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临床试验/NCT07065370
NCT07065370已完成不适用

Intra-Operative Modified Ventilator Mechanical Power as a Predictor of Postoperative Hypoxemia In Laparoscopic Bariatric Surgeries

Tanta University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年11月30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
100
试验地点
1
主要终点
Incidence of hypoxemia

研究概览

简要总结

To compare the effects of two levels of mechanical power on the incidence of post-operative hypoxemia in morbid obese patients undergoing laparoscopic bariatric surgeries.

Primary outcome: Incidence of postoperative hypoxemia within the first 24 hour after surgery.

详细描述

Postoperative pulmonary complications are estimated to occur in more than 30% of patients after major surgery and are associated with increased morbidity, mortality and healthcare costs. Therefore, it is desirable to identify potentially modifiable factors that may be associated with an increased risk of Postoperative pulmonary complications. A high tidal volume, a high driving pressure, and also a high flow and a high respiratory rate can induce lung injury. Changing one of these variables could inadvertently affect the other three variables .

Previous studies have focused on intraoperative lung-protective ventilation to prevent Postoperative pulmonary complications but have yielded equivocal results: the combination of lowering tidal volume and applying positive end-expiratory pressure, which resulted in lower driving pressures, improved postoperative pulmonary function and reduced major postoperative adverse events. Trials investigating single interventions were, however, nonconfirmatory: a single-center randomized controlled trial failed to demonstrate an effect of low (6 ml/kg) versus high tidal volumes (10 ml/kg) in patients undergoing surgery, .While tidal volume was the only randomized variable in these studies, there was an associated increase in respiratory rate, potentially offsetting the beneficial effect of lowering tidal volume. This illustrates the need for a unifying concept that integrates the effects of changes in multiple parameters when adjusting mechanical ventilation to reduce perioperative ventilator-induced lung injury .

Recently, it has been proposed that the extent of the ventilator-induced lung injury may relate to the amount of energy transferred from the ventilator to the lungs, a concept referred to as 'mechanical power . Measurement of mechanical power is determined by a combination of factors including tidal volume, inspiratory pressure, respiratory rate and inspiratory flow rate, all of which determine the amount of energy generated during mechanical ventilation.

Previous studies have demonstrated that mechanical power is associated with increased mortality in intensive care unit patients with and without Acute Respiratory Distress Syndrome . The effects of the intraoperative mechanical power on the occurrence of Postoperative pulmonary complications in abdominal surgery have not yet been investigated thoroughly. In our study, we hypothesized that decrease mechanical power of ventilator would decrease Postoperative pulmonary complications in patients undergoing laparoscopic bariatric surgery.

The purpose of the study to compare the effects of two levels of mechanical power on the incidence of post-operative hypoxemia in morbid obese patients undergoing laparoscopic bariatric surgeries

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
Single (Participant)

入排标准

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

入选标准

  • •Age 21-60 years
  • •American society of anesthesiology physical status III
  • •Body mass index ≥ 40 kg/m2 undergoing laparoscopic bariatric surgery.

排除标准

  • •Uncontrolled respiratory morbidity such as sever bronchial asthma or chronic obstructive pulmonary disease.
  • •Patients with valvular or ischemic heart diseases, or uncontrolled hypertension
  • •Patients with hepatic dysfunction or renal or endocrine disorders,
  • •Patients with history of cerebrovascular disease or uncontrolled Diabetes mellitus.
  • •Previous lung surgery
  • •Patients with neuromuscular diseases

研究组 & 干预措施

Group I

Experimental

Patient of this group received volume-controlled ventilation with tidal volume 6-8ml/kg (predicted body weight) with respiratory rate 12-14 cycle/minute.

干预措施: Group I ( volume-controlled ventilation with tidal volume 6-8ml/kg (predicted body weight) with respiratory rate 12-14 cycle/minute. (Device)

Group II

Experimental

Patient of this group received volume-controlled ventilation with tidal volume 6-8ml/kg (predicted body weight) with respiratory rate 18-20 cycle/minute

干预措施: Group II: (volume-controlled ventilation with tidal volume 6-8ml/kg ) (Device)

结局指标

主要结局

Incidence of hypoxemia

时间窗: 24 hours postoperative

次要结局

  • Correlation between the intraoperative mechanical power and postoperative hypoxemia(24 hours postoperative)

研究者

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

Ahmed Mostafa Ahmed Elbradey

Resident

Tanta University

研究点 (1)

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