Redesigning Cardiac Surgery to Reduce Neurologic Injury

Surgery Clinical Trial

Official title:

Redesigning Cardiac Surgery to Reduce Neurologic Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00432536
• Other study ID #: 20307
• Secondary ID: 1K02HS015663-01A
• Status: Completed
• Phase: N/A
• First received: February 7, 2007
• Last updated: May 14, 2013
• Start date: October 2002
• Est. completion date: February 2012

Study information

• Verified date: May 2013
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 469
• Est. completion date: February 2012
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 89 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Surgery

Intervention

Other:
• Quality improvement intervention
determine the effectiveness of adopting quality improvement strategies to reduce embolization, hypotension and cerebral desaturation

Locations

Country	Name	City	State
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	Catholic Medical Center	Manchester	New Hampshire
United States	Maine Medical Center	Portland	Maine

Sponsors (9)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center	Agency for Healthcare Research and Quality (AHRQ), Catholic Medical Center, LivaNova, Luna Innovations, Maine Medical Center, Maquet Cardiovascular, Northern New England Cardiovascular Disease Study Group, Somanetics Corporation

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View Citation

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. — View Citation

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 — View Citation

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 b — View Citation

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. — View Citation

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 surge — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Emboli and Hypoperfusion Counts	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.	within the operative time period	No
Secondary	Type I and II neurologic injuries	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)	within 3 months after surgery	No
Secondary	Tissue-level neurologic injury	Blood for serum markers will be collected after surgery. We will assess plasma levels of biochemical markers of neurology injury.	within 48 hrs of surgery	No