NIV Versus HFO for Acute Exacerbations of Interstitial Lung Diseases
- Conditions
- Acute Respiratory FailureInterstitial Lung Disease
- Interventions
- Device: Noninvasive mechanical ventilationDevice: Nasal high-flow oxygen therapyDevice: Continuous positive airway pressure
- Registration Number
- NCT06182956
- Lead Sponsor
- ADIR Association
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 18
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description NIV + CPAP + HFO Nasal high-flow oxygen therapy The patient will be placed under noninvasive mechanical ventilation during 30 min, then continuous positive airway pressure during 30 min and then nasal high-flow oxygen during 30 min. Each period will be separated by a washout period of maximum 30 min under oxygen with a non-rebreathing mask. HFO + NIV + CPAP Continuous positive airway pressure The patient will be placed under nasal high-flow oxygen during 30 min, then noninvasive mechanical ventilation during 30 min and then continuous positive airway pressure during 30 min. Each period will be separated by a washout period of maximum 30 min under oxygen with a non-rebreathing mask. CPAP + NIV + HFO Continuous positive airway pressure The patient will be placed under continuous positive airway pressure during 30 min, then noninvasive mechanical ventilation during 30 min and then nasal high-flow oxygen during 30 min. Each period will be separated by a washout period of maximum 30 min under oxygen with a non-rebreathing mask. HFO + NIV + CPAP Nasal high-flow oxygen therapy The patient will be placed under nasal high-flow oxygen during 30 min, then noninvasive mechanical ventilation during 30 min and then continuous positive airway pressure during 30 min. Each period will be separated by a washout period of maximum 30 min under oxygen with a non-rebreathing mask. NIV + HFO + CPAP Noninvasive mechanical ventilation The patient will be placed under noninvasive mechanical ventilation during 30 min, then nasal high-flow oxygen during 30 min and then continuous positive airway pressure during 30 min. Each period will be separated by a washout period of maximum 30 min under oxygen with a non-rebreathing mask. HFO + NIV + CPAP Noninvasive mechanical ventilation The patient will be placed under nasal high-flow oxygen during 30 min, then noninvasive mechanical ventilation during 30 min and then continuous positive airway pressure during 30 min. Each period will be separated by a washout period of maximum 30 min under oxygen with a non-rebreathing mask. NIV + CPAP + HFO Noninvasive mechanical ventilation The patient will be placed under noninvasive mechanical ventilation during 30 min, then continuous positive airway pressure during 30 min and then nasal high-flow oxygen during 30 min. Each period will be separated by a washout period of maximum 30 min under oxygen with a non-rebreathing mask. NIV + HFO + CPAP Nasal high-flow oxygen therapy The patient will be placed under noninvasive mechanical ventilation during 30 min, then nasal high-flow oxygen during 30 min and then continuous positive airway pressure during 30 min. Each period will be separated by a washout period of maximum 30 min under oxygen with a non-rebreathing mask. NIV + HFO + CPAP Continuous positive airway pressure The patient will be placed under noninvasive mechanical ventilation during 30 min, then nasal high-flow oxygen during 30 min and then continuous positive airway pressure during 30 min. Each period will be separated by a washout period of maximum 30 min under oxygen with a non-rebreathing mask. CPAP + HFO + NIV Noninvasive mechanical ventilation The patient will be placed under continuous positive airway pressure during 30 min, then nasal high-flow oxygen during 30 min and then noninvasive mechanical ventilation during 30 min. Each period will be separated by a washout period of maximum 30 min under oxygen with a non-rebreathing mask. CPAP + HFO + NIV Continuous positive airway pressure The patient will be placed under continuous positive airway pressure during 30 min, then nasal high-flow oxygen during 30 min and then noninvasive mechanical ventilation during 30 min. Each period will be separated by a washout period of maximum 30 min under oxygen with a non-rebreathing mask. HFO + CPAP + NIV Noninvasive mechanical ventilation The patient will be placed under nasal high-flow oxygen during 30 min, then continuous positive airway pressure during 30 min and then noninvasive mechanical ventilation during 30 min. Each period will be separated by a washout period of maximum 30 min under oxygen with a non-rebreathing mask. HFO + CPAP + NIV Continuous positive airway pressure The patient will be placed under nasal high-flow oxygen during 30 min, then continuous positive airway pressure during 30 min and then noninvasive mechanical ventilation during 30 min. Each period will be separated by a washout period of maximum 30 min under oxygen with a non-rebreathing mask. NIV + CPAP + HFO Continuous positive airway pressure The patient will be placed under noninvasive mechanical ventilation during 30 min, then continuous positive airway pressure during 30 min and then nasal high-flow oxygen during 30 min. Each period will be separated by a washout period of maximum 30 min under oxygen with a non-rebreathing mask. CPAP + NIV + HFO Noninvasive mechanical ventilation The patient will be placed under continuous positive airway pressure during 30 min, then noninvasive mechanical ventilation during 30 min and then nasal high-flow oxygen during 30 min. Each period will be separated by a washout period of maximum 30 min under oxygen with a non-rebreathing mask. CPAP + NIV + HFO Nasal high-flow oxygen therapy The patient will be placed under continuous positive airway pressure during 30 min, then noninvasive mechanical ventilation during 30 min and then nasal high-flow oxygen during 30 min. Each period will be separated by a washout period of maximum 30 min under oxygen with a non-rebreathing mask. CPAP + HFO + NIV Nasal high-flow oxygen therapy The patient will be placed under continuous positive airway pressure during 30 min, then nasal high-flow oxygen during 30 min and then noninvasive mechanical ventilation during 30 min. Each period will be separated by a washout period of maximum 30 min under oxygen with a non-rebreathing mask. HFO + CPAP + NIV Nasal high-flow oxygen therapy The patient will be placed under nasal high-flow oxygen during 30 min, then continuous positive airway pressure during 30 min and then noninvasive mechanical ventilation during 30 min. Each period will be separated by a washout period of maximum 30 min under oxygen with a non-rebreathing mask.
- Primary Outcome Measures
Name Time Method Pulmonary compliance 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.
- Secondary Outcome Measures
Name Time Method transpulmonary pressure During the intervention, after an exposure of 30 minutes to the oxygen therapy device Comparison of transpulmonary pressure under NIV and CPAP during acute respiratory failure in diffuse interstitial pneumonia.
end-expiratory lung volume During the intervention, after an exposure of 30 minutes to the oxygen therapy device Comparison of end-expiratory lung volume under FM and CPAP during acute respiratory failure in diffuse interstitial pneumonia.
respiratory rate During the intervention, after an exposure of 30 minutes to the oxygen therapy device Comparison of respiratory rate under NIV and CPAP during acute respiratory failure in diffuse interstitial pneumonia.
inspiratory time During the intervention, after an exposure of 30 minutes to the oxygen therapy device Comparison of inspiratory time under CPAP and HFO during acute respiratory failure in diffuse interstitial pneumonia.
ultrasound diaphragmatic strain. During the intervention, after an exposure of 30 minutes to the oxygen therapy device Comparison of ultrasound diaphragmatic strain under HFO and CPAP during acute respiratory failure in diffuse interstitial pneumonia.
diaphragmatic thickening fraction During the intervention, after an exposure of 30 minutes to the oxygen therapy device Comparison of diaphragmatic thickening fraction under NIV and CPAP during acute respiratory failure in diffuse interstitial pneumonia.
Pulmonary compliance During the intervention, after an exposure of 30 minutes to the oxygen therapy device Comparison of global pulmonary compliance (Cglob) under CPAP and face mask oxygen therapy (FM) during acute respiratory failure in diffuse interstitial pneumonia.
oesophagal pressure swings During the intervention, after an exposure of 30 minutes to the oxygen therapy device Comparison of oesophagal pressure variations between inspiration and expiration under NIV and HFO during acute respiratory failure in diffuse interstitial pneumonia.
Tidal volume During the intervention, after an exposure of 30 minutes to the oxygen therapy device Comparison of Tidal volume under NIV and CPAP during acute respiratory failure in diffuse interstitial pneumonia.
oesophagal pressure time products During the intervention, after an exposure of 30 minutes to the oxygen therapy device Comparison of oesophagal pressure time products under HFO and CPAP during acute respiratory failure in diffuse interstitial pneumonia.
cardiac output During the intervention, after an exposure of 30 minutes to the oxygen therapy device Comparison of cardiac output under CPAP and NIV during acute respiratory failure in diffuse interstitial pneumonia.
heart rate During the intervention, after an exposure of 30 minutes to the oxygen therapy device Comparison of heart rate under NIV and HFO during acute respiratory failure in diffuse interstitial pneumonia.
driving pressure During the intervention, after an exposure of 30 minutes to the oxygen therapy device Comparison of driving pressure under CPAP and FM during acute respiratory failure in diffuse interstitial pneumonia.
