Lung and Diaphragm-Protective Ventilation by Means of Assessing Respiratory Work
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Rate of patients achieving and maintaining LDPV targets
研究概览
简要总结
This study is designed to test a proposed strategy for lung- and diaphragm-protective ventilation (LDPV) in patients with acute hypoxemic respiratory failure. Ventilation and sedation will be titrated to evaluate whether it is feasible and safe within this patient population.
详细描述
Lung injury and diaphragm injury incurred by mechanical ventilation have very serious adverse effects on patients with acute respiratory failure. Lung injury results from excessive mechanical stress and strain applied to the lung by the ventilator and/or respiratory muscles, while diaphragm injury results from either insufficient or excessive inspiratory effort.
The objective of this study is to investigate a new LDPV strategy designed to prevent both disuse-mediated and load-induced diaphragm injury, while also preventing excess global and regional mechanical stress and strain in the injured lung. To achieve these goals, the following specific targets to be met are: (1) respiratory muscle effort similar to that of healthy subjects breathing at rest, (2) lung stress within safe limits, and (3) clinically acceptable gas exchange.
Targets are assessed through measurements of global lung stress, tidal recruitment, inspiratory effort, diaphragm contractile effort and adequacy of respiratory muscle and systemic tissue perfusion. Measurements commence at enrollment and continue for 24 hours consecutively.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with acute hypoxemic respiratory failure
- •PaO2:FiO2 ratio less than or equal to 300 mm Hg at time of screening
- •Oral endotracheal intubation and mechanical ventilation
- •Bilateral airspace opacities on chest radiograph or chest CT scan
排除标准
- •Liberation from mechanical ventilation is anticipated within 24 hours
- •Intubated for traumatic brain injury or stroke
- •Contraindication to esophageal catheterization
- •Intracranial hypertension
研究组 & 干预措施
Lower PEEP
Lung- and Diaphragm-Protective Ventilation - PEEP will be set at 8 cm H2O
干预措施: Lung- and Diaphragm-Protective Ventilation (Procedure)
Higher PEEP
Lung- and Diaphragm-Protective Ventilation - PEEP will be titrated to achieve end-expiratory PL = 2-3 cm H20 and at least 5 cm H2O greater than the level applied in the lower PEEP arm
干预措施: Lung- and Diaphragm-Protective Ventilation (Procedure)
结局指标
主要结局
Rate of patients achieving and maintaining LDPV targets
时间窗: Assessed after achievement of LDPV targets for 24 hours
次要结局
- Inspiratory effort at low and high sweep gas flow rates(Assessed 10 minutes after PEEP and sedation are adjusted)
- Inspiratory effort at lower and higher PEEP levels(Assessed 10 minutes after PEEP and sedation are adjusted)
- Accuracy of artificial intelligence model in predicting patient outcomes(Assessed after completing the 24-hour maintenance period)
- Expiratory diaphragmatic effort at lower and higher PEEP levels(Assessed 10 minutes after PEEP and sedation are adjusted)
- Sedative infusion rate at low and high sweep gas flow rates(Assessed 10 minutes after PEEP and sedation are adjusted)
- Lung stress and strain at low and high sweep gas flow rates(Assessed 10 minutes after PEEP and sedation are adjusted)