High-flow Oxygen Therapy During Exercise in Idiopathic Pulmonary Fibrosis
Primary Purpose
Idiopathic Pulmonary Fibrosis
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Oxygen
Sponsored by
About this trial
This is an interventional treatment trial for Idiopathic Pulmonary Fibrosis focused on measuring exertional desaturation, high-flow nasal cannula
Eligibility 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
Sites / Locations
- Hospital del Mar
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
High-flow nasal cannula oxygen therapy
Standard oxygen therapy
Arm Description
Outcomes
Primary Outcome Measures
Endurance time
Endurance time (s) during the constant load CPET performance with standard oxygen therapy compared to HFNC oxygen therapy
Secondary Outcome Measures
Dyspnea and fatigue
Dyspnea and fatigue (Borg scale) at the end of the constant load CPET with standard oxygen therapy compared to HFNC oxygen therapy
Oxygen saturation
Peripheral oxygen saturation (SpO2) during the constant load CPET with standard oxygen therapy compared to HFNC oxygen therapy
Muscle oxygen saturation (StO2)
Muscle oxygen saturation (StO2) during the constant load CPET with standard oxygen therapy compared to HFNC oxygen therapy
Full Information
NCT ID
NCT04564664
First Posted
September 14, 2020
Last Updated
August 7, 2021
Sponsor
Parc de Salut Mar
Collaborators
Hospitales Universitarios Virgen del Rocío
1. Study Identification
Unique Protocol Identification Number
NCT04564664
Brief Title
High-flow Oxygen Therapy During Exercise in Idiopathic Pulmonary Fibrosis
Official Title
High-flow Oxygen Therapy During Exercise in Idiopathic Pulmonary Fibrosis: a Crossover Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
December 30, 2020 (Actual)
Study Completion Date
March 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Parc de Salut Mar
Collaborators
Hospitales Universitarios Virgen del Rocío
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Pulmonary Fibrosis
Keywords
exertional desaturation, high-flow nasal cannula
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High-flow nasal cannula oxygen therapy
Arm Type
Other
Arm Title
Standard oxygen therapy
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
Oxygen
Intervention Description
High-flow nasal cannula oxygen therapy vs. standard oxygen therapy
Primary Outcome Measure Information:
Title
Endurance time
Description
Endurance time (s) during the constant load CPET performance with standard oxygen therapy compared to HFNC oxygen therapy
Time Frame
through study completion, an average of 1 week
Secondary Outcome Measure Information:
Title
Dyspnea and fatigue
Description
Dyspnea and fatigue (Borg scale) at the end of the constant load CPET with standard oxygen therapy compared to HFNC oxygen therapy
Time Frame
through study completion, an average of 1 week
Title
Oxygen saturation
Description
Peripheral oxygen saturation (SpO2) during the constant load CPET with standard oxygen therapy compared to HFNC oxygen therapy
Time Frame
through study completion, an average of 1 week
Title
Muscle oxygen saturation (StO2)
Description
Muscle oxygen saturation (StO2) during the constant load CPET with standard oxygen therapy compared to HFNC oxygen therapy
Time Frame
through study completion, an average of 1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eva Balcells Vilarnau
Organizational Affiliation
Hospital del Mar
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Diego Agustín Rodriguez Chiariadia
Organizational Affiliation
Hospital del Mar
Official's Role
Study Director
Facility Information:
Facility Name
Hospital del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
High-flow Oxygen Therapy During Exercise in Idiopathic Pulmonary Fibrosis
We'll reach out to this number within 24 hrs