CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 90 enrolled
Drug / intervention
AVAPS-AE Mode of Therapy +2 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01368614
NCT01368614N/ACompleted
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Randomized Controlled Trial Evaluating the Feasibility of AVAPS-AE vs. CPAP vs.Bilevel Pressure Support Ventilation in Obesity Hypoventilation Syndrome

Philips Respironics·interventional·Posted Jun 8, 2011·Updated Apr 26, 2019

In Brief

A clinical study evaluating AVAPS-AE Mode of Therapy, Respironics OnmiLab BiPAP S mode, and 1 other intervention for Obesity Hypoventilation Syndrome. Completed, enrolled 90 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsObesity Hypoventilation Syndrome
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJun 8, 2011
Enrollment StartSep 12, 2011
Primary CompletionMay 30, 2013
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 15.1 years ago

Interventions

AVAPS-AE Mode of Therapydevice

AVAPS-AE mode is the experimental mode of therapy in this study that includes a combination of already cleared therapy attributes.

Respironics OnmiLab BiPAP S modedevice

Currently cleared Non-Invasive Ventilation (NIV) therapy modality

Respironics OmniLab Advanced CPAP modedevice

Currently cleared NIV therapy modality