Efficacy of Oxygen Therapy Delivered by Systems Using Oxygen-Saving Valves in COPD Patients

Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche

Status: Enrolling

Conditions: LUNG DISEASES, OBSTRUCTIVE

Treatments: Device: continuous oxygen; Device: pulse oxygen supplementation devices

Study type: Interventional

Funder types: Other

Identifiers

NCT01180803

EVAL- CLIN A00690-39

Details and patient eligibility

About

The purpose of this study is to compare the efficacy of oxygen therapy delivered by systems using oxygen-saving valves or not (continuous oxygen). We aim to determine if systems using oxygen-saving valves are equally effective as continuous oxygen delivery systems in reducing exercise-induced hypoxemia in patients with COPD.

Enrollment: 200 estimated patients

Sex: All

Ages: 45 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• COPD on necessity of long term oxygen therapy
• Able to give their written consent

Exclusion criteria

• Unstable patients with COPD
• Patients with restrictive respiratory disease
• Patients with cardiac or neurologic disease contre-indicating the different evaluations

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

oxygen-saving valves

Experimental group

Treatment:

Device: pulse oxygen supplementation devices

continuous oxygen supplementation

Active Comparator group

Treatment:

Device: continuous oxygen