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Assessment of Cerebral Blood Flow Asymmetry in Cardiac Surgery Patients Undergoing Hypothermic Circulatory Arrest

A Prospective Study of Cerebral Oximetry to Assess Symmetry of Cerebral Blood Flow and Clinical Outcomes in Cardiac Surgery Patients Undergoing Hypothermic Circulatory Arrest

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03215589
Acronym
COASTLINE
Enrollment
8
Registered
2017-07-12
Start date
2017-07-03
Completion date
2018-12-31
Last updated
2020-02-17

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

Conditions

Cerebral Desaturation, Cerebral Ischemia

Keywords

Near-infrared spectroscopy-derived cerebral oximetry

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.

Interventions

None listed

Sponsors

University of Manitoba
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of asymmetrical cerebral desaturationDuration of hypothermic circulatory arrest between surgical induction and ICU admissionCerebral 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

MeasureTime frameDescription
TransfusionsSurgical induction to hospital discharge or 30 days postoperative, whichever comes firstThe need for transfusions, including: red blood cells, platelets, plasma and cryoprecipitate
Renal functionPreoperative to hospital discharge or 30 days postoperative, whichever comes firstGreatest percent change in creatinine and 25% and 50% increase in creatinine
Severity of asymmetrical cerebral desaturationDuration of hypothermic circulatory arrest between surgical induction and ICU admissionArea of the curve (AUC) and 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.
All cause mortalitySurgical induction to 30 day postoperativeAll cause mortality
Neurologic injurySurgical induction to 30 day postoperativeAny neurologic injury, including: stroke, delirium, seizures, coma
Renal injurySurgical induction to 30 day postoperativeRenal injury defined as a 50% decrease in estimated glomerular filtration rate (GFR) and/or need for dialysis
Serious infectionSurgical induction to 30 day postoperativeSerious infection including: mediastinitis, cellulitis, pneumonia, urinary tract infection
Gastrointestinal morbiditySurgical induction to 30 day postoperativeGastrointestinal (GI) morbidity defined as GI bleed, bowel perforation and/or ischemia
Intubation timeTime of surgical intubation to time of extubationDuration of time that the patient was intubation from the start of surgery
Hospital length of staySurgical induction to hospital discharge or 30 days postoperative, whichever comes firstThe length of time (in days) that the patient remained in the hospital after surgery
ICU length of stayICU admission to ICU discharge or 30 days postoperative, whichever comes firstlength of stay in the intensive care unit
Hemostatic supportICU admission to hospital discharge or 30 days postoperative, whichever comes firstRequirement of vasopressors, intra-aortic balloon pumps (IABPs) and inotropes (0-12 hours, 12-24 hours and \>24 hours post-operative
Atrial fibrillationICU admission to hospital discharge or 30 days postoperative, whichever comes firstAtrial fibrillation
Myocardial infarctionICU admission to hospital discharge or 30 days postoperative, whichever comes firstMyocardial infarction as defined by:
Atrial and/or ventricular arrhythmiaICU admission to hospital discharge or 30 days postoperative, whichever comes firstAtrial and/or ventricular arrhythmia, requiring electrical or pharmacologic intervention
Nausea and vomitingICU admission to hospital discharge or 30 days postoperative, whichever comes firstExcess nausea and vomiting, requiring more than one drug therapy
In-hospital mortalitySurgical induction to hospital discharge or 30 days postoperative, whichever comes firstIn hospital mortality

Countries

Canada

Outcome results

None listed

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