Clinical trial NCT05372926: Physiological Effects of HFNC During Exercise in Patients With Fibrosing Interstitial Lung Diseases
Official title: Evaluation of the Physiological Effects of High Flow Nasal Canulae Oxygen Therapy During Exercise in Patients With Fibrosing Interstitial Lung Diseases
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Interstitial Lung Disease
Pulmonary Rehabilitation
Keywords: interstitial lung disease
nasal high flow oxygen therapy
endurance test
pulmonary rehabilitation
Lead sponsor: ADIR Association
Sponsor class: OTHER
First posted: 2022-05-13
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: All patients were randomly allocated into two groups using the block randomization technique (blocks of eight patients) in a 1:1 ratio. In group A, a high-intensity constant work-rate endurance test using Venturi mask (VM) was performed on first, and a test using high-flow nasal canulae oxygen therapy (HFNC) was performed next. In group B, a high-intensity CWRET using HFNC was performed first, and a test using VM was performed next.
Primary purpose: TREATMENT

Brief summary: 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


Eligibility 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

Primary outcomes:
measure: Ptdi swing
timeFrame: during the intervention, at isotime
Secondary outcomes:
measure: PTPdi
timeFrame: during the intervention, at isotime
measure: PTPoeso
timeFrame: during the intervention, at isotime
measure: Poeso swing
timeFrame: during the intervention, at isotime
measure: DeltaPtdi/DeltaEAdi
timeFrame: during the intervention, at isotime
measure: SmO2
timeFrame: during the intervention, at isotime
measure: TcCO2
timeFrame: during the intervention, at isotime
measure: Tlim
timeFrame: during the intervention, at the end of endurance test
Other outcomes:
Locations:
city: Bois-Guillaume
country: France
facility: ADIR association
Study officials:
affiliation: ADIR Association
name: Elise ARTAUD-MACARI, MD
role: PRINCIPAL_INVESTIGATOR
References: