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

Evaluation of the Physiological Effects of High Flow Nasal Canulae Oxygen Therapy During Exercise in Patients With Fibrosing Interstitial Lung Diseases

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05372926
Acronym
HighFlowMusc
Enrollment
16
Registered
2022-05-13
Start date
2022-11-22
Completion date
2024-11-23
Last updated
2022-11-23

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

Conditions

Interstitial Lung Disease, Pulmonary Rehabilitation

Keywords

interstitial lung disease, nasal high flow oxygen therapy, endurance test, pulmonary rehabilitation

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

Interventions

DEVICEhigh 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.

DEVICEVentury 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.

Sponsors

ADIR Association
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Ptdi swingduring the intervention, at isotimeTo compare the change in transdiaphragmatic pressure between baseline and peak during inspiration (Ptdi swing) between HFNC and VM in patients with fibrosing Interstitial Lung Disease in stable state, at isotime.

Secondary

MeasureTime frameDescription
PTPoesoduring the intervention, at isotimeon effort at isotime, comparison between HFNC and VM of the respiratory Pressure Time Product during a respiratory cycle (PTPoeso)
Poeso swingduring the intervention, at isotimeon effort at isotime, comparison between HFNC and VM of variation of oesophagal pressure between the base state and the peak (Poeso swing)
DeltaPtdi/DeltaEAdiduring the intervention, at isotimeon effort at isotime, comparison between HFNC and VM of the electromechanical coupling of the diaphragm (ratio of variation of the transdiaphragmatic pressure by the variation of electrical activity of the diaphragm (EAdi) between the start of inspiration and the end of expiration, (DeltaPtdi/DeltaEAdi)
PTPdiduring the intervention, at isotimeon effort at isotime, comparison between HFNC and VM of diaphragmatic pressure time product during a respiratory cycle (PTPdi)
TcCO2during the intervention, at isotimeon effort at isotime, comparison between HFNC and VM of transcutaneous CO2 measurement (TcCO2)
Tlimduring the intervention, at the end of endurance testComparison of endurance time (Tlim) between HFNC and VM
SmO2during the intervention, at isotimeon effort at isotime, comparison between HFNC and VM of the measurement of tissue saturation in oxygen (SmO2) by Near Infrared Spectrometry (NIRS)

Countries

France

Contacts

Primary ContactElise ARTAUD-MACARI, MD
eliseartaudmacari@yahoo.fr+3332 88 59 92
Backup ContactMaryline LEFORT
mlefort@adir-hautenormandie.com+3332 88 59 92

Outcome results

None listed

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