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

November 22, 2022 updated by: ADIR Association

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Bois-Guillaume, France, 76230
        • Recruiting
        • ADIR Association
        • Contact:
        • Sub-Investigator:
          • Clémence ROUSSEL
        • Sub-Investigator:
          • Catherine VIACROZE, MD
        • Sub-Investigator:
          • David DEBEAUMONT, MD
        • Sub-Investigator:
          • Tristan BONNEVIE, PHD
        • Sub-Investigator:
          • Francis-Edouard Gravier, PhD
        • Sub-Investigator:
          • Christophe GIRAULT, MD
        • Sub-Investigator:
          • Antoine CUVELIER, MD, PHD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ptdi swing
Time Frame: 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.
during the intervention, at isotime

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PTPdi
Time Frame: during the intervention, at isotime
on effort at isotime, comparison between HFNC and VM of diaphragmatic pressure time product during a respiratory cycle (PTPdi)
during the intervention, at isotime
PTPoeso
Time Frame: 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)
during the intervention, at isotime
Poeso swing
Time Frame: 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)
during the intervention, at isotime
DeltaPtdi/DeltaEAdi
Time Frame: 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)
during the intervention, at isotime
SmO2
Time Frame: 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)
during the intervention, at isotime
TcCO2
Time Frame: during the intervention, at isotime
on effort at isotime, comparison between HFNC and VM of transcutaneous CO2 measurement (TcCO2)
during the intervention, at isotime
Tlim
Time Frame: during the intervention, at the end of endurance test
Comparison of endurance time (Tlim) between HFNC and VM
during the intervention, at the end of endurance test

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ADIR Association

Investigators

  • Principal Investigator: Elise ARTAUD-MACARI, MD, ADIR Association

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 22, 2022

Primary Completion (Anticipated)

November 23, 2024

Study Completion (Anticipated)

November 23, 2024

Study Registration Dates

First Submitted

April 6, 2022

First Submitted That Met QC Criteria

May 9, 2022

First Posted (Actual)

May 13, 2022

Study Record Updates

Last Update Posted (Actual)

November 23, 2022

Last Update Submitted That Met QC Criteria

November 22, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HighFlowMusc

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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