Chronic Respiratory FailureobservatoryNCT01181869
Database of Patients Treated With Respiratory Support
An observational study of Chronic Respiratory Failure, run by Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Respiratory Failure
- What is being tested?
- oxygen
- Type of treatment
- Medical device
- How many people
- 120,000 participants
- Where
- 1 siteFrance
- Study dates
- Jan 1983to Jan 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients requiring respiratory support, in the ANTADIR homecare federation
Who may be able to join
- requiring respiratory support
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Conditions
- Chronic Respiratory Failure
- Being tested
- oxygen
- Keywords
- respiratory failure, oxygen, sleep apnoea, ventilation
- Medical subject headings
- Respiratory Insufficiency, Sleep Apnea Syndromes, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oxygenDevice
Also called LTOT, NIV, CPAP
oxygen therapy, ventilation for respiratory failure CPAP for sleep apnoea
| Study group | Role | What they receive |
|---|---|---|
| Oxygen therapy | Database of patients on oxygen Receives: Device: oxygen | |
| ventilation | database of patients on ventilatory support Receives: Device: oxygen | |
| Continuous positive airway pressure | Sleep apnoea patients on CPAP Receives: Device: oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
death
long term follow up of a regularly updated database
Measured: 20 years
Secondary outcomes (1)
treatment adjustment
Change of treatment from oxygen to ventilatioion or other evolution
Measured: 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2010 (estimated)
- Study startJan 1983
- Primary completionJan 2015 (estimated)
- Study completionJan 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Chronic Respiratory FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 120,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel VEALE, Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche
- Investigators
- Daniel VEALE, MD, Study director, ANTADIR scientific committeeJean Francois MUIR, MD, Study chair, Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01181869
- Sponsor's protocol ID
- observatoire antadir
- Other IDs
- 1983
- Acronym
- observatory
- Status last verified
- Apr 2012
- First submitted
- 11 Aug 2010
- Last updated
- 13 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 16162707Chailleux 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.
PubMed 12740261Chailleux E, Boffa C. [Chronic respiratory insufficiency in France]. Rev Prat. 2001 May 31;51(10):1061-5. French.
PubMed 11468903Veale 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.
PubMed 10706500Veale 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.
PubMed 9817145Voisin C. [Medico-social management of severe respiratory insufficiency. Role of Associations]. Bull Acad Natl Med. 1998;182(6):1159-71; discussion 1172. French.
PubMed 9812404Chailleux 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.
PubMed 8617085
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01181869
- Acronym / sponsor ID
- observatory / observatoire antadir
- Conditions
- Chronic Respiratory Failure
- Keywords
- respiratory failure, oxygen, sleep apnoea, ventilation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120,000 participants (estimated)
- Lead sponsor
- Association Nationale pour les Traitements A Domicile, les Innovations et la RechercheUniversity, hospital or other
- Study start
- Jan 1983
- Primary completion
- Jan 2015 (estimated)
- Study completion
- Jan 2015 (estimated)
- First posted
- 13 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Oxygen therapy | – | Device: oxygenDatabase of patients on oxygen |
| ventilation | – | Device: oxygendatabase of patients on ventilatory support |
| Continuous positive airway pressure | – | Device: oxygenSleep apnoea patients on CPAP |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients requiring respiratory support, in the ANTADIR homecare federation
Key inclusion criteria (1 listed)
- requiring respiratory support
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oxygenAlso: LTOT, NIV, CPAPoxygen therapy, ventilation for respiratory failure CPAP for sleep apnoea | Device | Continuous positive airway pressure, Oxygen therapy, ventilation |
Primary outcome
death
Time frame: 20 years
long term follow up of a regularly updated database
1 secondary outcome
treatment adjustment
Time frame: 20 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2012.
- Results publication: PubMed 16162707Chambellan 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.
- Results publication: PubMed 12740261Chailleux 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.
- Results publication: PubMed 11468903Chailleux E, Boffa C. [Chronic respiratory insufficiency in France]. Rev Prat. 2001 May 31;51(10):1061-5. French.
- Results publication: PubMed 10706500Veale 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.
- Results publication: PubMed 9817145Veale 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.
- Results publication: PubMed 9812404Voisin C. [Medico-social management of severe respiratory insufficiency. Role of Associations]. Bull Acad Natl Med. 1998;182(6):1159-71; discussion 1172. French.
- Results publication: PubMed 8617085Chailleux 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.
- ANTADIR websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel VEALE, MD study director
ANTADIR scientific committee
Jean Francois MUIR, MD study chair
Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Respiratory Failure, run by Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Line Mounier, MSc (0033156814060, antadir@antadir.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
death (time frame: 20 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01181869, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2012.