NCT06182956尚未招募不适用
Evaluation of Physiological Effects of Noninvasive Mechanical Ventilation and High-flow Oxygen Therapy for Acute Exacerbations of Interstitial Lung Diseases
ADIR Association2 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2024年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Pulmonary compliance
研究概览
简要总结
The objectives of this study are to compare the physiological consequences of high-flow oxygen therapy and noninvasive mechanical ventilation on ventilation, respiratory work and hemodynamics during acute respiratory failure in diffuse interstitial pneumonia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 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
- •Age > 18 yrs
- •Hospitalization in intensive care unit
- •Acute exacerbation of a previously/presently documented diffuse (fibrotic) interstitial lung disease
- •Dyspnea majoration since at least 1 month
- •Alveolar or ground-glass opacities on CT-scan that are superposed to interstitial lung disease and not explained by left heart failure or volume overload
- •Hypoxemia requiring oxygen flows > 6 L/min
排除标准
- •Contraindication to noninvasive ventilation or high-flow oxygen therapy
- •Immediate indication to endotracheal intubation or hemodynamic assistance
- •Body mass index > 40
- •Presence of a pacemaker or an implantable defibrillator
- •Presence of cutaneous lesions where Pulmovista® belt should be placed
- •Moribund patient
- •Pregnant or breastfeeding women or women of childbearing age without an effective method of contraception
- •Protected adult patient (tutorship or curatorship)
- •Patient deprived of liberty by court or administrative decision
- •No possibility to install nasogastric tube
- •Endotracheal or tracheostomy tube requirement during the study
- •Hemodynamic assistance requirement during the study
结局指标
主要结局
Pulmonary compliance
时间窗: During the intervention, after an exposure of 30 minutes to the oxygen therapy device
Comparison of global pulmonary compliance (Cglob) under noninvasive ventilation (NIV) and high-flow oxygen therapy (HFO) during acute respiratory failure in diffuse interstitial pneumonia.
次要结局
- transpulmonary pressure(During the intervention, after an exposure of 30 minutes to the oxygen therapy device)
- ultrasound diaphragmatic strain.(During the intervention, after an exposure of 30 minutes to the oxygen therapy device)
- diaphragmatic thickening fraction(During the intervention, after an exposure of 30 minutes to the oxygen therapy device)
- Systolic arterial pressures(During the intervention, after an exposure of 30 minutes to the oxygen therapy device)
- peak inspiratory flow(During the intervention, after an exposure of 30 minutes to the oxygen therapy device)
- oesophagal pressure time products(During the intervention, after an exposure of 30 minutes to the oxygen therapy device)
- peak expiratory flow(During the intervention, after an exposure of 30 minutes to the oxygen therapy device)
- Diastolic arterial pressures(During the intervention, after an exposure of 30 minutes to the oxygen therapy device)
- Mean arterial pressure(During the intervention, after an exposure of 30 minutes to the oxygen therapy device)
- systolic pulmonary arterial pressure(During the intervention, after an exposure of 30 minutes to the oxygen therapy device)
- tricuspid annular plane systolic excursion(During the intervention, after an exposure of 30 minutes to the oxygen therapy device)
- right ventricular strain(During the intervention, after an exposure of 30 minutes to the oxygen therapy device)
- left ventricular ejection fraction(During the intervention, after an exposure of 30 minutes to the oxygen therapy device)
- E/E' ratio(During the intervention, after an exposure of 30 minutes to the oxygen therapy device)
- right auricular pressure(During the intervention, after an exposure of 30 minutes to the oxygen therapy device)
- cardiac output(During the intervention, after an exposure of 30 minutes to the oxygen therapy device)
- heart rate(During the intervention, after an exposure of 30 minutes to the oxygen therapy device)
- Pulsed oxymetry(During the intervention, after an exposure of 30 minutes to the oxygen therapy device)
- transcutaneous carbon dioxide pressure(During the intervention, after an exposure of 30 minutes to the oxygen therapy device)
- Dyspnea(During the intervention, after an exposure of 30 minutes to the oxygen therapy device)
- Comparison of Comfort(During the intervention, after an exposure of 30 minutes to the oxygen therapy device)
- Pulmonary compliance(During the intervention, after an exposure of 30 minutes to the oxygen therapy device)
- Tidal volume(During the intervention, after an exposure of 30 minutes to the oxygen therapy device)
- end-expiratory lung volume(During the intervention, after an exposure of 30 minutes to the oxygen therapy device)
- driving pressure(During the intervention, after an exposure of 30 minutes to the oxygen therapy device)
- Global inhomogeneity index(During the intervention, after an exposure of 30 minutes to the oxygen therapy device)
- respiratory rate(During the intervention, after an exposure of 30 minutes to the oxygen therapy device)
- inspiratory time(During the intervention, after an exposure of 30 minutes to the oxygen therapy device)
- oesophagal pressure swings(During the intervention, after an exposure of 30 minutes to the oxygen therapy device)
- transdiaphragmatic pressure variations(During the intervention, after an exposure of 30 minutes to the oxygen therapy device)
- transdiaphragmatic pressure time products(During the intervention, after an exposure of 30 minutes to the oxygen therapy device)
研究者
研究点 (2)
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