Database of Patients Treated With Respiratory Support (observatory)
This study is currently recruiting participants.
Verified April 2012 by Association Nationale pour le Traitement à Domicile de l'Insuffisance Respiratoire
Sponsor:
Association Nationale pour le Traitement à Domicile de l'Insuffisance Respiratoire
Information provided by (Responsible Party):
Daniel VEALE, Association Nationale pour le Traitement à Domicile de l'Insuffisance Respiratoire
ClinicalTrials.gov Identifier:
NCT01181869
First received: August 11, 2010
Last updated: April 12, 2012
Last verified: April 2012
| Tracking Information | |||||||||
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| First Received Date ICMJE | August 11, 2010 | ||||||||
| Last Updated Date | April 12, 2012 | ||||||||
| Start Date ICMJE | January 1983 | ||||||||
| Estimated Primary Completion Date | January 2015 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
death [ Time Frame: 20 years ] [ Designated as safety issue: No ] long term follow up of a regularly updated database |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01181869 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
treatment adjustment [ Time Frame: 20 years ] [ Designated as safety issue: No ] Change of treatment from oxygen to ventilatioion or other evolution |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Database of Patients Treated With Respiratory Support | ||||||||
| Official Title ICMJE | Observatoire de l'ANTADIR - Database of Patients Registered as Treated With Respiratory Support in a Multicenter Homecare Federation for Patients Wirh Respiratory Problems | ||||||||
| Brief Summary | 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. |
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| 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 |
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Patients requiring respiratory support, in the ANTADIR homecare federation |
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| Condition ICMJE | Chronic Respiratory Failure | ||||||||
| Intervention ICMJE | Device: oxygen
oxygen therapy, ventilation for respiratory failure CPAP for sleep apnoea
Other Names:
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| Study Group/Cohort (s) |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 120000 | ||||||||
| Estimated Completion Date | January 2015 | ||||||||
| Estimated Primary Completion Date | January 2015 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
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| Gender | Both | ||||||||
| Ages | Not Provided | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | France | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01181869 | ||||||||
| Other Study ID Numbers ICMJE | observatoire antadir, 1983 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Daniel VEALE, Association Nationale pour le Traitement à Domicile de l'Insuffisance Respiratoire | ||||||||
| Study Sponsor ICMJE | Association Nationale pour le Traitement à Domicile de l'Insuffisance Respiratoire | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Association Nationale pour le Traitement à Domicile de l'Insuffisance Respiratoire | ||||||||
| Verification Date | April 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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