NCT04564664

High-flow Oxygen Therapy During Exercise in Idiopathic Pulmonary Fibrosis

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Parc de Salut Mar · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Idiopathic Pulmonary Fibrosis

Interventions

Type	Name	Description
DRUG	Oxygen	High-flow nasal cannula oxygen therapy vs. standard oxygen therapy

Timeline

• Start date: 2019-03-01
• Primary completion: 2020-12-30
• Completion: 2021-03-30
• First posted: 2020-09-25
• Last updated: 2021-08-13

Locations

1 site across 1 country: Spain