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Physiological Effects of HFNC During Exercise in Patients With Fibrosing Interstitial Lung Diseases

Study Purpose

in this study, the investigators aim to describe the effects of highflow nasal canulae oxygen therapy (HFNC) on respiratory muscle function during exercise in patients with fibrosing interstitial lung diseases (ILD) during an endurance test

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:

- Cared for as part of a respiratory rehabilitation program (ADIR association) - Presenting diffuse fibrosing interstitial pneumonitis, documented by CT scan data and whatever its etiology.

- Presenting severe hypoxemia in ambient air (SpO2<90%) during an exercise test (6-minute walk test or functional exercise test)
Exclusion Criteria:
- Patient with a contraindication to carrying out a respiratory rehabilitation program.

- Patient having presented an exacerbation of PID, pneumothorax or pneumomediastinum in the 3 months preceding potential inclusion.

- Tracheostomized patient.

- Patient with a contraindication to the placement of a nasogastric tube.

- Pregnant or breastfeeding women or women of childbearing age without effective means of contraception (a pregnancy test will be carried out) - Protected adult patient (guardianship or curatorship) - Patient deprived of liberty by court or administrative decision.

- Refusal of patient participation or consent

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.	NCT05372926
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	ADIR Association
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	France
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Interstitial Lung Disease, Pulmonary Rehabilitation

Arms & Interventions

Arms

Experimental: Venturi mask

Patients will be placed under oxygen therapy with Venturi mask at a constant flow of 15L/min and a set FiO2 of 50%. The real FiO2 will be mesured in the mask at rest.

Experimental: High flow nasal canulae

Patients will be placed under high flow nasal canulae oxygen therapy with a constant flow of 50L/min and the real FiO2 provided by Venturi mask.

Interventions

Device: - high flow nasal canulae

high flow nasal canulae is a oxygen therapy technic which allows the administration of warmed and humidified oxygen with a flow up to 50L/Min and a monitored FiO2. Physiological previous studies reported various effects of this technic especially on work of breathing. In our study the investigators aim to test this physiological property during exercise.

Device: - Ventury mask

Ventury mask is a oxygen therapy technic which allows the administration with a mask of oxygen with a flow up to 15L/Min and a monitored FiO2.

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.