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Completed

NCT Number: NCT04564664

High-flow Oxygen Therapy During Exercise in Idiopathic Pulmonary Fibrosis

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.

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Key information

Conditions

Idiopathic Pulmonary Fibrosis Lung Diseases Lung Diseases, Interstitial Pulmonary Fibrosis Respiratory Tract Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital del Mar

Barcelona, 08003, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oxygen

Drug

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

Primary outcomes

  1. Endurance time

    Time frame: 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 outcomes

  1. Dyspnea and fatigue

    Time frame: 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

  2. Oxygen saturation

    Time frame: 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

  3. Muscle oxygen saturation (StO2)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Parc de Salut Mar

Other

Collaborators

  • Hospitales Universitarios Virgen del Rocío

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Sep 25, 2020
Registry last updated
Aug 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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