Clinical Trial: Target Volume Mode Controlled Ventilator in Obesity Hypoventilation Syndrome
Study Status: Suspended
Recruit Status: Suspended
Study Type: Interventional
Official Title: Target Volume With a Pressure Controlled Ventilator in Obesity Hypoventilation Syndrome With Persistent Oxygen Desaturations With Continuous Positive Airway Pressure
Brief Summary: The purpose of this study is to investigate the evolution of daytime partial pressure of carbon dioxide in the blood (PaCO2) after 6 weeks of noninvasive ventilation-pressure support ventilation (NIV-PSV) with target volume versus continuous positive airway pressure (CPAP) alone versus NIV-PSV.
Detailed Summary: Compare the efficacy between 3 ventilation modes (CPAP, PSV and PSV with Target Volume) on patients with obesity hypoventilation syndrome already treated with CPAP but with persistent desaturations.
Sponsor: Breas Medical S.A.R.L.
Current Primary Outcome: Evolution of daytime PaCO2 of NIV without target volume, with Target volume and with CPAP alone [ Time Frame: 6 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Evolution in dyspnea scores (BDI/TDI and Simon Score) [ Time Frame: 6 weeks ]
- Evolution of subjective and objective sleepness (Osler) [ Time Frame: 6 weeks ]
- Cardiovascular parameters on Arterial strength (pulse velocity) and Endothelial function (Post ischemic test) [ Time Frame: 6 weeks ]
- Evolution of blood inflammation (IL6, TNFα et CRP) [ Time Frame: 6 weeks ]
- Evolution of insulin résistance [ Time Frame: 6 weeks ]
- Compliance (hours of treatment) [ Time Frame: 6 weeks ]
- Evolution of quality of ventilation (Leaks, asynchronism, others events) [ Time Frame: 6 weeks ]
- Sleep quality (PSG) between the 3 groups at 6 weeks [ Time Frame: 6 weeks ]
Original Secondary Outcome: Same as current
Information By: Breas Medical S.A.R.L.
Dates:
Date Received: April 14, 2010
Date Started: May 2009
Date Completion: May 2012
Last Updated: February 27, 2012
Last Verified: February 2012
