Redesigning Cardiac Surgery to Reduce Neurologic Injury
NCT ID: NCT00432536
Last Updated: 2013-05-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
469 participants
OBSERVATIONAL
2002-10-31
2012-02-29
Brief Summary
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The goal of this research is to identify modifiable clinical strategies and techniques of surgical and perfusion care associated with the causes (thrombotic/lipid emboli, cerebral hypoperfusion \& hypotension, and gaseous emboli) of neurologic injury secondary to coronary artery bypass graft (CABG) surgery, and subsequently to redesign these processes to reduce a patient's risk of a neurologic injury.
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Detailed Description
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Hypothesis #1a. Identifying alternative strategies for conducting processes of surgical and perfusion care will reveal opportunities to reduce the occurrence of causes of neurologic injury. The most common mechanisms creating neurologic injury, whether focal or global, after CABG surgery are thrombotic/lipid emboli, cerebral hypoperfusion \& hypotension, and gaseous emboli. Processes of surgical and perfusion care are associated with the creation of each of these causes of neurologic injury.
Hypothesis #1b. Redesigning processes of surgical and perfusion care to reduce thrombotic/lipid emboli, cerebral hypoperfusion \& hypotension, and gaseous emboli during CABG surgery will result in reductions of tissue-level and neurologic injury. We will analyze sera for tissue-level brain injury as well as identify any new neurologic injuries present among patients undergoing CABG surgery. Redesigning CABG surgery to reduce thrombotic/lipid emboli, cerebral hypoperfusion \& hypotension, and gaseous emboli will result in decreases in tissue-level and neurologic injury.
Hypothesis #2. A regional quality improvement intervention will result in changes to surgical and perfusion techniques. Regional dissemination of the findings from Hypotheses #1a,b may be realized through focused quality improvement initiatives utilizing multidisciplinary clinical teams.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Quality improvement intervention
determine the effectiveness of adopting quality improvement strategies to reduce embolization, hypotension and cerebral desaturation
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
40 Years
89 Years
ALL
No
Sponsors
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MaineHealth
OTHER
Catholic Medical Center
OTHER
Somanetics Corporation
INDUSTRY
LivaNova
INDUSTRY
Maquet Cardiovascular
INDUSTRY
Northern New England Cardiovascular Disease Study Group
UNKNOWN
Luna Innovations
INDUSTRY
Agency for Healthcare Research and Quality (AHRQ)
FED
Dartmouth-Hitchcock Medical Center
OTHER
Responsible Party
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David J. Malenka
Professor of Medicine
Principal Investigators
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Donald S Likosky, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Dartmouth-Hitchcock Medical Center
David J. Malenka, MD
Role: STUDY_DIRECTOR
Dartmouth-Hitchcock Medical Center
Locations
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Maine Medical Center
Portland, Maine, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Catholic Medical Center
Manchester, New Hampshire, United States
Countries
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References
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Likosky DS, Donegan DJ, Groom RC, Buchanan SA, Morton JR, Ross CS, O'Connor GT. Embolic activity subsequent to injection of the internal mammary artery with papaverine hydrochloride. Heart Surg Forum. 2005;8(6):E434-6. doi: 10.1532/HSF98.20051012.
Likosky DS, Groom RC, Clark C, Forest RJ, Kramer RS, Morton JR, Ross CS, Sabadosa KA, O'Connor GT; Northern New England Cardiovascular Disease Study Group, Lebanon, New Hampshire. A method for identifying mechanisms of neurologic injury from cardiac surgery. Heart Surg Forum. 2004;7(6):348-52. doi: 10.1532/HSF98.20041088.
Groom R, Likosky DS, Rutberg H. Understanding variation in cardiopulmonary bypass: Statistical Process Control Theory. J Extra Corpor Technol. 2004 Sep;36(3):224-30. No abstract available.
Groom RC, Likosky DS, Forest RJ, O'Connor GT, Morton JR, Ross CS, Clark C, Kramer R. A model for cardiopulmonary bypass redesign. Perfusion. 2004 Jul;19(4):257-61. doi: 10.1191/0269216304pf749oa.
Groom RC, Quinn RD, Lennon P, Welch J, Kramer RS, Ross CS, Beaulieu PA, Brown JR, Malenka DJ, O'Connor GT, Likosky DS; Northern New England Cardiovascular Disease Study Group. Microemboli from cardiopulmonary bypass are associated with a serum marker of brain injury. J Extra Corpor Technol. 2010 Mar;42(1):40-4.
Groom RC, Quinn RD, Lennon P, Donegan DJ, Braxton JH, Kramer RS, Weldner PW, Russo L, Blank SD, Christie AA, Taenzer AH, Forest RJ, Clark C, Welch J, Ross CS, O'Connor GT, Likosky DS; Northern New England Cardiovascular Disease Study Group. Detection and elimination of microemboli related to cardiopulmonary bypass. Circ Cardiovasc Qual Outcomes. 2009 May;2(3):191-8. doi: 10.1161/CIRCOUTCOMES.108.803163. Epub 2009 May 5.
Other Identifiers
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20307
Identifier Type: -
Identifier Source: org_study_id
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