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NCT03188588 Clinical Trial

Observance of Long Term Oxygen Therapy in Chronic Inspiratory Disease Patients

Hypoxemia Clinical Trial

— ObsO2  

Official title:
Observance of Long Term Oxygen Therapy in Chronic Inspiratory Disease Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03188588
Other study ID # 2016-A01244-47
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 2017
Est. completion date January 1, 2020

Study information
Verified date June 2017
Source SOS Oxygene Mediterranee
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Long-term oxygen therapy (LTOT) is the reference treatment for chronic respiratory failure. This treatment is based on the principle of oxygen supplementation via a source to correct hypoxemia in patients. At present, adherence to this treatment is difficult to evaluate (reporting by patients), but the results of the literature show poor LTOT compliance. It is therefore important to accurately measure the oxygen consumption by patients and to understand the factors explaining LTOT compliance. The ultimate aim is to improve our patient management to make them more observant in order to improve the therapeutic efficacy of the treatment.

Recruitment information / eligibility
Status Completed
Enrollment 120
Est. completion date January 1, 2020
Est. primary completion date January 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria:

- chronic respiratory disease patients with chronic hypoxemia

- First prescribed long term oxygenotherapy

Exclusion Criteria:

- patients with NIV and CPAP

- vital pronostic < 3 months

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
France CHU Arnaud de Villeneuve Montpellier

Sponsors (2)
Lead Sponsor Collaborator
SOS Oxygene Mediterranee CHU Arnaud de Villeneuve MONTPELLIER

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary oxygen use time of oxygen use 6 month
Secondary respiratory disease severity based on GOLD standards baseline
Secondary quality of life assessed by a questionnaire (VQ-11) baseline, 3 month and 6 month
Secondary precarity score assessed by a questionnaire (EPICE) baseline
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