Can High-Flow Oxygen Therapy Improve Oxygenation During Exercise in ILD Patients?

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Status: Unknown

Conditions: Intersticial Lung Disease

Treatments: Drug: oxygen therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03287713

IIBSP-OXI-2017-18

Details and patient eligibility

About

Objectives: 1.- To compare the level of oxygenation achieved during muscular training with conventional oxygen systems (nasal cannulas) versus nasal High-flow oxygen therapy. 2.-To compare benefits achieved with both systems, in terms of: level of exercise during training; effort tolerance in the 6 minutes walking test (6MWT); improvement of dyspnoea and Health-related quality of life (HRQoL). And analyse the effects of nasal High-flow oxygen therapy on the acute exercise in a subgroup of patients.

Method: Multicentric randomized clinical trial. Patients with ILD in fibrotic phase who present oxygen desaturation during 6MWT (SpO2 mean ≤ 85%) will be included consecutively. Will be randomized in two groups: ILD patients with conventional oxygen (EPIDOC) and ILD patients with nasal High-Flow oxygen therapy (EPIDOAF). Both groups will perform a Pulmonary Rehabilitation Program. Oxygen will be titrated respectively to flow and FiO2 needed to maintain SpO2 ≥ 90% during training with both systems. Evaluation measures: SpO2 during training in both groups; dyspnoea (mMRC scale and CRQ dyspnoea); exercise capacity (6MWT) and HRQoL (self- administered KBILD questionnaire and SF36). In a subgroup of patients will be compared time of endurance exercise to evaluate the effects of nasal high-flow oxygen therapy in the acute exercise.

Enrollment: 60 estimated patients

Sex: All

Ages: 30 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age > 30 years old
• Diagnostic of ILD according to the national and international guidelines 23
• Being clinically stable the previous 4 weeks
• Acceptance to participate in the trial

Exclusion criteria

• Have been enrolled in a PR program in the last previous 6 months
• Respiratory Diseases other than ILD or severe comorbidities
• Osteoarticular diseases which don't allow training
• End-stage ILD, treatment with opiates or survival < 6 months
• Cognitive alterations that preclude colaboration

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Conventional oxygen (EPIDOC)

Active Comparator group

Description:

Patients randomized in conventional oxygen (EPIDOC) group will perform a Pulmonary Rehabilitation Program. Oxygen will be titrated to flow needed to maintain SpO2 ≥ 90% during training with both systems.

Treatment:

Drug: oxygen therapy

Nasal High-Flow oxygen therapy (EPIDOAF)

Active Comparator group

Description:

Patients will be randomized in nasal High-Flow oxygen therapy (EPIDOAF) group will perform a Pulmonary Rehabilitation Program. Oxygen will be titrated to FiO2 needed to maintain SpO2 ≥ 90% during training with both systems.

Treatment:

Drug: oxygen therapy