Informations générales (source: ClinicalTrials.gov)
Initiation of Non- Invasive Ventilation at Home Versus Hospital Among Patients With Overlap Syndrome: Randomized Controlled Non-inferiority Study (OVNI-Dom)
Interventional
N/A
IP Santé Domicile (Voir sur ClinicalTrials)
février 2015
mars 2016
29 juin 2024
The study is based on the assumption that in the Overlap Syndrome, the introduction at
home of the NIV is as effective in terms of compliance and clinical and gazometric
improvement, and life quality, that setting hospital start up. The investigators will
study the initiation of NIV at home versus in hospital in two randomized Overlap Syndrome
patient groups. The main objective of the study is to demonstrate the non-inferiority of
the initiation of the NIV at home versus hospital in terms of compliance.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CH BICHAT MAISON BLANCHE | Marie Pia d'ORTHO, MD | Contact (sur clinicalTrials) | |||
| CPEF LE BLANC MESNIL | Naim FOURAR, MD | Contact (sur clinicalTrials) | |||
| IFSI DE L'HÔPITAL RAYMOND POINCARÉ | David ORLIKOWSKI, MD | Contact (sur clinicalTrials) | |||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Hospitalier Haguenau - 67500 - Haguenau - France | Parisa ASSEMI, MD | Contact (sur clinicalTrials) | |||
| CH Annecy-Genevois - 74374 - Annecy - France | Taoufik DIDI, MD | Contact (sur clinicalTrials) | |||
| CH Intercommunal du Val d'Ariège - 09017 - Foix - France | Abdelkader GHAZI, MD | Contact (sur clinicalTrials) | |||
| CHR - Hôpital Calmette - 59037 - Lille - France | Stéphanie FRY, MD | Contact (sur clinicalTrials) | |||
| CHU de Grenoble site Nord - Hôpital Albert Michallon - 38043 - Grenoble - France | Jean-louis PEPIN, MD | Contact (sur clinicalTrials) | |||
| CHU de Strasbourg - Hôpital Civil - 67091 - Strasbourg - France | Romain KESSLER, MD | Contact (sur clinicalTrials) | |||
| CHU Dijon - 21000 - Dijon - France | Claudio RABEC, MD | Contact (sur clinicalTrials) | |||
| Clinique Mutualiste du Medoc - 33340 - Lesparre - France | Nathalie RAYMOND, MD | Contact (sur clinicalTrials) | |||
| Clinique Saint Laurent - 35700 - Rennes - France | Arnaud PRIGENT, MD | Contact (sur clinicalTrials) | |||
| Institut Arnault Tzanck - 06721 - Saint Laurent du Var - France | Guy-René BOYER, MD | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CH Cannes - 06401 - Cannes - France | Christophe PERRIN, MD | Contact (sur clinicalTrials) | |||
| CHU La Pitié-salpétrière - 75651 - Paris - France | Jésus GONZALEZ, MD | Contact (sur clinicalTrials) | |||
| Clinique Chirurgicale Bel-Air - 33073 - Bordeaux - France | Nathalie RAYMOND, MD | Contact (sur clinicalTrials) | |||
| Hôpital Larrey CHU Toulouse - 31053 - Toulouse - France | Kamila SEDKAOUI, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- Major patients, of less than 80 years
- Patients with chronic respiratory failure within a Overlap syndrome ( defined by the
coexistence of COPD and OAS ) in stable situation (no exacerbation for at least 4
weeks) , indication for a NIV treatment
- OAS confirmed by polysomnography according to the standards of the American Academy
of Sleep Medicine ( AASM ) with an AHI> 15, the central apneas are tolerated if <
20%
- COPD defined by obstruction of the air flow : VEMS/CVF <70 % and VEMS <80% of the
average value predicted
- Started criteria of NIV: chronic respiratory failure within an Overlap Syndrome and
PaCO2 > 45 mmHg (at rest on room air ) and / or medium PtCO2 > 50 mmHg
- Patient informed of the study and who signed an informed consent
- Major patients, of less than 80 years
- Patients with chronic respiratory failure within a Overlap syndrome ( defined by the
coexistence of COPD and OAS ) in stable situation (no exacerbation for at least 4
weeks) , indication for a NIV treatment
- OAS confirmed by polysomnography according to the standards of the American Academy
of Sleep Medicine ( AASM ) with an AHI> 15, the central apneas are tolerated if <
20%
- COPD defined by obstruction of the air flow : VEMS/CVF <70 % and VEMS <80% of the
average value predicted
- Started criteria of NIV: chronic respiratory failure within an Overlap Syndrome and
PaCO2 > 45 mmHg (at rest on room air ) and / or medium PtCO2 > 50 mmHg
- Patient informed of the study and who signed an informed consent
- Patients already treated for OAS in the year
- Patient tracheotomised
- Other diseases with respiratory involvement : neuromuscular disease , restrictive
disease of the chest with CPT <80% , apnea syndrome pure central sleep ( central
apnea are tolerated if < 20% )
- Lung cancer within the last 5 years
- Uncontrolled psychic diseases
- Acute respiratory failure requiring NIV , going back a month
- Clinical situation requiring prolonged hospitalization
- Patients with no opportunity to understand and follow instructions
- Refusal to participate in the study
- Lack of insurance coverage
- Pregnant and / or nursing