NIV Versus HFO for Acute Exacerbations of Interstitial Lung Diseases

Evaluation of Physiological Effects of Noninvasive Mechanical Ventilation and High-flow Oxygen Therapy for Acute Exacerbations of Interstitial Lung Diseases

Status

Not yet recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06182956

Acronym

IRAPIDPhysio

Enrollment

Registered

2023-12-27

Start date

2024-01-01

Completion date

2026-12-31

Last updated

2023-12-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Failure, Interstitial Lung Disease

Keywords

Noninvasive mechanical ventilation, Nasal high-flow oxygen therapy, Respiratory work, Hemodynamics, Diaphragm

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.

Interventions

DEVICENoninvasive mechanical ventilation

Noninvasive mechanical ventilation is a respiratory technique which allows the administration of positive inspiratory and expiratory airway pressures in order to ventilate the lungs.

DEVICENasal high-flow oxygen therapy

Nasal high-flow is a respiratory technique which allows the administration of warmed and humidified air, associated with oxygen.

DEVICEContinuous positive airway pressure

Continuous positive airway pressure is a respiratory technique which allows to maintain a constant positive airway pressure during inspiration and expiration.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Tidal volume	During the intervention, after an exposure of 30 minutes to the oxygen therapy device	Comparison of Tidal volume under CPAP and face mask oxygen therapy (FM) 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 NIV and CPAP during acute respiratory failure in diffuse interstitial pneumonia.
transpulmonary pressure	During the intervention, after an exposure of 30 minutes to the oxygen therapy device	Comparison of transpulmonary pressure under FM and CPAP 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 NIV and CPAP 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 CPAP and FM 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 HFO 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 NIV and CPAP 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 CPAP and HFO 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 NIV and HFO 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 HFO 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 NIV and CPAP 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 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 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 FM 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 NIV and continuous positive airway pressure (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 CPAP and HFO 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 HFO and NIV 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 NIV and CPAP 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 CPAP and NIV 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 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 CPAP 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 HFO 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 CPAP and NIV 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 HFO 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 CPAP and NIV 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 NIV and HFO 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 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 HFO and FM 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 FM and NIV 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 NIV and CPAP during acute respiratory failure in diffuse interstitial pneumonia.

Countries

France

Contacts

Primary ContactElise ARTAUD-MACARI, MD

elise.artaud-macari@chu-rouen.fr+33232885992

Backup ContactMaryline LEFORT

mlefort@adir-hautenormandie.com+33232885992

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026