Electrical Impedance Tomography for Optimization of Positive End-Expiratory Pressure: Acute Respiratory Distress Syndrome
NCT ID: NCT03793842
Last Updated: 2023-10-12
Study Results
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View full resultsBasic Information
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COMPLETED
NA
16 participants
INTERVENTIONAL
2019-03-04
2022-06-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Usual care then PEEP titration by Electrical Impedance Tomography (EIT)
Patients in the usual care first group will continue to receive mechanical ventilation according to the University of Michigan Acute Respiratory Distress Syndrome (ARDS) protocol high-PEEP arm
Usual care
Intervention is the standard basic lung protective ventilation strategy used at the University Hospital Respiratory Care at Michigan Medicine.
PEEP titration by EIT
PEEP Titration procedure involves two phases: a recruitment phase followed by a gradual reduction in the end-expiratory pressure phase (Decremental PEEP).
PEEP titration by EIT then usual care
Patients in the high PEEP titration by EIT first will have receive ventilation with a PEEP determined by EIT titration procedure.
Usual care
Intervention is the standard basic lung protective ventilation strategy used at the University Hospital Respiratory Care at Michigan Medicine.
PEEP titration by EIT
PEEP Titration procedure involves two phases: a recruitment phase followed by a gradual reduction in the end-expiratory pressure phase (Decremental PEEP).
Interventions
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Usual care
Intervention is the standard basic lung protective ventilation strategy used at the University Hospital Respiratory Care at Michigan Medicine.
PEEP titration by EIT
PEEP Titration procedure involves two phases: a recruitment phase followed by a gradual reduction in the end-expiratory pressure phase (Decremental PEEP).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Presence of all of the following conditions for \< 48 hours i. Partial pressure of oxygen to percentage of inspired oxygen (PaO2/FiO2) \< 150 with PEEP \> 5 cm water for \> 30 min.
ii. bilateral opacities not fully explained by effusions, lobar/lung collapse, or nodules iii. respiratory failure not fully explained by cardiac failure or fluid overload
-All criteria listed in (3) developed within 1 week of a known clinical insult or new or worsening respiratory symptoms
Exclusion Criteria
* Known pregnancy
* Extracorporeal membrane oxygenation (ECMO) use
* Severe chronic respiratory disease requiring home oxygen therapy or ventilation
* Calculated BMI of greater than 50
18 Years
ALL
No
Sponsors
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University of Michigan
OTHER
Responsible Party
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Robert C. Hyzy, MD
Professor of Internal Medicine
Principal Investigators
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Robert Hyzy, MD
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Locations
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The University of Michigan
Ann Arbor, Michigan, United States
Countries
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References
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Jimenez JV, Munroe E, Weirauch AJ, Fiorino K, Culter CA, Nelson K, Labaki WW, Choi PJ, Co I, Standiford TJ, Prescott HC, Hyzy RC. Electric impedance tomography-guided PEEP titration reduces mechanical power in ARDS: a randomized crossover pilot trial. Crit Care. 2023 Jan 17;27(1):21. doi: 10.1186/s13054-023-04315-x.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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HUM00148126
Identifier Type: -
Identifier Source: org_study_id
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