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临床试验/NCT05670483
NCT05670483招募中不适用

Use of Airway Pressure Release Ventilation in Morbidly Obese Patients Undergoing Open Heart Surgery to Improve Post Operative Pulmonary Outcomes

Ain Shams University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年12月3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
60
试验地点
2
主要终点
Time of mechanical ventilation

研究概览

简要总结

The goal of this Randomized Clinical trial is to to investigate if the use of Air Pressure Release Ventilation in morbidly obese patients undergoing open heart surgery will improve post operative pulmonary outcomes 60 Patients will be randomized into two groups according to the mode of ventilation used into: Group A: airway pressure release ventilation (APRV) group (30 Patients) Group B: Standard (control) group (30 Patients) Post-operatively, Patients will be ventilated with conventional Synchronized Intermittent Mandatory Ventilation (SIMV) volume control mode

详细描述

Obesity is an ongoing worldwide problem, and as such, weight-related issues arise especially in the intensive care unit (ICU). Morbid obesity adversely affects physiology; restricted thoracic movement and increased intra-abdominal pressure leads to reduced lung volumes and compliance resulting frequently in atelectasis, ventilation-perfusion mismatch.

Cardiac surgical patients are at particular risk for PPCs. The use of cardiopulmonary bypass (CPB) is responsible for a systemic inflammatory response and oxidative stress, leading to pulmonary ischemia-reperfusion injury. Mechanical ventilation frequently is disrupted during CPB, thus inducing atelectasis. Some proposed mechanisms are leukocyte activation, fluid accumulation in the lung and atelectasis.

Atelectasis is a highly prevalent pulmonary complication in patients undergoing cardiac surgery with cardiopulmonary bypass (CPB) and an important cause of postoperative hypoxemia. Pulmonary collapse occurs early after the induction of anesthesia and persists for several days postoperatively. Studies based on thoracic computed tomography (CT) have shown that pulmonary collapse is mainly distributed to the dependent regions close to the diaphragm and may encompass up to 35% of the overall lung parenchyma which predispose to pneumonia.

This impairment of lung function, particularly oxygenation of the blood, is a common and potentially serious complication after cardiac surgery. It has been shown to persist for as long as one week after the operation.

In obese patients, the functional residual capacity (FRC) and lung compliance are reduced, and thus the elastic work of breathing (WOB) is elevated. By applying continuous positive airway pressure (CPAP), the FRC is restored, and inspiration starts from a more favorable pressure-volume relationship, facilitating spontaneous ventilation, and improves oxygenation.

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

入选标准

  • Age ≥18 y.
  • Scheduled for open heart Surgery with cardiopulmonary bypass (CPB) pump.
  • Class III Obesity (Morbid obesity): BMI ≥ 40.0 kg/m².

排除标准

  • Patients with obstructive lung disease (asthma or chronic obstructive pulmonary disease).
  • Pneumothorax or Surgical emphysema.
  • Mechanical ventilation prior to the operation.
  • Patient Refusal.

结局指标

主要结局

Time of mechanical ventilation

时间窗: up to 3 days

Hours of Mechanical ventilation

PO2/FIO2 (P/F) ratio

时间窗: up to 3 days

Will be recorded at admission, 6 hours,12 hours, 24 hours and 48 hours

次要结局

  • Occurrence Respiratory complications(up to 1 week)
  • length of ICU stay(up to 3 days)
  • Need for Non-Invasive ventilation (NIV)(up to 3 days)
  • Need for Vasopressors and Inotropes(up to 1 day)
  • length of Hospital stay(up to 10 days)
  • Mortality(up to 30 days)
  • Effect on Blood pressure(up to 1 day)

研究者

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

Mohamed Alaaeldin Abdelmoneem Alhadidy

Principal Investigator

Ain Shams University

研究点 (2)

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