Cerebral Perfusion in Hypothermic Circulatory Arrest

Completed

• Conditions: Cerebrovascular Circulation
• Interventions: Diagnostic Test: Measurement of tissue oxygenation index (TOI)

• Registration Number: NCT03484104
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-03-16
• Study First Submitted QC: 2018-03-29
• Study First Posted: 2018-03-30
• Study Start: 2018-07-01
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-27
• Primary Completion: 2021-09-28
• Study Completion: 2021-09-28
• Last Update Posted: 2021-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hypothermic circulatory arrest	Measurement of tissue oxygenation index (TOI)	Patients undergoing cardiac surgery with hypothermic circulatory arrest and selective antegrade cerebral perfusion

Primary Outcome Measures

Name	Time	Method
TOI	through study completion, an average of 1 year	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.

Secondary Outcome Measures

Name	Time	Method
Vmca	through study completion, an average of 1 year	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.
Neurologic accidents	through study completion, an average of 1 year	An additional secondary outcome measure are any neurologic accidents during the same hospital stay.

Trial Locations

Locations (2)

Inselspital, University Hospital Bern, University of Bern; 🇨🇭 Bern, Switzerland

University of Bern; 🇨🇭 Bern, Switzerland