Cerebral Perfusion in Hypothermic Circulatory Arrest

Cerebral Perfusion During Cardiac Surgery With Hypothermic Circulatory Arrest

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03484104

Enrollment

Registered

2018-03-30

Start date

2018-07-01

Completion date

2021-09-28

Last updated

2021-09-29

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

Conditions

Cerebrovascular Circulation

Keywords

Cardiopulmonary bypass, Hypothermic circulatory arrest, Aortic arch surgery

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.

Interventions

DIAGNOSTIC_TESTMeasurement of tissue oxygenation index (TOI)

TOI and Vmca measurement during cardiac surgery with hypothermic circulatory arrest

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Switzerland

Outcome results

None listed

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