High-flow Oxygen Therapy During Exercise in Idiopathic Pulmonary Fibrosis
NCT ID: NCT04564664
Last Updated: 2021-08-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
10 participants
INTERVENTIONAL
2019-03-01
2021-03-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Can High-Flow Oxygen Therapy Improve Oxygenation During Exercise in ILD Patients?
NCT03287713
Effects of Automated Oxygen Titration Alone or With High Flow Nasal Therapy on Dyspnea and Exercise Tolerance
NCT05267418
Nasal High-flow Oxygen Therapy During Acute Exercise in Fibrotic Interstitial Lung Disease
NCT07129707
Short-term Effects of Supplemental Oxygen in Patients With IPF
NCT03050255
Effects of Blood Flow Restriction Aerobic Exercise on Inflammation, Hypoxia, Exercise Capacity, and Lung Function in COPD
NCT07261293
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
High-flow nasal cannula oxygen therapy
Oxygen
High-flow nasal cannula oxygen therapy vs. standard oxygen therapy
Standard oxygen therapy
Oxygen
High-flow nasal cannula oxygen therapy vs. standard oxygen therapy
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Oxygen
High-flow nasal cannula oxygen therapy vs. standard oxygen therapy
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Mean SpO2 ≤ 85% during the 6MWT performed under room air conditions
Exclusion Criteria
* 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
18 Years
85 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hospitales Universitarios Virgen del Rocío
OTHER
Parc de Salut Mar
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Eva Balcells Vilarnau
Role: PRINCIPAL_INVESTIGATOR
Hospital del Mar
Diego Agustín Rodriguez Chiariadia
Role: STUDY_DIRECTOR
Hospital del Mar
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hospital del Mar
Barcelona, , Spain
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2017/7397/I
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.