Obesity Hypoventilation Syndrome Clinical Trial
— OVOOfficial title:
Target Volume With a Pressure Controlled Ventilator in Obesity Hypoventilation Syndrome With Persistent Oxygen Desaturations With Continuous Positive Airway Pressure
Verified date | July 2017 |
Source | Breas Medical S.A.R.L. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | May 2012 |
Est. primary completion date | May 2012 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Patients from 20 to 75 years old. - Body mass index > 32 kg/m2 - Nocturnal oxygen desaturation 5 mn = 88% under CPAP, - PaCO2 > 5,9 kPa in diurnal, spontaneous ventilation Exclusion Criteria: - Patients with COPD and VEMS/FVC < 65% - Patients with CHF and periodic breathing (Ejection Fraction <40%) - Patients with a recent respiratory decompensation in the month preceding inclusion |
Country | Name | City | State |
---|---|---|---|
France | CHU | Grenoble | |
France | GH Pitié-Salpétrière - Service de pneumologie et réanimation | Paris cedex 13 |
Lead Sponsor | Collaborator |
---|---|
Breas Medical S.A.R.L. |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evolution of daytime PaCO2 of NIV without target volume, with Target volume and with CPAP alone | 6 weeks | ||
Secondary | Evolution in dyspnea scores (BDI/TDI and Simon Score) | 6 weeks | ||
Secondary | Evolution of subjective and objective sleepness (Osler) | 6 weeks | ||
Secondary | Cardiovascular parameters on Arterial strength (pulse velocity) and Endothelial function (Post ischemic test) | 6 weeks | ||
Secondary | Evolution of blood inflammation (IL6, TNFa et CRP) | 6 weeks | ||
Secondary | Evolution of insulin résistance | 6 weeks | ||
Secondary | Compliance (hours of treatment) | 6 weeks | ||
Secondary | Evolution of quality of ventilation (Leaks, asynchronism, others events) | 6 weeks | ||
Secondary | Sleep quality (PSG) between the 3 groups at 6 weeks | 6 weeks |
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