Non Invasive Ventilation : Efficacy of a New Ventilatory Mode in Patients With OHS
Study Details
Study Description
Brief Summary
In 2012, it has announced the availability of the new ventilator (BiPAP- A40), which could offer potential advantages over fixed level pressure support, in particular, in patients with obesity hypoventilation syndrome (OHS). One of the key benefits of the BiPAP A40 is an innovative ventilation mode called AVAPS-AE, which automatically maintains airway patency while delivering the correct level of ventilation each user requires, whatever their body position or sleep stage. AVAPS-AE mode is also aimed to help the clinicians during the initial titration of therapy, while providing long term comfort and assuring therapy compliance. However, studies on the physiologic and clinical effects have not yet been performed. The aim of our singled-blind randomised multicentre controlled trial is to prospectively investigate the effects of BiPAP with the spontaneous/timed (S/T) or the AVAPS-AE ventilation mode over 8 weeks on sleep quality, ventilation pattern, gas exchange, symptoms, body composition, level of physical activity and health-related quality of life in OHS patients.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Efficacy on sleep quality, symptoms, physical activity and quality of life
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: BiPAP - A40 BiPAP with AVAPS AE mode |
Device: BiPAP - A40
Patients receiving BiPAP AVAPS - AE ventilatory mode at home
|
| Active Comparator: BiPAP- ST Patients receiving BiPAP- ST at home |
Device: BiPAP - ST
Patients receiving BiPAP- ST mode at home.
|
Outcome Measures
Primary Outcome Measures
- CHANGE IN SLEEP QUALITY [Day 1 and Day 61]
Sleep stage, micro arousals, apnea/hypopnea index...
Secondary Outcome Measures
- CHANGE IN GAZ EXCHANGE [Day 1 and Day 61]
Other Outcome Measures
- CHANGE IN QUALITY OF LIFE/ LEVEL OF PHYSICAL ACTIVITY/ BODY COMPOSITION [Day 1 and Day 61]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Man or woman, stable patient with obesity hypoventilation syndrome, naives of non invasive ventilation.
-
PaCO2 ≥ 45 mmHg.
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PaO2 < 70 mmHg
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BMI ≥ 30Kg. m2
Exclusion Criteria:
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Chronic obstructive pulmonary disease
-
Neuromuscular disease
-
Scoliosis
-
Cardiac insufficiency
-
Significant psychiatric disease
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Sleep apnea syndrome with central apnea index > 10%
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Treatment with benzodiazepines at the inclusion
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Centre Hospitalier Universitaire d'Angers | Angers | France | ||
| 2 | Centre Hospitalier de Béziers | Beziers | France | ||
| 3 | Hôpital Haut- Lévêque | Bordeaux | France | ||
| 4 | Centre Hospitalier de Cannes | Cannes | France | ||
| 5 | Clinique du Parc | Castelnau-le-Lez | France | ||
| 6 | Hôpital du Bocage | Dijon | France | ||
| 7 | Hôpital Michallon | Grenoble | France | ||
| 8 | Hôpital Pitié-Salpêtrière | Paris | France | ||
| 9 | Hôpital La Milétrie | Poitiers | France | ||
| 10 | Hôpital de Bois Guillaume | Rouen | France | ||
| 11 | Hôpital Larrey | Toulouse | France |
Sponsors and Collaborators
- Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche
Investigators
- Principal Investigator: Jean-François MUIR, Pr, Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2012 - A00731 - 42
- EVAL CLIN - VENTILATEUR