NCT01368614

AVAPS-AE Efficacy Study

Randomized Controlled Trial Evaluating the Feasibility of AVAPS-AE vs. CPAP vs.Bilevel Pressure Support Ventilation in Obesity Hypoventilation Syndrome

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Philips Respironics · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the feasibility of using of the Average Volume Assured Pressure Support (AVAPS-AE) mode versus Continuous Positive Airway Pressure (CPAP) and bilevel pressure support ventilation (PSV) modes of ventilation in patients diagnosed with Obesity Hypoventilation syndrome (OHS). The investigators believe the use of the AVAPS-AE mode of ventilation after 6 weeks will yield daytime gas exchange values which are equivalent or no worse when compared to using CPAP and bilevel PSV modes of ventilation in the OHS population.

Conditions

• Obesity Hypoventilation Syndrome

Interventions

Type	Name	Description
DEVICE	AVAPS-AE Mode of Therapy	AVAPS-AE mode is the experimental mode of therapy in this study that includes a combination of already cleared therapy attributes.
DEVICE	Respironics OnmiLab BiPAP S mode	Currently cleared Non-Invasive Ventilation (NIV) therapy modality
DEVICE	Respironics OmniLab Advanced CPAP mode	Currently cleared NIV therapy modality

Timeline

• Start date: 2011-09-12
• Primary completion: 2013-05-30
• Completion: 2013-05-30
• First posted: 2011-06-08
• Last updated: 2019-04-26
• Results posted: 2019-04-26

Locations

2 sites across 1 country: United States