Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
51 participants
INTERVENTIONAL
2017-06-09
2021-02-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Inhaled Anesthesia
Patients in the inhaled anesthesia arm will be given sevoflurane anesthesia maintenance for the duration of the procedure including cardiopulmonary bypass.
Sevoflurane
Volatile Anesthetic
Intravenous Anesthesia
Patients in the intravenous anesthesia arm will be given total intravenous anesthesia with propofol for the duration of the procedure including cardiopulmonary bypass.
Propofol
Intravenous Anesthetic
Interventions
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Sevoflurane
Volatile Anesthetic
Propofol
Intravenous Anesthetic
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Undergoing cardiac surgery with cardiopulmonary bypass
Exclusion Criteria
* History of severe COPD, emphysema, or ILD
* Recent (\<2wk) or current use of systemic glucocorticoids
* Prior history of pneumothorax
* Allergy/contraindication to intravenous anesthetics
* Personal or family history of malignant hyperthermia or high risk for malignant hyperthermia
18 Years
ALL
No
Sponsors
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Beth Israel Deaconess Medical Center
OTHER
Responsible Party
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Brian O'Gara
MD
Principal Investigators
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Brian O'Gara, MD
Role: PRINCIPAL_INVESTIGATOR
Beth Israel Deaconess Medical Center
Locations
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Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Countries
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References
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O'Gara B, Subramaniam B, Shaefi S, Mueller A, Banner-Goodspeed V, Talmor D. Anesthetics to Prevent Lung Injury in Cardiac Surgery (APLICS): a protocol for a randomized controlled trial. Trials. 2019 May 31;20(1):312. doi: 10.1186/s13063-019-3400-x.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2016P000306
Identifier Type: -
Identifier Source: org_study_id
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