Global inhomogeneity index During the intervention, after an exposure of 30 minutes to the oxygen therapy device Comparison of Global inhomogeneity index under HFO and CPAP during acute respiratory failure in diffuse interstitial pneumonia.
Systolic arterial pressures During the intervention, after an exposure of 30 minutes to the oxygen therapy device Comparison of Systolic arterial pressures under CPAP and HFO during acute respiratory failure in diffuse interstitial pneumonia.
systolic pulmonary arterial pressure During the intervention, after an exposure of 30 minutes to the oxygen therapy device Comparison of systolic pulmonary arterial pressure under CPAP and NIV during acute respiratory failure in diffuse interstitial pneumonia.
tricuspid annular plane systolic excursion During the intervention, after an exposure of 30 minutes to the oxygen therapy device Comparison of tricuspid annular plane systolic excursion under HFO and NIV during acute respiratory failure in diffuse interstitial pneumonia.
transdiaphragmatic pressure variations During the intervention, after an exposure of 30 minutes to the oxygen therapy device Comparison of transdiaphragmatic pressure variations between inspiration and expiration under HFO and CPAP during acute respiratory failure in diffuse interstitial pneumonia.
peak inspiratory flow During the intervention, after an exposure of 30 minutes to the oxygen therapy device Comparison of peak inspiratory flow under FM and CPAP during acute respiratory failure in diffuse interstitial pneumonia.
Diastolic arterial pressures During the intervention, after an exposure of 30 minutes to the oxygen therapy device Comparison of Diastolic arterial pressures under HFO and NIV during acute respiratory failure in diffuse interstitial pneumonia.
Mean arterial pressure During the intervention, after an exposure of 30 minutes to the oxygen therapy device Comparison of Mean arterial pressures under NIV and CPAP during acute respiratory failure in diffuse interstitial pneumonia.
Pulsed oxymetry During the intervention, after an exposure of 30 minutes to the oxygen therapy device Comparison of pulsed oxymetry under CPAP and HFO during acute respiratory failure in diffuse interstitial pneumonia.
Dyspnea During the intervention, after an exposure of 30 minutes to the oxygen therapy device Comparison of Borg's scale (from 0 to 10, 10 is maximal dyspnea) under FM and NIV during acute respiratory failure in diffuse interstitial pneumonia.
Comparison of Comfort During the intervention, after an exposure of 30 minutes to the oxygen therapy device Visual comfort scale (from 0 to 10, 10 is maximal confort) under HFO and NIV during acute respiratory failure in diffuse interstitial pneumonia.
transdiaphragmatic pressure time products During the intervention, after an exposure of 30 minutes to the oxygen therapy device Comparison of transdiaphragmatic pressure time products under NIV and CPAP during acute respiratory failure in diffuse interstitial pneumonia.
peak expiratory flow During the intervention, after an exposure of 30 minutes to the oxygen therapy device Comparison of peak expiratory flow under HFO and NIV during acute respiratory failure in diffuse interstitial pneumonia.
left ventricular ejection fraction During the intervention, after an exposure of 30 minutes to the oxygen therapy device Comparison of left ventricular ejection fraction under HFO and NIV during acute respiratory failure in diffuse interstitial pneumonia.
E/E' ratio During the intervention, after an exposure of 30 minutes to the oxygen therapy device Comparison of E/E' ratio under CPAP and NIV during acute respiratory failure in diffuse interstitial pneumonia.
right auricular pressure During the intervention, after an exposure of 30 minutes to the oxygen therapy device Comparison of right auricular pressure under HFO and NIV during acute respiratory failure in diffuse interstitial pneumonia.
transcutaneous carbon dioxide pressure During the intervention, after an exposure of 30 minutes to the oxygen therapy device Comparison of transcutaneous carbon dioxide pressure under HFO and FM during acute respiratory failure in diffuse interstitial pneumonia.
right ventricular strain During the intervention, after an exposure of 30 minutes to the oxygen therapy device Comparison of right ventricular strain under CPAP and NIV during acute respiratory failure in diffuse interstitial pneumonia.
Trial Locations
- Locations (1)
ADIR Association
🇫🇷Rouen, France