High-flow Oxygen Therapy During Exercise in Idiopathic Pulmonary Fibrosis

Not Applicable

Completed

• Conditions: Idiopathic Pulmonary Fibrosis
• Interventions: Drug: Oxygen

• Registration Number: NCT04564664
• Lead Sponsor: Parc de Salut Mar

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-01
• Status Verified: 2020-09
• Study First Submitted: 2020-09-14
• Study First Submitted QC: 2020-09-21
• Study First Posted: 2020-09-25
• Primary Completion: 2020-12-30
• Study Completion: 2021-03-30
• Last Update Submitted: 2021-08-07
• Last Update Posted: 2021-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Subjects with IPF diagnosis according to the 2018 international consensus guidelines
• Mean SpO2 ≤ 85% during the 6MWT performed under room air conditions

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
High-flow nasal cannula oxygen therapy	Oxygen	-
Standard oxygen therapy	Oxygen	-

Primary Outcome Measures

Name	Time	Method
Endurance time	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

Name	Time	Method
Dyspnea and fatigue	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
Oxygen saturation	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
Muscle oxygen saturation (StO2)	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

Trial Locations

Locations (1)

Hospital del Mar; 🇪🇸 Barcelona, Spain