Observance of Long Term Oxygen Therapy in Chronic Inspiratory Disease Patients


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Verified June 2017 by SOS Oxygene Mediterranee

Sponsor:

Collaborator:

CHU Arnaud de Villeneuve MONTPELLIER

Information provided by (Responsible Party):

SOS Oxygene Mediterranee

ClinicalTrials.gov Identifier:

NCT03188588

First received: June 12, 2017

Last updated: June 13, 2017

Last verified: June 2017

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.

Chronic Respiratory Disease
Hypoxemia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observance of Long Term Oxygen Therapy in Chronic Inspiratory Disease Patients

Primary Outcome Measures:

  • oxygen use [ Time Frame: 6 month ]

    time of oxygen use

Secondary Outcome Measures:

  • respiratory disease severity based on GOLD standards [ Time Frame: baseline ]
  • quality of life assessed by a questionnaire (VQ-11) [ Time Frame: baseline, 3 month and 6 month ]
  • precarity score assessed by a questionnaire (EPICE) [ Time Frame: baseline ]

Estimated Enrollment: 120
Actual Study Start Date: January 2017
Estimated Study Completion Date: January 2019
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample

patients are recruited from pneumologia unit of hospital and from private pneumologists

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03188588

CHU Arnaud de Villeneuve
Montpellier, France, 34295
Contact: Arnaud Bourdin, professor    +33 4 67 33 61 26    arnaudbourdin@hotmail.com   

SOS Oxygene Mediterranee

CHU Arnaud de Villeneuve MONTPELLIER

Principal Investigator: Arnaud Bourdin, Professor CHU Montpellier, France

Responsible Party: SOS Oxygene Mediterranee
ClinicalTrials.gov Identifier: NCT03188588     History of Changes
Other Study ID Numbers: 2016-A01244-47
Study First Received: June 12, 2017
Last Updated: June 13, 2017
Individual Participant Data  
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Respiration Disorders
Respiratory Tract Diseases
Anoxia
Signs and Symptoms, Respiratory
Signs and Symptoms

ClinicalTrials.gov processed this record on June 15, 2017