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

Interstitial Lung Disease Clinical Trial

— HighFlowMusc  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05372926
• Other study ID #: HighFlowMusc
• Status: Recruiting
• Phase: N/A
• Start date: November 22, 2022
• Est. completion date: November 23, 2024

Study information

• Verified date: November 2022
• Source: ADIR Association
• Contact: Elise ARTAUD-MACARI, MD
• Phone: +3332 88 59 92
• Email: eliseartaudmacari[@]yahoo.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 16
• Est. completion date: November 23, 2024
• Est. primary completion date: November 23, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Interstitial Lung Disease
• Lung Diseases
• Lung Diseases, Interstitial
• Pulmonary Rehabilitation

Intervention

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.
• 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.

Locations

Country	Name	City	State
France	ADIR association	Bois-Guillaume

Sponsors (1)

Lead Sponsor	Collaborator
ADIR Association

Country where clinical trial is conducted

France, 

Outcome

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