Idiopathic Pulmonary Fibrosis
Conditions
Keywords
exertional desaturation, high-flow nasal cannula
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.
Interventions
DRUGOxygen
High-flow nasal cannula oxygen therapy vs. standard oxygen therapy
Sponsors
Hospitales Universitarios Virgen del Rocío
Parc de Salut Mar
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Spain
Outcome results
None listed