Non Invasive Ventilation : Efficacy of a New Ventilatory Mode in Patients With OHS
In 2012, Philips Respironics has announced the availability of the new bi-level 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 doubled-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 ventilation pattern, gas exchange, sleep quality, symptoms, level of physical activity and health-related quality of life in OHS patients.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Clinical Benefits and Tolerance to a New Ventilatory Mode in Patients With Obesity Hypoventilation Syndrom (OHS).|
- CHANGE IN SLEEP QUALITY [ Time Frame: Day 1 and Day 61 ] [ Designated as safety issue: Yes ]Sleep stage, micro arousals, apnea/hypopnea index...
- CHANGE IN GAZ EXCHANGE [ Time Frame: Day 1 and Day 61 ] [ Designated as safety issue: Yes ]PaO2, PaCO2
- CHANGE IN QUALITY OF LIFE [ Time Frame: Day 1 and Day 61 ] [ Designated as safety issue: Yes ]
|Study Start Date:||February 2013|
|Estimated Study Completion Date:||February 2015|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
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.