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NIV Versus HFO for Acute Exacerbations of Interstitial Lung Diseases

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06182956
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	ADIR Association
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Elise ARTAUD-MACARI, MD
Principal Investigator Affiliation	Rouen University Hospital
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries	France
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Interstitial Lung Disease, Acute Respiratory Failure

Arms & Interventions

Arms

Experimental: NIV + CPAP + HFO

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.

Experimental: NIV + HFO + CPAP

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.

Experimental: CPAP + NIV + HFO

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.

Experimental: CPAP + HFO + NIV

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.

Experimental: HFO + CPAP + NIV

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.

Experimental: HFO + NIV + CPAP

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.

Interventions

Device: - Noninvasive 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.

Device: - Nasal high-flow oxygen therapy

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

Device: - Continuous positive airway pressure

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.