Comparison of Two Noninvasive Positive Pressure Ventilation Devices Using Target Volume Modes in Obesity Hypoventilation Syndrome (OHS): A Pilot Randomized Crossover Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Mean Nocturnal transcutaneous CO2 pressure (Mean nocturnal PtCO2)
Study Overview
Brief Summary
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
RESMED Stellar-150 (IVAPS mode)versus PHILIPS-RESPIRONICS A30 (AVAPS-mode).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
AVAPS
AVAPS mode(BIPAP-A30-PHILIPS-RESPIRONICS)1 night
Intervention: IVAPS (Device)
IVAPS
IVAPS mode(STELAR 150-RESMED)1 night
Intervention: AVAPS (Device)
Outcomes
Primary Outcomes
Mean Nocturnal transcutaneous CO2 pressure (Mean nocturnal PtCO2)
Time Frame: 1 night
transcutaneous CO2 pressure is measured overnight. It is a reliable estimation of arterial PaCO2 to monitor nocturnal ventilation in adults with chronic respiratory failure.
Secondary Outcomes
- Mean transcutaneous CO2 pressure during REM Sleep(1 Night)
- Mean nocturnal SpO2(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)
- Awake arterial PaCO2 after 1 hour of NIPPV withdrawal(After 1 night)