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

Sponsor

ADIR Association (Other)

Overall Status

Recruiting

CT.gov ID

NCT05372926

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Interstitial Lung Disease Pulmonary Rehabilitation	Device: high flow nasal canulae Device: Ventury mask	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

16 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

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.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.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jul 10, 2022

Anticipated Primary Completion Date :

Apr 10, 2024

Anticipated Study Completion Date :

Apr 10, 2024

Arms and Interventions

Arm	Intervention/Treatment
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.	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.
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.	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.

Arm

Intervention/Treatment

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.

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.

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.

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.

Outcome Measures

Primary Outcome Measures

Ptdi swing [during the intervention, at isotime]
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.

Secondary Outcome Measures

PTPdi [during the intervention, at isotime]
on effort at isotime, comparison between HFNC and VM of diaphragmatic pressure time product during a respiratory cycle (PTPdi)
PTPoeso [during the intervention, at isotime]
on effort at isotime, comparison between HFNC and VM of the respiratory "Pressure Time Product" during a respiratory cycle (PTPoeso)
Poeso swing [during the intervention, at isotime]
on effort at isotime, comparison between HFNC and VM of variation of oesophagal pressure between the base state and the peak (Poeso swing)
DeltaPtdi/DeltaEAdi [during the intervention, at isotime]
on 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)
SmO2 [during the intervention, at isotime]
on effort at isotime, comparison between HFNC and VM of the measurement of tissue saturation in oxygen (SmO2) by "Near Infrared Spectrometry" (NIRS)
TcCO2 [during the intervention, at isotime]
on effort at isotime, comparison between HFNC and VM of transcutaneous CO2 measurement (TcCO2)
Tlim [during the intervention, at the end of endurance test]
Comparison of endurance time (Tlim) between HFNC and VM

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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