研究概览

简要总结

The aim of this study is to evaluate the effectiveness of intraoperative individualized positive end-expiratory pressure (PEEPIND) titration, compared to fixed positive end-expiratory pressure of 5 cmH2O, on oxygenation, hemodynamic variables, and early postoperative complications in obese patients undergoing laparoscopic bariatric surgery.

详细描述

Obesity is a major health problem, and the incidence is increasing worldwide. So far, the only treatment for morbid obesity with good long-term results is bariatric surgery.

Obese patients have unique respiratory physiology and ventilatory mechanics characteristics. Their lung function is impaired due to the reduction of oxygen reserve, functional residual capacity, and lung compliance. In addition, they frequently present with respiratory comorbidities, which increases the risk of developing postoperative pulmonary complications (PPCs) such as atelectasis especially after procedures under general anesthesia. Atelectasis has been hypothesized as a main cause of postoperative hypoxemia.

To reduce the incidence of atelectasis, positive end-expiratory pressure (PEEP) and recruitment maneuvers are used as a protective lung strategy to improve gas exchange and lung mechanics through reopening collapsed alveoli and maintaining the aeration of lungs. Application of PEEP may also eliminate auto-PEEP without increasing plateau pressure.

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
None

入排标准

年龄范围
21 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age from 21 to 60 years.
  • Both sexes.
  • American Society of Anesthesiologists (ASA) physical status class I-III
  • Patients who are scheduled for elective laparoscopic bariatric surgery under general anesthesia.

排除标准

  • Patients who are unwilling to participate in the study
  • Actively smokers.
  • Patients who had a history of Chronic obstructive pulmonary disease or bronchial asthma.
  • Patients who are receiving renal replacement therapy prior to surgery.
  • Patients who had a history of heart failure.
  • Pregnant.
  • Patients who have allergies to any drug used in the study.

结局指标

主要结局

Intraoperative oxygenation

时间窗: One hour after extubation

Intraoperative oxygenation which will be assessed by P/F ratio (the ratio of arterial oxygen partial pressure (PaO2 in mmHg) to fractional inspired oxygen (FiO2 expressed as a fraction, not a percentage). PaO2/FiO2: will be measured at before induction of anesthesia, immediately after intubation, after PEEP titration, one hour after pneumoperitoneum, before extubation, one hour after extubation

次要结局

  • Mean arterial pressure(MAP)(One hour after extubation)
  • Dosage of vasopressors(Till the end of surgery)
  • Heart rate(HR)(One hour after extubation)
  • Lung ultrasound scores(12 hours postoperatively)
  • Early postoperative pulmonary complication(First 24 hours postoperatively)
  • Volume of total fluid infusion(Till the end of surgery)
  • Length of hospital stay(28 days postoperatively)

研究者

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

Heba Zakaria Mohamed Khattab

Assistant Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine

Tanta University

研究点 (2)

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