High-flow Oxygen Therapy During Exercise in Idiopathic Pulmonary Fibrosis

Sponsor

Parc de Salut Mar (Other)

Overall Status

Completed

CT.gov ID

NCT04564664

Collaborator

Hospitales Universitarios Virgen del Rocío (Other)

Enrollment

Location

Arms

Actual Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Objectives:

To evaluate endurance time during cardiopulmonary exercise test (CPET) performance comparing standard oxygen therapy to high-flow nasal cannula (HFNC) oxygen therapy in subjects with idiopathic pulmonary fibrosis (IPF) with exertional desaturation.
To assess oxygenation level (peripheral and muscular) as well as dyspnea and fatigue during exercise in IPF subjects with exertional desaturation using oxygen supplementation with HFNC compared with standard oxygen supplementation.

Method: multicenter crossover clinical trial. Patients with IPF presenting oxygen desaturation during the six-minute walking test (6MWT) (SpO2 mean ≤ 85%) will be included consecutively . Each subject evaluated will perform initially an incremental CPET to evaluate the patient's maximum exercise capacity. Supplemental oxygen will be applied to maintain SpO2

85% with a Venturi mask. Maximum exercise capacity and the appropriate final oxygen inspiratory fraction (FiO2) needed for the following tests will be determined.

Posteriorly each patient will perform two constant load CPET (at 75% of the maximum workload achieved with the incremental CPET); one with standard oxygen therapy and the other one with HFNC oxygen therapy. Endurance time, dyspnea and leg fatigue and oxygen saturation (peripheral and muscular) will be recorded.

Evaluation measures: Endurance time, dyspnea and leg fatigue (Borg scale), and oxygen saturation.

Condition or Disease	Intervention/Treatment	Phase
Idiopathic Pulmonary Fibrosis	Drug: Oxygen	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

10 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

High-flow Oxygen Therapy During Exercise in Idiopathic Pulmonary Fibrosis: a Crossover Clinical Trial

Actual Study Start Date :

Mar 1, 2019

Actual Primary Completion Date :

Dec 30, 2020

Actual Study Completion Date :

Mar 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Other: High-flow nasal cannula oxygen therapy	Drug: Oxygen High-flow nasal cannula oxygen therapy vs. standard oxygen therapy
Other: Standard oxygen therapy	Drug: Oxygen High-flow nasal cannula oxygen therapy vs. standard oxygen therapy

Arm

Intervention/Treatment

Other: High-flow nasal cannula oxygen therapy

Drug: Oxygen

High-flow nasal cannula oxygen therapy vs. standard oxygen therapy

Other: Standard oxygen therapy

Drug: Oxygen

High-flow nasal cannula oxygen therapy vs. standard oxygen therapy

Outcome Measures

Primary Outcome Measures

Endurance time [through study completion, an average of 1 week]
Endurance time (s) during the constant load CPET performance with standard oxygen therapy compared to HFNC oxygen therapy

Secondary Outcome Measures

Dyspnea and fatigue [through study completion, an average of 1 week]
Dyspnea and fatigue (Borg scale) at the end of the constant load CPET with standard oxygen therapy compared to HFNC oxygen therapy
Oxygen saturation [through study completion, an average of 1 week]
Peripheral oxygen saturation (SpO2) during the constant load CPET with standard oxygen therapy compared to HFNC oxygen therapy
Muscle oxygen saturation (StO2) [through study completion, an average of 1 week]
Muscle oxygen saturation (StO2) during the constant load CPET with standard oxygen therapy compared to HFNC oxygen therapy

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Subjects with IPF diagnosis according to the 2018 international consensus guidelines
Mean SpO2 ≤ 85% during the 6MWT performed under room air conditions

Exclusion Criteria:

Fibrotic interstitial lung diseases other than IPF
Chronic obstructive pulmonary disease (COPD)
Inability to perform a complete CPET due to osteo-articular or cognitive limitations
End-stage lung disease
Severe pulmonary hypertension

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital del Mar	Barcelona		Spain	08003

Sponsors and Collaborators

Parc de Salut Mar
Hospitales Universitarios Virgen del Rocío

Investigators

Principal Investigator: Eva Balcells Vilarnau, Hospital del Mar
Study Director: Diego Agustín Rodriguez Chiariadia, Hospital del Mar

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Parc de Salut Mar

ClinicalTrials.gov Identifier:

NCT04564664

Other Study ID Numbers:

2017/7397/I

First Posted:

Sep 25, 2020

Last Update Posted:

Aug 13, 2021

Last Verified:

Sep 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Parc de Salut Mar

exertional desaturation

high-flow nasal cannula

Additional relevant MeSH terms:

Pulmonary Fibrosis

Idiopathic Pulmonary Fibrosis

Fibrosis

Study Results

No Results Posted as of Aug 13, 2021