- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01181869
Database of Patients Treated With Respiratory Support (observatory)
April 12, 2012 updated by: Daniel VEALE, Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche
Observatoire de l'ANTADIR - Database of Patients Registered as Treated With Respiratory Support in a Multicenter Homecare Federation for Patients Wirh Respiratory Problems
An observatory of patients registered in 22 local homecare associations in France, for respiratory diseases, with annual data update.
Demographic and clinical data are registered rendering possible extraction of clinical and prognostic data.
Study Overview
Detailed Description
Patients on treatment for respiratory failure and for sleep apnoea are registered on entry into treatment with recording of clincal and demographic data.
Data available on age, sex, region, respiratoy function, blood gases, smoking status and some bilogical data
Study Type
Observational
Enrollment (Anticipated)
120000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Line Mounier, MSc
- Phone Number: 0033156814060
- Email: antadir@antadir.com
Study Contact Backup
- Name: Dan Veale, MD
- Phone Number: 0033156814060
- Email: veale.dan@gmail.com
Study Locations
-
-
-
Paris, France, 75006
- Recruiting
- ANTADIR
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients requiring respiratory support, in the ANTADIR homecare federation
Description
Inclusion Criteria:
- requiring respiratory support
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Oxygen therapy
Database of patients on oxygen
|
oxygen therapy, ventilation for respiratory failure CPAP for sleep apnoea
Other Names:
|
ventilation
database of patients on ventilatory support
|
oxygen therapy, ventilation for respiratory failure CPAP for sleep apnoea
Other Names:
|
Continuous positive airway pressure
Sleep apnoea patients on CPAP
|
oxygen therapy, ventilation for respiratory failure CPAP for sleep apnoea
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
death
Time Frame: 20 years
|
long term follow up of a regularly updated database
|
20 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
treatment adjustment
Time Frame: 20 years
|
Change of treatment from oxygen to ventilatioion or other evolution
|
20 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Daniel VEALE, MD, ANTADIR scientific committee
- Study Chair: Jean Francois MUIR, MD, Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Chambellan A, Chailleux E, Similowski T; ANTADIR Observatory Group. Prognostic value of the hematocrit in patients with severe COPD receiving long-term oxygen therapy. Chest. 2005 Sep;128(3):1201-8. doi: 10.1378/chest.128.3.1201. Erratum In: Chest. 2006 Mar;129(3):831.
- Chailleux E, Laaban JP, Veale D. Prognostic value of nutritional depletion in patients with COPD treated by long-term oxygen therapy: data from the ANTADIR observatory. Chest. 2003 May;123(5):1460-6. doi: 10.1378/chest.123.5.1460.
- Chailleux E, Boffa C. [Chronic respiratory insufficiency in France]. Rev Prat. 2001 May 31;51(10):1061-5. French.
- Veale D, Chailleux E, Hoorelbeke-Ramon A, Reybet-Degas O, Humeau-Chapuis MP, Alluin-Aigouy F, Fleury B, Jonquet O, Michard P. Mortality of sleep apnoea patients treated by nasal continuous positive airway pressure registered in the ANTADIR observatory. Association Nationale pour le Traitement A Domicile de l'Insuffisance Respiratoire chronique. Eur Respir J. 2000 Feb;15(2):326-31. doi: 10.1034/j.1399-3003.2000.15b18.x.
- Veale D, Chailleux E, Taytard A, Cardinaud JP. Characteristics and survival of patients prescribed long-term oxygen therapy outside prescription guidelines. Eur Respir J. 1998 Oct;12(4):780-4. doi: 10.1183/09031936.98.12040780.
- Voisin C. [Medico-social management of severe respiratory insufficiency. Role of Associations]. Bull Acad Natl Med. 1998;182(6):1159-71; discussion 1172. French.
- Chailleux E, Fauroux B, Binet F, Dautzenberg B, Polu JM. Predictors of survival in patients receiving domiciliary oxygen therapy or mechanical ventilation. A 10-year analysis of ANTADIR Observatory. Chest. 1996 Mar;109(3):741-9. doi: 10.1378/chest.109.3.741.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 1983
Primary Completion (Anticipated)
January 1, 2015
Study Completion (Anticipated)
January 1, 2015
Study Registration Dates
First Submitted
August 11, 2010
First Submitted That Met QC Criteria
August 12, 2010
First Posted (Estimate)
August 13, 2010
Study Record Updates
Last Update Posted (Estimate)
April 13, 2012
Last Update Submitted That Met QC Criteria
April 12, 2012
Last Verified
April 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- observatoire antadir
- 1983 (Other Identifier: antadir)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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