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AVAPS-AE Efficacy Study

NCT01368614 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2019-04-26

Study results available
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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

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

Sponsors & Collaborators

  • Philips Respironics

    lead INDUSTRY

Principal Investigators

  • Sairam Parthasarathy, MD · Southern Arizona VA Healthcare

  • Babak Mokhlesi, MD · University of Chicago

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-12
Primary Completion
2013-05-30
Completion
2013-05-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01368614 on ClinicalTrials.gov