High-flow Oxygen Therapy During Exercise in Idiopathic Pulmonary Fibrosis

Idiopathic Pulmonary Fibrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04564664
• Other study ID #: 2017/7397/I
• Status: Completed
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: March 30, 2021

Study information

• Verified date: September 2020
• Source: Parc de Salut Mar
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: March 30, 2021
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Fibrosis
• Idiopathic Pulmonary Fibrosis
• Pulmonary Fibrosis

Intervention

Drug:
• Oxygen
High-flow nasal cannula oxygen therapy vs. standard oxygen therapy

Locations

Country	Name	City	State
Spain	Hospital del Mar	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Parc de Salut Mar	Hospitales Universitarios Virgen del Rocío

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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