Long-term Oxygen Treatment (LTOT) in Chronic Obstructive Pulmonary Disease: Factors Influencing Survival

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

750 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-06-30

Study Completion Date

2016-05-31

Brief Summary

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The purpose of this prospective cohort study is to determine factors involved in survival in new COPD patients treated by long-term oxygen therapy.

Background: long-term oxygen therapy is indicated in patients with severe COPD. No studies have been performed in the past 20-25 years to examine the results of early clinical trials. Further studies are necessary to understand the utility of oxygen therapy in severe COPD.

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Detailed Description

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long-term oxygen therapy prolongs life in patients with severe COPD and severe resting hypoxemia. The objective of this study is to measure the survival in relation to the level of initial resting hypoxemia, serious co-morbidities, and nutritional status in COPD patients treated by long-term oxygen therapy. After enrollment at the beginning of oxygen therapy, following data will be collected during 3 years. Lung function, blood gas analysis, exercise capacity measured by the 6-Min Walk Distance test (6-MWD), dyspnea scale, BODE index, quality of life, indirect and direct costs will be analyzed every year.

Conditions

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Chronic Obstructive Pulmonary Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

COPD patients on necessity of long-term oxygen therapy

OXYGEN SUPPLEMENTATION

Intervention Type OTHER

Patients treated by LTOT, with or without clinically fulfilled criteria for LTOT, with PaO2\<55mmHg or less at rest or during sleeping or less during exercise, if supplemental oxygen is demonstrated to improve the exercise-associated hypoxia. Patients with PaO2 56-59mmHg if they also have dependent edema, pulmonary hypertension or hematocrit higher than 56%

Interventions

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OXYGEN SUPPLEMENTATION

Patients treated by LTOT, with or without clinically fulfilled criteria for LTOT, with PaO2\<55mmHg or less at rest or during sleeping or less during exercise, if supplemental oxygen is demonstrated to improve the exercise-associated hypoxia. Patients with PaO2 56-59mmHg if they also have dependent edema, pulmonary hypertension or hematocrit higher than 56%

Intervention Type OTHER

Other Intervention Names

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Patients with LTOT: survival

Eligibility Criteria

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Inclusion Criteria

* COPD patients on necessity of long-term oxygen therapy
* Patients treated by LTOT, with or without clinically fulfilled criteria for LTOT, with PaO2\<55mmHg or less at rest or during sleeping or less during exercise, if supplemental oxygen is demonstrated to improve the exercise-associated hypoxia. Patients with PaO2 56-59mmHg if they also have dependent edema, pulmonary hypertension or hematocrit higher than 56%
* Patient clinically stable
* Patient with oxygen device of ANTADIR network
* Oral and written consent

Exclusion Criteria

* Patient with obstructive sleep apnea or overlap syndrome
* Patient with non invasive ventilation
* Patient with evolutive cancer.
* Inability to complete questionnaires
* Inability to attend outpatient clinic

Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No