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

NCT05372926 | Unknown

• 1 other identifier: HighFlowMusc
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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

Conditions

Interstitial Lung Disease; Pulmonary Rehabilitation

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Ptdi swing

  To 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.

  during the intervention, at isotime

Secondary Outcomes (7)

• PTPdi

  during the intervention, at isotime

• PTPoeso

  during the intervention, at isotime

• Poeso swing

  during the intervention, at isotime

• DeltaPtdi/DeltaEAdi

  during the intervention, at isotime

• SmO2

  during the intervention, at isotime

Study Arms (2)

Venturi mask

EXPERIMENTAL

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.

Device: Ventury mask

High flow nasal canulae

EXPERIMENTAL

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.

Device: high flow nasal canulae

Interventions

high flow nasal canulae DEVICE

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.

High flow nasal canulae

Ventury mask DEVICE

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.

Venturi mask

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Patient with a contraindication to carrying out a respiratory rehabilitation program
• 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

Sponsors & Collaborators

• ADIR Association: lead

Study Sites (1)

ADIR association

Bois-Guillaume, 76230, France

RECRUITING

MeSH Terms

Conditions

Lung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Study Officials

• Elise ARTAUD-MACARI, MD

  ADIR Association

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elise ARTAUD-MACARI, MD

CONTACT

+3332 88 59 92; eliseartaudmacari@yahoo.fr

Maryline LEFORT

CONTACT

+3332 88 59 92; mlefort@adir-hautenormandie.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 6, 2022
• First Posted: May 13, 2022
• Study Start: November 22, 2022
• Primary Completion: November 23, 2024
• Study Completion: November 23, 2024
• Last Updated: November 23, 2022

Record last verified: 2022-11

Locations

FR (1)