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

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ClinicalTrials.gov Identifier: NCT03732651
Recruitment Status : Completed
First Posted : November 6, 2018
Last Update Posted : November 6, 2018
Sponsor:
Information provided by (Responsible Party):
Cecilia Veraar, Medical University of Vienna

Study Description
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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
Cerebrovascular Circulation Procedure: alteration of PaCO2 level Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: 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 : June 11, 2008
Actual Primary Completion Date : October 11, 2012
Actual Study Completion Date : December 2, 2013
Arms and Interventions
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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
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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 [ Time Frame: 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
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Ages Eligible for Study:   15 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03732651


Locations
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Austria
medical University of Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Cecilia Veraar, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT03732651    
Other Study ID Numbers: 1018730
First Posted: November 6, 2018    Key Record Dates
Last Update Posted: November 6, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No