High-flow Oxygen Therapy During Exercise in Idiopathic Pulmonary Fibrosis

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

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.

Study Overview

• Status: Completed
• Conditions: Idiopathic Pulmonary Fibrosis
• Intervention / Treatment: Drug: Oxygen

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08003
    • Hospital Del Mar

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: High-flow nasal cannula oxygen therapy	Drug: Oxygen; High-flow nasal cannula oxygen therapy vs. standard oxygen therapy
Other: Standard oxygen therapy	Drug: Oxygen; High-flow nasal cannula oxygen therapy vs. standard oxygen therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Endurance time	Endurance time (s) during the constant load CPET performance with standard oxygen therapy compared to HFNC oxygen therapy	through study completion, an average of 1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	through study completion, an average of 1 week
Oxygen saturation	Peripheral oxygen saturation (SpO2) during the constant load CPET with standard oxygen therapy compared to HFNC oxygen therapy	through study completion, an average of 1 week
Muscle oxygen saturation (StO2)	Muscle oxygen saturation (StO2) during the constant load CPET with standard oxygen therapy compared to HFNC oxygen therapy	through study completion, an average of 1 week

Collaborators and Investigators

• Sponsor: Parc de Salut Mar
• Collaborators: Hospitales Universitarios Virgen del Rocío
• Investigators: Principal Investigator: Eva Balcells Vilarnau, Hospital Del Mar; Study Director: Diego Agustín Rodriguez Chiariadia, Hospital Del Mar

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Actual): December 30, 2020
• Study Completion (Actual): March 30, 2021

Study Registration Dates

• First Submitted: September 14, 2020
• First Submitted That Met QC Criteria: September 21, 2020
• First Posted (Actual): September 25, 2020

Study Record Updates

• Last Update Posted (Actual): August 13, 2021
• Last Update Submitted That Met QC Criteria: August 7, 2021
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: high-flow nasal cannula; exertional desaturation
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Fibrosis; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis
• Other Study ID Numbers: 2017/7397/I

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No