Redesigning Cardiac Surgery to Reduce Neurologic Injury
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Purpose
Neurologic injuries are frequent and devastating complications following cardiac surgery. Previous work conducted by our research group and others has identified the principal mechanisms creating both overt and subtle neurologic injuries after cardiac surgery. Current work by our group has identified that the causes (thrombotic/lipid emboli, cerebral hypoperfusion & hypotension, and gaseous emboli) of these injuries are byproducts of processes of surgical and perfusion care. This insight suggests that the redesign of clinical strategies and techniques to prevent the occurrence of these intraoperative sources of damage may provide an opportunity to reduce the risk of neurologic injury after cardiac surgery.
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.
| Condition | Intervention |
|---|---|
|
Cardiovascular Disease Surgery |
Other: Quality improvement intervention |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Redesigning Cardiac Surgery to Reduce Neurologic Injury |
- Emboli and Hypoperfusion Counts [ Time Frame: within the operative time period ] [ Designated as safety issue: No ]We will count the number of thrombotic/lipid emboli and number of gaseous emboli. Along with the number of hypotensive events. We will link counts to surgical and perfusion techniques.
- Type I and II neurologic injuries [ Time Frame: within 3 months after surgery ] [ Designated as safety issue: No ]We will measure a patient's neurologic status Using a Telephone Interview for Cognitive Status tool at 3 time periods (prior to surgery, prior to discharge and at 3 months)
- Tissue-level neurologic injury [ Time Frame: within 48 hrs of surgery ] [ Designated as safety issue: No ]Blood for serum markers will be collected after surgery. We will assess plasma levels of biochemical markers of neurology injury.
Biospecimen Retention: Samples Without DNA
Serum to study neurologic biomarker, Sb100.
| Enrollment: | 469 |
| Study Start Date: | October 2002 |
| Study Completion Date: | February 2012 |
| Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
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Other: Quality improvement intervention
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. The following hypotheses will be addressed.
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.
Eligibility| Ages Eligible for Study: | 40 Years to 89 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients undergoing cardiac surgery.
Inclusion Criteria:
- Patients aged 40-89 years undergoing nonemergency coronary revascularization or valve procedures with or without the use of a cardiopulmonary bypass circuit.
Exclusion Criteria:
- Undergoing concomitant procedures besides cardiac surgery
Contacts and Locations| United States, Maine | |
| Maine Medical Center | |
| Portland, Maine, United States, 04102 | |
| United States, New Hampshire | |
| Dartmouth-Hitchcock Medical Center | |
| Lebanon, New Hampshire, United States, 03756 | |
| Catholic Medical Center | |
| Manchester, New Hampshire, United States, 03102 | |
| Principal Investigator: | Donald S Likosky, Ph.D. | Dartmouth-Hitchcock Medical Center |
| Study Director: | David J. Malenka, MD | Dartmouth-Hitchcock Medical Center |
More Information
Publications:
| Responsible Party: | David J. Malenka, Professor of Medicine, Dartmouth-Hitchcock Medical Center |
| ClinicalTrials.gov Identifier: | NCT00432536 History of Changes |
| Other Study ID Numbers: | 20307, 1K02HS015663-01A1 |
| Study First Received: | February 7, 2007 |
| Last Updated: | May 14, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Dartmouth-Hitchcock Medical Center:
|
Neuro-monitoring Quality Improvement Cerebral emboli Cerebral desaturation Hypotension |
Additional relevant MeSH terms:
|
Cardiovascular Diseases |
ClinicalTrials.gov processed this record on June 17, 2013