Oxygen Portable Concentrator During Exercises in Patients With COPD

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

Comparing Effectiveness of Oxygen Supplementation From a Portable Concentrator and a Liquid Oxygen Source During Walking Test in COPD Patients With Respiratory Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00875719
• Other study ID #: ANTADIR CMTS OXYGEN 2009
• Status: Completed
• Phase: N/A
• First received: March 27, 2009
• Last updated: February 15, 2011
• Start date: February 2009
• Est. completion date: February 2011

Study information

• Verified date: February 2011
• Source: Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare differences in oxygen delivery between portable oxygen concentrators (POCs) and liquid oxygen (LOs) portable units, pose a question if POCs are equally effective as LOs in reducing exercise-induced hypoxaemia. DESIGN: Randomized, single-blind clinical trial.

Description:

Our primary objective is to compare at rest and during exercise the evolution of oxygen saturation and dyspnea during 6 minutes walking test in patients with COPD receiving oxygen supplementation either with portable concentrators or liquid oxygen in a random order.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: February 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 80 Years

Eligibility

Inclusion Criteria:

• COPD with respiratory failure and indication for oxygen supplementation at rest and/or during exercice.

Exclusion Criteria:

• Evolutive heart disease.

• Unability to understand or realize the tests.

• Acute exacerbation during the last month.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Device:
• Oxygen concentrators versus constant flow axygen
Each patient performed 2 walking tests, and received oxygen supplementation from a portable concentrator or a liquid oxygen source, in a random order.
• oxygen concentrator
comparison walk distance and saturation with continuous oxygen compared to intermittent oxygen

Locations

Country	Name	City	State
France	Service de Pneumologie et Allergologie- Hôpital le Cluzeau. 23 av. D. Larrey	LIMOGES cedex

Sponsors (1)

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

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oxygen Saturation		One day	Yes
Secondary	Walking Distance		One day	Yes