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临床试验/NCT06494410
NCT06494410已完成不适用

Comparison of the Effect of High Versus Low Fraction of Inspired Oxygen During Alveolar Recruitment on Absorption Atelectasis in Laparoscopic Bariatric Surgery Patients With Atelectasis

Egymedicalpedia1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2023年2月7日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
1
主要终点
Modified Lung Ultrasound Score (LUSS)

研究概览

简要总结

Intraoperative absorption atelectasis is associated with decreased lung compliance, impaired oxygenation, increased pulmonary vascular resistance, and lung injury.

The alveolar recruitment maneuver (RM) with positive-end expiratory pressure (PEEP) has been advocated as efficient for absorption atelectasis treatment.

During general anesthesia, absorption atelectasis reportedly occurs in most patients especially during laparoscopic surgery, the increased abdominal pressure of capnoperitoneum may shift the diaphragm cranially and decrease respiratory compliance

详细描述

The incidence of obesity (defined by a body mass index (BMI) > 30 kg/m2) is increasing worldwide. In selected individuals, bariatric surgery may offer means of achieving long-term weight loss, improved health, and healthcare cost reduction. Physiological changes that occur because of obesity and general anesthesia predispose to respiratory complications following bariatric surgery.

Obesity affects many respiratory functions, including, among others, a reduction in functional residual capacity, an increase in airway resistance, and a high level of ventilation-perfusion mismatch. The combination of obesity and postoperative respiratory muscle dysfunction could promote respiratory failure.

Absorption atelectasis occurs in most patients, typically due to absorption of gas, compression of the lung tissue, and impairment of surfactant function. Additionally, during laparoscopic surgery, the increased abdominal pressure of capnoperitoneum may shift the diaphragm cranially and decrease respiratory compliance.

Compression of basal lung regions due to a stiffened diaphragm would accelerate the formation of absorption atelectasis that was already initiated during anesthesia induction.

Such deterioration is associated with pulmonary densities revealed by computed tomography. In addition to physiologic impairment, atelectasis could contribute to perioperative lung injury and PPC.

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
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients aged between 18 - 60 years old.
  • •Both genders.
  • •Preoperative Physical Status: ASA II, III Patients.
  • •BMI above 40 Kg/m
  • •Patients undergoing laparoscopic bariatric surgeries: laparoscopic mini gastric bypass, Roux-en-Y gastric bypass and revision bariatric surgery (redo bariatric surgery) with the presence of atelectasis confirmed radiologically by Chest X-ray (CXR) and CT Chest

排除标准

  • •Refusal of the intervention or participation in the study.
  • •Patient under age of 18 years old or above 60 years old.
  • •Preoperative Physical Status: ASA I, IV.
  • •Psychiatric illness.
  • •Known cases of chronic pulmonary disease e.g. COPD and bronchial asthma.
  • •Known cases of cardiac diseases.
  • •Previous lung surgery.
  • •Lactation.

研究组 & 干预措施

High Fraction of Inspired Oxygen(Group A)

Active Comparator

About 40 patients received FiO2 1.0 during recruitment maneuvers

干预措施: High versus Low Fraction of Inspired Oxygen (Procedure)

Low Fraction of Inspired Oxygen(Group B)

Active Comparator

About 40 patients received FiO2 0.4 during recruitment maneuvers

干预措施: High versus Low Fraction of Inspired Oxygen (Procedure)

结局指标

主要结局

Modified Lung Ultrasound Score (LUSS)

时间窗: from 0 hours to 6 hours after the procedure

1\. Modified LUSS at surgery completion compared to baseline preoperative modified LUSS, reflecting any aeration loss during general anesthesia.

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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