NIV Versus HFO for Acute Exacerbations of Interstitial Lung Diseases
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorADIR Association
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Crossover
Treatments tested in this trial
Noninvasive mechanical ventilation
DeviceNoninvasive mechanical ventilation is a respiratory technique which allows the administration of positive inspiratory and expiratory airway pressures in order to ventilate the lungs.
Nasal high-flow oxygen therapy
DeviceNasal high-flow is a respiratory technique which allows the administration of warmed and humidified air, associated with oxygen.
Continuous positive airway pressure
DeviceContinuous positive airway pressure is a respiratory technique which allows to maintain a constant positive airway pressure during inspiration and expiration.
Treatment groups
18 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Group A: NIV + CPAP + HFOExperimental treatment 3 interventions
Group B: NIV + HFO + CPAPExperimental treatment 3 interventions
Group C: CPAP + NIV + HFOExperimental treatment 3 interventions
Group D: CPAP + HFO + NIVExperimental treatment 3 interventions
Group E: HFO + CPAP + NIVExperimental treatment 3 interventions
Group F: HFO + NIV + CPAPExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Pulmonary compliance
Comparison of global pulmonary compliance (Cglob) under noninvasive ventilation (NIV) and high-flow oxygen therapy (HFO) during acute respiratory failure in diffuse interstitial pneumonia.
Time frame
During the intervention, after an exposure of 30 minutes to the oxygen therapy deviceSecondary outcomes
1
Pulmonary compliance
Comparison of global pulmonary compliance (Cglob) under NIV and continuous positive airway pressure (CPAP) during acute respiratory failure in diffuse interstitial pneumonia.
Time frame
During the intervention, after an exposure of 30 minutes to the oxygen therapy device2
Pulmonary compliance
Comparison of global pulmonary compliance (Cglob) under HFO and CPAP during acute respiratory failure in diffuse interstitial pneumonia.
Time frame
During the intervention, after an exposure of 30 minutes to the oxygen therapy device3
Pulmonary compliance
Comparison of global pulmonary compliance (Cglob) under HFO and face mask oxygen therapy (FM) during acute respiratory failure in diffuse interstitial pneumonia.
Time frame
During the intervention, after an exposure of 30 minutes to the oxygen therapy device4
Pulmonary compliance
Comparison of global pulmonary compliance (Cglob) under NIV and face mask oxygen therapy (FM) during acute respiratory failure in diffuse interstitial pneumonia.
Time frame
During the intervention, after an exposure of 30 minutes to the oxygen therapy deviceSponsors and contacts
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Source ClinicalTrials.gov
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