Clinical trial NCT03215589: Assessment of Cerebral Blood Flow Asymmetry in Cardiac Surgery Patients Undergoing Hypothermic Circulatory Arrest
Official title: A Prospective Study of Cerebral Oximetry to Assess Symmetry of Cerebral Blood Flow and Clinical Outcomes in Cardiac Surgery Patients Undergoing Hypothermic Circulatory Arrest
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Cerebral Desaturation
Cerebral Ischemia
Keywords: Near-infrared spectroscopy-derived cerebral oximetry
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2017-07-12
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A convenience sample of 20 consecutive patients undergoing cardiac surgery employing CPB will be studied

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.

Eligibility criteria: Inclusion Criteria:

* Informed consent
* Age 18 years or older
* Surgery requiring cardio pulmonary bypass
* Ascending aorta or arch repair surgery
* Surgery requiring hypothermic circulatory arrest

Exclusion Criteria:

* Off-pump cardiac surgery
* Skin condition preventing the use of cerebral oximetry pads

Primary outcomes:
measure: Incidence of asymmetrical cerebral desaturation
timeFrame: Duration of hypothermic circulatory arrest between surgical induction and ICU admission
Secondary outcomes:
measure: Severity of asymmetrical cerebral desaturation
timeFrame: Duration of hypothermic circulatory arrest between surgical induction and ICU admission
measure: Severity of asymmetrical cerebral desaturation
timeFrame: Duration of hypothermic circulatory arrest between surgical induction and ICU admission
measure: All cause mortality
timeFrame: Surgical induction to 30 day postoperative
measure: Neurologic injury
timeFrame: Surgical induction to 30 day postoperative
measure: Renal injury
timeFrame: Surgical induction to 30 day postoperative
measure: Serious infection
timeFrame: Surgical induction to 30 day postoperative
measure: Gastrointestinal morbidity
timeFrame: Surgical induction to 30 day postoperative
measure: In-hospital mortality
timeFrame: Surgical induction to hospital discharge or 30 days postoperative, whichever comes first
measure: Hospital length of stay
timeFrame: Surgical induction to hospital discharge or 30 days postoperative, whichever comes first
measure: ICU length of stay
timeFrame: ICU admission to ICU discharge or 30 days postoperative, whichever comes first
measure: Intubation time
timeFrame: Time of surgical intubation to time of extubation
measure: Transfusions
timeFrame: Surgical induction to hospital discharge or 30 days postoperative, whichever comes first
measure: Renal function
timeFrame: Preoperative to hospital discharge or 30 days postoperative, whichever comes first
measure: Hemostatic support
timeFrame: ICU admission to hospital discharge or 30 days postoperative, whichever comes first
measure: Atrial fibrillation
timeFrame: ICU admission to hospital discharge or 30 days postoperative, whichever comes first
measure: Myocardial infarction
timeFrame: ICU admission to hospital discharge or 30 days postoperative, whichever comes first
measure: Atrial and/or ventricular arrhythmia
timeFrame: ICU admission to hospital discharge or 30 days postoperative, whichever comes first
measure: Nausea and vomiting
timeFrame: ICU admission to hospital discharge or 30 days postoperative, whichever comes first
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: St. Boniface Hospital
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Hilary P Grocott, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Murkin JM, Adams SJ, Novick RJ, Quantz M, Bainbridge D, Iglesias I, Cleland A, Schaefer B, Irwin B, Fox S. Monitoring brain oxygen saturation during coronary bypass surgery: a randomized, prospective study. Anesth Analg. 2007 Jan;104(1):51-8. doi: 10.1213/01.ane.0000246814.29362.f4.
citation: Fischer GW, Lin HM, Krol M, Galati MF, Di Luozzo G, Griepp RB, Reich DL. Noninvasive cerebral oxygenation may predict outcome in patients undergoing aortic arch surgery. J Thorac Cardiovasc Surg. 2011 Mar;141(3):815-21. doi: 10.1016/j.jtcvs.2010.05.017. Epub 2010 Jun 25.