Cerebral Perfusion in Hypothermic Circulatory Arrest

Study Overview
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Brief Summary
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Selective antegrade cerebral perfusion (sACP) during aortic arch surgery in hypothermic circulatory arrest (HCA) is an established method for intraoperative neuroprotection. Although sACP is established as a beneficial method to reduce secondary neurological side effects due to brain-malperfusion, there are several parameters like sACP flow rate, perfusion pressure or temperature of the perfusate, where the optimal values remain unclear. The flow rate of the sACP-perfusate is increased according to center-specific standard-procedures. The optimal sACP flow rate, monitored by near infrared spectroscopy (NIRS), is to be investigated in this single center clinical prospective observational study. 40 Patients are enrolled over an estimated period of 14 months.

Official Title
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Cerebral Perfusion During Cardiac Surgery With Hypothermic Circulatory Arrest

Conditions
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Cerebrovascular Circulation

Intervention / Treatment
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* Diagnostic Test: Measurement of tissue oxygenation index (TOI)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 years or older Elective cardiac surgery with cardiopulmonary bypass Hypothermic circulatory arrest General informed consent signed Exclusion Criteria: - Severe stenotis in cerebral arteries

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Hypothermic circulatory arrest<br>Patients undergoing cardiac surgery with hypothermic circulatory arrest and selective antegrade cerebral perfusion | Diagnostic Test: Measurement of tissue oxygenation index (TOI)<br>* TOI and Vmca measurement during cardiac surgery with hypothermic circulatory arrest<br>* Other names: Measurement of mean blood flow velocity in the middle cerebral artery (Vmca);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TOI | The primary outcome is the tissue oxygenation index (TOI: NIRS value) at sACP flow rates of 6 , 8 and 10 (ml/kg/min) in comparison to the TOI measured awake. | through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vmca | The secondary outcome is the mean blood flow velocity in the middle cerebral artery at sACP the specified flow rates in comparison to the VmMCA during general anesthesia, after anesthesia induction. | through study completion, an average of 1 year | 
| Neurologic accidents | An additional secondary outcome measure are any neurologic accidents during the same hospital stay. | through study completion, an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiopulmonary bypass, Hypothermic circulatory arrest, Aortic arch surgery