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Redesigning Cardiac Surgery to Reduce Neurologic Injury

Dartmouth Health logo

Dartmouth Health

Status

Completed

Conditions

Surgery
Cardiovascular Disease

Treatments

Other: Quality improvement intervention

Study type

Observational

Funder types

Other
Other U.S. Federal agency
Industry

Identifiers

NCT00432536
20307
1K02HS015663-01A1 (U.S. AHRQ Grant/Contract)

Details and patient eligibility

About

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.

Full description

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.

Enrollment

469 patients

Sex

All

Ages

40 to 89 years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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