Assessment of Cerebral Blood Flow Asymmetry in Cardiac Surgery Patients Undergoing Hypothermic Circulatory Arrest
- Conditions
- Cerebral IschemiaCerebral Desaturation
- Registration Number
- NCT03215589
- Lead Sponsor
- University of Manitoba
- Brief Summary
Cerebral oxygen desaturation during cardiac surgery measured using near infrared spectroscopy (NIRS) derived cerebral oximetry has been associated with significant postoperative morbidity. If significant desaturation occurs during this period, it may represent an ideal opportunity to further optimize the postoperative care of these patients.
- Detailed Description
Selective antegrade cerebral perfusion (SACP) is a commonly used technique for maintaining cerebral blood flow (CBF) during the use of hypothermic cardiac arrest (HCA) for aortic arch reconstruction. However, even with an intact Circle of Willis, asymmetric CBF is a common occurrence during HCA when SACP is used. The investigators have previously shown that ultrasound guided extrinsic compression of the left carotid artery can increase left cerebral oxygen saturation, and improved symmetry of CBF; however, this has not been investigated formally. In this study, the investigators will firstly formally assess the incidence and severity of asymmetrical cerebral flow between the left and right hemispheres in patients undergoing aortic arch repair (n=20). CBF will be assessed indirectly through regional cerebral oxygen saturation (rSO2) measured via near-infrared spectroscopy-derived cerebral oximetry. In addition, a number of clinical outcome parameters (up to 30 days post-op) will be evaluated. The investigators expect that significant left-side cerebral hypoperfusion will consistently be observed in patients undergoing aortic arch repair using SACP.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 8
- Informed consent
- Age 18 years or older
- Surgery requiring cardio pulmonary bypass
- Ascending aorta or arch repair surgery
- Surgery requiring hypothermic circulatory arrest
- Off-pump cardiac surgery
- Skin condition preventing the use of cerebral oximetry pads
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of asymmetrical cerebral desaturation Duration of hypothermic circulatory arrest between surgical induction and ICU admission Cerebral desaturation defined as a greater than 10% difference in cerebral saturation comparing one hemisphere to the other based on a baseline reading taken in the minute preceding the onset of HCA to the end of the hypothermic period.
- Secondary Outcome Measures
Name Time Method All cause mortality Surgical induction to 30 day postoperative All cause mortality
Neurologic injury Surgical induction to 30 day postoperative Any neurologic injury, including: stroke, delirium, seizures, coma
Renal injury Surgical induction to 30 day postoperative Renal injury defined as a 50% decrease in estimated glomerular filtration rate (GFR) and/or need for dialysis
Gastrointestinal morbidity Surgical induction to 30 day postoperative Gastrointestinal (GI) morbidity defined as GI bleed, bowel perforation and/or ischemia
Serious infection Surgical induction to 30 day postoperative Serious infection including: mediastinitis, cellulitis, pneumonia, urinary tract infection
Renal function Preoperative to hospital discharge or 30 days postoperative, whichever comes first Greatest percent change in creatinine and 25% and 50% increase in creatinine
Nausea and vomiting ICU admission to hospital discharge or 30 days postoperative, whichever comes first Excess nausea and vomiting, requiring more than one drug therapy
Myocardial infarction ICU admission to hospital discharge or 30 days postoperative, whichever comes first Myocardial infarction as defined by:
Atrial and/or ventricular arrhythmia ICU admission to hospital discharge or 30 days postoperative, whichever comes first Atrial and/or ventricular arrhythmia, requiring electrical or pharmacologic intervention
Severity of asymmetrical cerebral desaturation Duration of hypothermic circulatory arrest between surgical induction and ICU admission Time under the curve (TUC) for all saturation events less than pre-induction baseline as well as for 10%, 15% and 25%, relative reductions under the baseline rSO2 will also be determined. In addition, the AUC and TUC for rSO2 less than an absolute rSO2 of 50% will also be determined.
In-hospital mortality Surgical induction to hospital discharge or 30 days postoperative, whichever comes first In hospital mortality
Hospital length of stay Surgical induction to hospital discharge or 30 days postoperative, whichever comes first The length of time (in days) that the patient remained in the hospital after surgery
ICU length of stay ICU admission to ICU discharge or 30 days postoperative, whichever comes first length of stay in the intensive care unit
Transfusions Surgical induction to hospital discharge or 30 days postoperative, whichever comes first The need for transfusions, including: red blood cells, platelets, plasma and cryoprecipitate
Intubation time Time of surgical intubation to time of extubation Duration of time that the patient was intubation from the start of surgery
Hemostatic support ICU admission to hospital discharge or 30 days postoperative, whichever comes first Requirement of vasopressors, intra-aortic balloon pumps (IABPs) and inotropes (0-12 hours, 12-24 hours and \>24 hours post-operative
Atrial fibrillation ICU admission to hospital discharge or 30 days postoperative, whichever comes first Atrial fibrillation
Trial Locations
- Locations (1)
St. Boniface Hospital
🇨🇦Winnipeg, Manitoba, Canada