Skip to content

Redesigning Cardiac Surgery to Reduce Neurologic Injury

Redesigning Cardiac Surgery to Reduce Neurologic Injury

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00432536
Enrollment
469
Registered
2007-02-08
Start date
2002-10-31
Completion date
2012-02-29
Last updated
2013-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Disease, Surgery

Keywords

Neuro-monitoring, Quality Improvement, Cerebral emboli, Cerebral desaturation, Hypotension

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 (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.

Detailed 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.

Interventions

determine the effectiveness of adopting quality improvement strategies to reduce embolization, hypotension and cerebral desaturation

Sponsors

MaineHealth
CollaboratorOTHER
Catholic Medical Center
CollaboratorOTHER
Somanetics Corporation
CollaboratorINDUSTRY
LivaNova
CollaboratorINDUSTRY
Maquet Cardiovascular
CollaboratorINDUSTRY
Northern New England Cardiovascular Disease Study Group
CollaboratorUNKNOWN
Luna Innovations
CollaboratorINDUSTRY
Agency for Healthcare Research and Quality (AHRQ)
CollaboratorFED
Dartmouth-Hitchcock Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
40 Years to 89 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Emboli and Hypoperfusion Countswithin the operative time periodWe 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.

Secondary

MeasureTime frameDescription
Type I and II neurologic injurieswithin 3 months after surgeryWe 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 injurywithin 48 hrs of surgeryBlood for serum markers will be collected after surgery. We will assess plasma levels of biochemical markers of neurology injury.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026