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

Not Applicable

Recruiting

• Conditions: Interstitial Lung Disease; Pulmonary Rehabilitation
• Interventions: Device: Ventury mask; Device: high flow nasal canulae

• Registration Number: NCT05372926
• Lead Sponsor: ADIR Association

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-04-06
• Study First Submitted QC: 2022-05-09
• Study First Posted: 2022-05-13
• Status Verified: 2022-11
• Study Start: 2022-11-22
• Last Update Submitted: 2022-11-22
• Last Update Posted: 2022-11-23
• Primary Completion: 2024-11-23
• Study Completion: 2024-11-23

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Venturi mask	Ventury 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.
High flow nasal canulae	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)
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)
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)
Tlim	during the intervention, at the end of endurance test	Comparison of endurance time (Tlim) between HFNC and VM
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)
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)

Trial Locations

Locations (1)

ADIR association; 🇫🇷 Bois-Guillaume, France