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High-flow Oxygen Therapy During Exercise in Idiopathic Pulmonary Fibrosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04564664
Recruitment Status : Completed
First Posted : September 25, 2020
Last Update Posted : August 13, 2021
Sponsor:
Collaborator:
Hospitales Universitarios Virgen del Rocío
Information provided by (Responsible Party):
Parc de Salut Mar

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Idiopathic Pulmonary Fibrosis Drug: Oxygen Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
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 : March 1, 2019
Actual Primary Completion Date : December 30, 2020
Actual Study Completion Date : March 30, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
High-flow nasal cannula oxygen therapy Drug: Oxygen
High-flow nasal cannula oxygen therapy vs. standard oxygen therapy
Standard oxygen therapy Drug: Oxygen
High-flow nasal cannula oxygen therapy vs. standard oxygen therapy


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04564664


Locations
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Spain
Hospital del Mar
Barcelona, Spain, 08003
Sponsors and Collaborators
Parc de Salut Mar
Hospitales Universitarios Virgen del Rocío
Investigators
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Principal Investigator: Eva Balcells Vilarnau Hospital del Mar
Study Director: Diego Agustín Rodriguez Chiariadia Hospital del Mar
More Information
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Responsible Party: Parc de Salut Mar
ClinicalTrials.gov Identifier: NCT04564664    
Other Study ID Numbers: 2017/7397/I
First Posted: September 25, 2020    Key Record Dates
Last Update Posted: August 13, 2021
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Parc de Salut Mar:
exertional desaturation
high-flow nasal cannula
Additional relevant MeSH terms:
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Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Fibrosis
 Pathologic Processes
Lung Diseases
Respiratory Tract Diseases