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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NIV-PSV without Target Volume | Active Comparator | Pressure Support Non Invasive Ventilation without Target Volume |
|
| NIV-PSV with Target Volume | Active Comparator | Non Invasive Pressure Support Ventilation with Target Volume set |
|
| NIV-CPAP | Active Comparator | Pressure Support Ventilation in CPAP mode |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Breas Vivo 40 | Device | The Vivo 40 will be used either in CPAP mode, PSV mode without Target Volume or PSV mode with Target Volume |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evolution of daytime PaCO2 of NIV without target volume, with Target volume and with CPAP alone | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Evolution in dyspnea scores (BDI/TDI and Simon Score) | 6 weeks | |
| Evolution of subjective and objective sleepness (Osler) | 6 weeks | |
| Cardiovascular parameters on Arterial strength (pulse velocity) and Endothelial function (Post ischemic test) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Louis Pepin, prof | University Hospital, Grenoble | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU | Grenoble | France | ||||
| GH Pitié-Salpétrière - Service de pneumologie et réanimation |
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| ID | Term |
|---|---|
| D010845 | Obesity Hypoventilation Syndrome |
| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
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|
| 6 weeks |
| Evolution of blood inflammation (IL6, TNFα et CRP) | 6 weeks |
| Evolution of insulin résistance | 6 weeks |
| Compliance (hours of treatment) | 6 weeks |
| Evolution of quality of ventilation (Leaks, asynchronism, others events) | 6 weeks |
| Sleep quality (PSG) between the 3 groups at 6 weeks | 6 weeks |
| Paris |
| 75651 |
| France |
| D012140 |
| Respiratory Tract Diseases |
| D007040 | Hypoventilation |
| D012131 | Respiratory Insufficiency |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |