EIT Assessment of Lung Volume and Tidal Distribution: A Comparison of Non-Invasive Ventilation Devices
1 other identifier
interventional
20
1 country
1
Brief Summary
This study is being done 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 24, 2015
CompletedFirst Posted
Study publicly available on registry
October 12, 2016
CompletedStudy Start
First participant enrolled
February 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 27, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 27, 2018
CompletedResults Posted
Study results publicly available
April 22, 2019
CompletedMay 14, 2019
May 1, 2019
2 months
August 24, 2015
March 22, 2019
May 3, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Global Tidal Variation (TID)
TID is the distribution of ventilation for a breath averaged over a defined section, the entire lung. TID is analogous to the tidal volume. Baseline is defined to be 100% and other measures are in comparison to baseline (eg, a value of 102 represents a 2% increase from baseline).
1 day
Secondary Outcomes (5)
Regional Tidal Variation: Dorsal
1 day
Regional Tidal Variation: Ventral
1 day
Global Change in End-expiratory Lung Impedance (EELI)
1 day
Regional Change in EELI: Dorsal
1 day
Regional Change in EELI: Ventral
1 day
Study Arms (2)
Respironics V-60, then Draeger V500
ACTIVE COMPARATORTesting 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.
Draeger V500, then Respironics V-60
ACTIVE COMPARATORTesting 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.
Interventions
Application of various levels of positive pressure
Eligibility Criteria
You may qualify if:
- Age 18 years or older
You may not qualify if:
- Use of a cardiac pacemaker, an implantable cardioverter-defibrillator (ICD) or any other active implants
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Michigan
Ann Arbor, Michigan, 48109, United States
Results Point of Contact
- Title
- Carl Haas
- Organization
- University of Michigan Health System
Study Officials
- PRINCIPAL INVESTIGATOR
Carl Haas, MLS
University of Michigan
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Education & Research Coordinator, Respiratory Care
Study Record Dates
First Submitted
August 24, 2015
First Posted
October 12, 2016
Study Start
February 1, 2018
Primary Completion
March 27, 2018
Study Completion
March 27, 2018
Last Updated
May 14, 2019
Results First Posted
April 22, 2019
Record last verified: 2019-05