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

NCT ID: NCT05372926

Last Updated: 2022-11-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-22

Study Completion Date

2024-11-23

Brief Summary

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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

Detailed Description

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Conditions

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Interstitial Lung Disease Pulmonary Rehabilitation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Ventury mask

Intervention Type 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.

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.

Group Type EXPERIMENTAL

high flow nasal canulae

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ADIR Association

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elise ARTAUD-MACARI, MD

Role: PRINCIPAL_INVESTIGATOR

ADIR Association

Locations

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ADIR association

Bois-Guillaume, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Elise ARTAUD-MACARI, MD

Role: CONTACT

+3332 88 59 92

Maryline LEFORT

Role: CONTACT

+3332 88 59 92

Facility Contacts

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Elise ARTAUD-MACARI, MD

Role: primary

+3332 88 59 92

Other Identifiers

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HighFlowMusc

Identifier Type: -

Identifier Source: org_study_id

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