NCT00875719

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Feb 2009

Typical duration for not_applicable chronic-obstructive-pulmonary-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 27, 2009

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 3, 2009

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

February 16, 2011

Status Verified

February 1, 2011

Enrollment Period

1.9 years

First QC Date

March 27, 2009

Last Update Submit

February 15, 2011

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD patients with respiratory failure

Outcome Measures

Primary Outcomes (1)

  • Oxygen Saturation

    One day

Secondary Outcomes (1)

  • Walking Distance

    One day

Study Arms (1)

continuous v intermittent Oxygen therapy

ACTIVE COMPARATOR

intermittent oxygen compared to constant flow oxygen as regards walking distance

Device: Oxygen concentrators versus constant flow axygenDevice: oxygen concentrator

Interventions

Oxygen concentrators versus constant flow axygenDEVICE

Each patient performed 2 walking tests, and received oxygen supplementation from a portable concentrator or a liquid oxygen source, in a random order.

Also known as: portable oxygen concentrator
continuous v intermittent Oxygen therapy
oxygen concentratorDEVICE

comparison walk distance and saturation with continuous oxygen compared to intermittent oxygen

Also known as: portable concentrator
continuous v intermittent Oxygen therapy

Eligibility Criteria

Age45 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Evolutive heart disease.
  • Unability to understand or realize the tests.
  • Acute exacerbation during the last month.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Pneumologie et Allergologie- Hôpital le Cluzeau. 23 av. D. Larrey

Limoges, 87042, France

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Boris MELLONI, Pr

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 27, 2009

First Posted

April 3, 2009

Study Start

February 1, 2009

Primary Completion

January 1, 2011

Study Completion

February 1, 2011

Last Updated

February 16, 2011

Record last verified: 2011-02

Locations

FR(1)