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Database of Patients Treated With Respiratory Support (observatory)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2012 by Daniel VEALE, Association Nationale pour le Traitement à Domicile de l'Insuffisance Respiratoire.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01181869
First Posted: August 13, 2010
Last Update Posted: April 13, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Daniel VEALE, Association Nationale pour le Traitement à Domicile de l'Insuffisance Respiratoire
  Purpose
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.

Condition Intervention
Chronic Respiratory Failure Device: oxygen

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Observatoire de l'ANTADIR - Database of Patients Registered as Treated With Respiratory Support in a Multicenter Homecare Federation for Patients Wirh Respiratory Problems

Resource links provided by NLM:


Further study details as provided by Daniel VEALE, Association Nationale pour le Traitement à Domicile de l'Insuffisance Respiratoire:

Primary Outcome Measures:
  • death [ Time Frame: 20 years ]
    long term follow up of a regularly updated database


Secondary Outcome Measures:
  • treatment adjustment [ Time Frame: 20 years ]
    Change of treatment from oxygen to ventilatioion or other evolution


Estimated Enrollment: 120000
Study Start Date: January 1983
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Oxygen therapy
Database of patients on oxygen
Device: oxygen
oxygen therapy, ventilation for respiratory failure CPAP for sleep apnoea
Other Names:
  • LTOT
  • NIV
  • CPAP
ventilation
database of patients on ventilatory support
Device: oxygen
oxygen therapy, ventilation for respiratory failure CPAP for sleep apnoea
Other Names:
  • LTOT
  • NIV
  • CPAP
Continuous positive airway pressure
Sleep apnoea patients on CPAP
Device: oxygen
oxygen therapy, ventilation for respiratory failure CPAP for sleep apnoea
Other Names:
  • LTOT
  • NIV
  • CPAP

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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients requiring respiratory support, in the ANTADIR homecare federation
Criteria

Inclusion Criteria:

  • requiring respiratory support
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01181869


Contacts
Contact: Line Mounier, MSc 0033156814060 antadir@antadir.com
Contact: Dan Veale, MD 0033156814060 veale.dan@gmail.com

Locations
France
ANTADIR Recruiting
Paris, France, 75006
Sponsors and Collaborators
Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche
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
  More Information

Additional Information:
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. 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.
Chailleux E, Boffa C. [Chronic respiratory insufficiency in France]. Rev Prat. 2001 May 31;51(10):1061-5. Review. 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.
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.
Voisin C. [Medico-social management of severe respiratory insufficiency. Role of Associations]. Bull Acad Natl Med. 1998;182(6):1159-71; discussion 1172. Review. 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.

Responsible Party: Daniel VEALE, Investigator, Association Nationale pour le Traitement à Domicile de l'Insuffisance Respiratoire
ClinicalTrials.gov Identifier: NCT01181869     History of Changes
Other Study ID Numbers: observatoire antadir
1983 ( Other Identifier: antadir )
First Submitted: August 11, 2010
First Posted: August 13, 2010
Last Update Posted: April 13, 2012
Last Verified: April 2012

Keywords provided by Daniel VEALE, Association Nationale pour le Traitement à Domicile de l'Insuffisance Respiratoire:
respiratory failure
oxygen
sleep apnoea
ventilation

Additional relevant MeSH terms:
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases


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