Clinical trial NCT04564664: High-flow Oxygen Therapy During Exercise in Idiopathic Pulmonary Fibrosis
Official title: High-flow Oxygen Therapy During Exercise in Idiopathic Pulmonary Fibrosis: a Crossover Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Idiopathic Pulmonary Fibrosis
Keywords: exertional desaturation
high-flow nasal cannula
Lead sponsor: Parc de Salut Mar
Sponsor class: OTHER
Collaborators: name: Hospitales Universitarios Virgen del Rocío
First posted: 2020-09-25
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Endurance time
timeFrame: through study completion, an average of 1 week
Secondary outcomes:
measure: Dyspnea and fatigue
timeFrame: through study completion, an average of 1 week
measure: Oxygen saturation
timeFrame: through study completion, an average of 1 week
measure: Muscle oxygen saturation (StO2)
timeFrame: through study completion, an average of 1 week
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital del Mar
Study officials:
affiliation: Hospital del Mar
name: Eva Balcells Vilarnau
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital del Mar
name: Diego Agustín Rodriguez Chiariadia
role: STUDY_DIRECTOR
References: