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High-flow Oxygen Therapy During Exercise in Idiopathic Pulmonary Fibrosis

NCT04564664 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2021-08-13

No results posted yet for this study

Summary

Objectives:

1. 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.
2. 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.

Conditions

Interventions

DRUG

Oxygen

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

Sponsors & Collaborators

  • Hospitales Universitarios Virgen del Rocío

    collaborator OTHER

  • Parc de Salut Mar

    lead OTHER

Principal Investigators

  • Eva Balcells Vilarnau · Hospital del Mar

  • Diego Agustín Rodriguez Chiariadia · Hospital del Mar

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-01
Primary Completion
2020-12-30
Completion
2021-03-30

Countries

  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04564664 on ClinicalTrials.gov