EIT Assessment of Lung Volume and Tidal Distribution: A Comparison of Non-Invasive Ventilation Devices
NCT ID: NCT02930174
Last Updated: 2019-05-14
Study Results
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View full resultsBasic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2018-02-01
2018-03-27
Brief Summary
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Detailed Description
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A technique introduced in the 1980's, electrical impedance tomography (EIT), can non-invasively provide similar monitoring of lung function, and without the exposure to radiation. This imaging technique applies small alternating currents of electricity to surface electrodes to construct cross-sectional images of the lung.
Over that past several decades EIT has moved from the research lab to commercially available devices that are used at the bedside. EIT has also been applied to study the effects of various devices used to provide non-invasive ventilation. EIT may prove useful to optimally adjust non-invasive ventilation settings to improve ventilation and oxygenation. One such EIT system is manufactured by Draeger Medical. It is available in Europe and Canada but is not yet FDA approved for use in the United States.
This study is being done with healthy volunteers to further the investigators' knowledge of the EIT system and to see if measures between two non-invasive ventilation systems routinely used clinically are equivalent.
As this is a preliminary study looking at the EIT system vs 2 other devices, outcomes measures may be modified as the study progresses.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
NONE
Study Groups
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Respironics V-60, then Draeger V500
Testing by applying noninvasive positive pressure ventilation (NPPV) via two different bilevel positive airway pressure (BiPAP) devices . Arm one applies the Respironics V-60, then the Drager V-500.
noninvasive positive pressure ventilation
Application of various levels of positive pressure
Draeger V500, then Respironics V-60
Testing by applying noninvasive positive pressure ventilation (NPPV) via two different bilevel positive airway pressure (BiPAP) devices . Arm two applies the Drager V-500, then the Respironics V-60.
noninvasive positive pressure ventilation
Application of various levels of positive pressure
Interventions
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noninvasive positive pressure ventilation
Application of various levels of positive pressure
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
Yes
Sponsors
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University of Michigan
OTHER
Responsible Party
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Carl Haas
Education & Research Coordinator, Respiratory Care
Principal Investigators
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Carl Haas, MLS
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Locations
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University of Michigan
Ann Arbor, Michigan, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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HUM00102144
Identifier Type: -
Identifier Source: org_study_id
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