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

Sponsor
Medical University of Vienna (Other)
Overall Status
Completed
CT.gov ID
NCT03732651
Collaborator
(none)
32
Enrollment
1
Location
2
Arms
65.7
Actual Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: alteration of PaCO2 level
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
32 participants
Allocation:
Non-Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
Each patient served as his own control.Each patient served as his own control.
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Basic Science
Official Title:
The Impact of Non-pulsatile Perfusion on Cerebral Blood Flow and Brain Oxygenation
Actual Study Start Date :
Jun 11, 2008
Actual Primary Completion Date :
Oct 11, 2012
Actual Study Completion Date :
Dec 2, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: non-pulsatile blood flow

Procedure: alteration of PaCO2 level
step changes between 30, 40 and 50 mmHg
Experimental: pulsatile blood flow

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

Outcome Measures

Primary Outcome Measures

  1. CO2- Reactivity of cerebral vessels during cardiopulmonary bypass using nonpulsatile blood flow and postoperative on ICU under physiological pulsatile blood flow [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]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
15 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 medical University of Vienna Vienna Austria 1090

Sponsors and Collaborators

  • Medical University of Vienna

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Cecilia Veraar, Cecilia Veraar, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT03732651
Other Study ID Numbers:
  • 1018730
First Posted:
Nov 6, 2018
Last Update Posted:
Nov 6, 2018
Last Verified:
Nov 1, 2018
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Nov 6, 2018