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

Primary Purpose

Interstitial Lung Disease, Pulmonary Rehabilitation

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
high flow nasal canulae
Ventury mask
Sponsored by
ADIR Association
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Interstitial Lung Disease focused on measuring interstitial lung disease, nasal high flow oxygen therapy, endurance test, pulmonary rehabilitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • ADIR associationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Venturi mask

High flow nasal canulae

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

PTPdi
on effort at isotime, comparison between HFNC and VM of diaphragmatic pressure time product during a respiratory cycle (PTPdi)
PTPoeso
on effort at isotime, comparison between HFNC and VM of the respiratory "Pressure Time Product" during a respiratory cycle (PTPoeso)
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)
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)
SmO2
on effort at isotime, comparison between HFNC and VM of the measurement of tissue saturation in oxygen (SmO2) by "Near Infrared Spectrometry" (NIRS)
TcCO2
on effort at isotime, comparison between HFNC and VM of transcutaneous CO2 measurement (TcCO2)
Tlim
Comparison of endurance time (Tlim) between HFNC and VM

Full Information

First Posted
April 6, 2022
Last Updated
November 22, 2022
Sponsor
ADIR Association
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1. Study Identification

Unique Protocol Identification Number
NCT05372926
Brief Title
Physiological Effects of HFNC During Exercise in Patients With Fibrosing Interstitial Lung Diseases
Acronym
HighFlowMusc
Official Title
Evaluation of the Physiological Effects of High Flow Nasal Canulae Oxygen Therapy During Exercise in Patients With Fibrosing Interstitial Lung Diseases
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 22, 2022 (Actual)
Primary Completion Date
November 23, 2024 (Anticipated)
Study Completion Date
November 23, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ADIR Association

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Interstitial Lung Disease, Pulmonary Rehabilitation
Keywords
interstitial lung disease, nasal high flow oxygen therapy, endurance test, pulmonary rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Venturi mask
Arm Type
Experimental
Arm Description
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.
Arm Title
High flow nasal canulae
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
high flow nasal canulae
Intervention Description
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
Intervention Name(s)
Ventury mask
Intervention Description
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.
Primary Outcome Measure Information:
Title
Ptdi swing
Description
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.
Time Frame
during the intervention, at isotime
Secondary Outcome Measure Information:
Title
PTPdi
Description
on effort at isotime, comparison between HFNC and VM of diaphragmatic pressure time product during a respiratory cycle (PTPdi)
Time Frame
during the intervention, at isotime
Title
PTPoeso
Description
on effort at isotime, comparison between HFNC and VM of the respiratory "Pressure Time Product" during a respiratory cycle (PTPoeso)
Time Frame
during the intervention, at isotime
Title
Poeso swing
Description
on effort at isotime, comparison between HFNC and VM of variation of oesophagal pressure between the base state and the peak (Poeso swing)
Time Frame
during the intervention, at isotime
Title
DeltaPtdi/DeltaEAdi
Description
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)
Time Frame
during the intervention, at isotime
Title
SmO2
Description
on effort at isotime, comparison between HFNC and VM of the measurement of tissue saturation in oxygen (SmO2) by "Near Infrared Spectrometry" (NIRS)
Time Frame
during the intervention, at isotime
Title
TcCO2
Description
on effort at isotime, comparison between HFNC and VM of transcutaneous CO2 measurement (TcCO2)
Time Frame
during the intervention, at isotime
Title
Tlim
Description
Comparison of endurance time (Tlim) between HFNC and VM
Time Frame
during the intervention, at the end of endurance test

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elise ARTAUD-MACARI, MD
Phone
+3332 88 59 92
Email
eliseartaudmacari@yahoo.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Maryline LEFORT
Phone
+3332 88 59 92
Email
mlefort@adir-hautenormandie.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elise ARTAUD-MACARI, MD
Organizational Affiliation
ADIR Association
Official's Role
Principal Investigator
Facility Information:
Facility Name
ADIR association
City
Bois-Guillaume
ZIP/Postal Code
76230
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elise ARTAUD-MACARI, MD
Phone
+3332 88 59 92
Email
eliseartaudmacari@yahoo.fr
First Name & Middle Initial & Last Name & Degree
Clémence ROUSSEL
First Name & Middle Initial & Last Name & Degree
Catherine VIACROZE, MD
First Name & Middle Initial & Last Name & Degree
David DEBEAUMONT, MD
First Name & Middle Initial & Last Name & Degree
Tristan BONNEVIE, PHD
First Name & Middle Initial & Last Name & Degree
Francis-Edouard GRAVIER, PHD
First Name & Middle Initial & Last Name & Degree
Christophe GIRAULT, MD
First Name & Middle Initial & Last Name & Degree
Antoine CUVELIER, MD, PHD

12. IPD Sharing Statement

Learn more about this trial

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

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