Target Volume in Noninvasive Positive Pressure Ventilation

Study Overview
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Brief Summary
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Patients with OHS are efficiently managed with long term home-based nocturnal noninvasive positive pressure ventilation (NIPPV). Several NIPPV devices offer the feature of automatically adjusting pressure support (and/or respiratory back-up rate) on the basis of a pre-determined ideal tidal volume or ideal ventilation. However algorithms used to achieve these ideal targets are different among different commercialized devices and the relative efficacy from an algorithm compared to another remains unknown. The main objective is this study is to compare two commercialized NIPPV that have this option

Detailed Description
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RESMED Stellar-150 (IVAPS mode)versus PHILIPS-RESPIRONICS A30 (AVAPS-mode).

Official Title
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Comparison of Two Noninvasive Positive Pressure Ventilation Devices Using Target Volume Modes in Obesity Hypoventilation Syndrome (OHS): A Pilot Randomized Crossover Controlled Trial

Conditions
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Obesity Hypoventilation Syndrome

Intervention / Treatment
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* Device: IVAPS
* Device: AVAPS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient with Obesity hypoventilation Syndrome (BMI≥ 30 kg/m2 and diurnal PaCO2 ≥ 45mmHg at diagnosis after exclusion of others causes of hypoventilation) 18 to 75 years old In stable state but treated by nocturnal NIPPV for more than 3 months and adherent to NIPPV (above 4h/night). Exclusion Criteria: patient treated with additional long term Oxygen therapy Patient previously treated by AVAPS mode or IVAPS mode

Ages Eligible for Study
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Minimum Age: 18 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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: AVAPS<br>AVAPS mode(BIPAP-A30-PHILIPS-RESPIRONICS)1 night | Device: IVAPS<br>* IVAPS mode (RESMED Stelar 150) during 1 night<br>|
| Active Comparator: IVAPS<br>IVAPS mode(STELAR 150-RESMED)1 night | Device: AVAPS<br>* AVAPS mode (PHILIPS-RESPIRONICS-A30) during 1 night<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Nocturnal transcutaneous CO2 pressure (Mean nocturnal PtCO2) | transcutaneous CO2 pressure is measured overnight. It is a reliable estimation of arterial PaCO2 to monitor nocturnal ventilation in adults with chronic respiratory failure. | 1 night | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean transcutaneous CO2 pressure during REM Sleep |  | 1 Night | 
| Mean nocturnal SpO2 |  | 1 night | 
| Awake arterial PaCO2 after 1 hour of NIPPV withdrawal |  | After 1 night | 
| Micro-arousals/hour of sleep |  | 1 night | 
| Sleep Quality assess by Visual analogic scale (100mm) |  | 1 night | 
| Respiratory residual events detected by NIPPV built-in softwares |  | 1 Night | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Noninvasive ventilation, Obesity Hypoventilation Syndrome