NCT01181869

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 1983

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1983

Completed
27.6 years until next milestone

First Submitted

Initial submission to the registry

August 11, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 13, 2010

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

April 13, 2012

Status Verified

April 1, 2012

Enrollment Period

32 years

First QC Date

August 11, 2010

Last Update Submit

April 12, 2012

Conditions

Chronic Respiratory Failure

Keywords

respiratory failureoxygensleep apnoeaventilation

Outcome Measures

Primary Outcomes (1)

  • death

    long term follow up of a regularly updated database

    20 years

Secondary Outcomes (1)

  • treatment adjustment

    20 years

Study Arms (3)

Oxygen therapy

Database of patients on oxygen

Device: oxygen

ventilation

database of patients on ventilatory support

Device: oxygen

Continuous positive airway pressure

Sleep apnoea patients on CPAP

Device: oxygen

Interventions

oxygenDEVICE

oxygen therapy, ventilation for respiratory failure CPAP for sleep apnoea

Also known as: LTOT, NIV, CPAP
Continuous positive airway pressureOxygen therapyventilation

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients requiring respiratory support, in the ANTADIR homecare federation

You may qualify if:

  • requiring respiratory support

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ANTADIR

Paris, 75006, France

RECRUITING

Related Publications (7)

  • 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.

    PMID: 16162707RESULT

  • 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.

    PMID: 12740261RESULT

  • Chailleux E, Boffa C. [Chronic respiratory insufficiency in France]. Rev Prat. 2001 May 31;51(10):1061-5. French.

    PMID: 11468903RESULT

  • 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.

    PMID: 10706500RESULT

  • 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.

    PMID: 9817145RESULT

  • Voisin C. [Medico-social management of severe respiratory insufficiency. Role of Associations]. Bull Acad Natl Med. 1998;182(6):1159-71; discussion 1172. French.

    PMID: 9812404RESULT

  • 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.

    PMID: 8617085RESULT

Related Links

MeSH Terms

Conditions

Respiratory InsufficiencySleep Apnea SyndromesRespiratory Aspiration

Interventions

Oxygen Inhalation Therapy

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesApneaSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Respiratory TherapyTherapeutics

Study Officials

  • Daniel VEALE, MD

    ANTADIR scientific committee

    STUDY DIRECTOR

  • Jean Francois MUIR, MD

    Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche

    STUDY CHAIR

Central Study Contacts

Line Mounier, MSc

CONTACT

0033156814060antadir@antadir.com

Dan Veale, MD

CONTACT

0033156814060veale.dan@gmail.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Investigator

Study Record Dates

First Submitted

August 11, 2010

First Posted

August 13, 2010

Study Start

January 1, 1983

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

April 13, 2012

Record last verified: 2012-04

Locations

FR(1)