Target Volume Mode Controlled Ventilator in Obesity Hypoventilation Syndrome

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Target Volume With a Pressure Controlled Ventilator in Obesity Hypoventilation Syndrome With Persistent Oxygen Desaturations With Continuous Positive Airway Pressure

Conditions
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Obesity Hypoventilation Syndrome

Intervention / Treatment
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* Device: Breas Vivo 40


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: NIV-PSV without Target Volume<br>Pressure Support Non Invasive Ventilation without Target Volume | Device: Breas Vivo 40<br>* The Vivo 40 will be used either in CPAP mode, PSV mode without Target Volume or PSV mode with Target Volume<br>* Other names: Breas Vivo 40 target volume;|
| Active Comparator: NIV-PSV with Target Volume<br>Non Invasive Pressure Support Ventilation with Target Volume set | Device: Breas Vivo 40<br>* The Vivo 40 will be used either in CPAP mode, PSV mode without Target Volume or PSV mode with Target Volume<br>* Other names: Breas Vivo 40 target volume;|
| Active Comparator: NIV-CPAP<br>Pressure Support Ventilation in CPAP mode | Device: Breas Vivo 40<br>* The Vivo 40 will be used either in CPAP mode, PSV mode without Target Volume or PSV mode with Target Volume<br>* Other names: Breas Vivo 40 target volume;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of daytime PaCO2 of NIV without target volume, with Target volume and with CPAP alone |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | 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) |  | 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 |