The Impact of Non-pulsatile Blood Flow on CO2-Reactivity

Cerebrovascular Circulation Clinical Trial

Official title:

The Impact of Non-pulsatile Perfusion on Cerebral Blood Flow and Brain Oxygenation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03732651
• Other study ID #: 1018730
• Status: Completed
• Phase: N/A
• Start date: June 11, 2008
• Est. completion date: December 2, 2013

Study information

• Verified date: November 2018
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators hypothezised that CO2-reactivity of cerebral vessels is affected by systemic non-pulsatile blood flow. Patients undergoing elective cardiac surgery with CPB were enrolled in this prospective case control study. Blood flow velocity in the middle cerebral artery as well as regional cerebral oxygenation was determined during step changes of PaCO2 between 30, 40, and 50 mmHg. Measurements were conducted intraoperatively during non-pulsatile as well as postoperatively after admission to the ICU under pulsatile blood flow.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: December 2, 2013
• Est. primary completion date: October 11, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 75 Years

Eligibility

Inclusion Criteria:

• undergoing elective cardiac surgery with cardiopulmonary bypass

Exclusion Criteria:

• Carotid artery stenosis (> 50%)

• Neurological pathologies

• COPD with CO2 retention

• Women of childbearing age

Related Conditions & MeSH terms

• Cerebrovascular Circulation

Intervention

Procedure:
• alteration of PaCO2 level
step changes between 30, 40 and 50 mmHg

Locations

Country	Name	City	State
Austria	medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CO2- Reactivity of cerebral vessels during cardiopulmonary bypass using nonpulsatile blood flow and postoperative on ICU under physiological pulsatile blood flow	Relation between PaCO2 level and cerebral blood flow velocity will be assessed during non-pulsatile and pulsatile blood flow. Measurements will be performed using trancranial doppler to measure flow velocity of the middle cerebral artery. Further, NIRS will be used to measure oxygen saturation of the brain. Measurements will be performed during step changes of PaCO2 (at 30mmHg, 40mmHg and 50mmHg.	first time-point: intraoperative, during cardiopulmonary bypass, duration up to 300minutes. Second time-point: on ICU, postoperatively under pulsatile blood flow, duration of measurement up to 100minutes for each patient