Ignite Creation Date:
2024-05-05 @ 5:20 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00432536
Status:
COMPLETED
Last Update Posted:
2013-05-16
First Post:
2007-02-07
Brief Title:
Redesigning Cardiac Surgery to Reduce Neurologic Injury
Sponsor:
Dartmouth-Hitchcock Medical Center
Organization:
Dartmouth-Hitchcock Medical Center
Study Overview
Official Title:
Redesigning Cardiac Surgery to Reduce Neurologic Injury
Status:
COMPLETED
Status Verified Date:
2013-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 thromboticlipid 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 thromboticlipid 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 patients risk of a neurologic injury
The goal of this research is to identify modifiable clinical strategies and techniques of surgical and perfusion care associated with the causes thromboticlipid 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 patients risk of a neurologic injury
Detailed Description:
The goal of this research is to identify modifiable clinical strategies and techniques of surgical and perfusion care associated with the causes thromboticlipid 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 patients 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 thromboticlipid 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 thromboticlipid 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 thromboticlipid 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 1ab may be realized through focused quality improvement initiatives utilizing multidisciplinary clinical teams
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 thromboticlipid 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 thromboticlipid 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 thromboticlipid 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 1ab may be realized through focused quality improvement initiatives utilizing multidisciplinary clinical teams
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1K02HS015663-01A1 | AHRQ | None | httpsreporternihgovquickSearch1K02HS015663-01A1 |