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

NCT03732651 | Completed

• 1 other identifier: 1018730
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebrovascular Circulation

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

non-pulsatile blood flow

EXPERIMENTAL

Procedure: alteration of PaCO2 level

pulsatile blood flow

EXPERIMENTAL

Procedure: alteration of PaCO2 level

Interventions

alteration of PaCO2 level PROCEDURE

step changes between 30, 40 and 50 mmHg

non-pulsatile blood flow; pulsatile blood flow

Eligibility Criteria

• Age: 15 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• undergoing elective cardiac surgery with cardiopulmonary bypass

You may not qualify if:

• Carotid artery stenosis (\> 50%)
• Neurological pathologies
• COPD with CO2 retention
• Women of childbearing age

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

medical University of Vienna

Vienna, 1090, Austria

Location

Related Publications (1)

• Veraar CM, Rinosl H, Kuhn K, Skhirtladze-Dworschak K, Felli A, Mouhieddine M, Menger J, Pataraia E, Ankersmit HJ, Dworschak M. Non-pulsatile blood flow is associated with enhanced cerebrovascular carbon dioxide reactivity and an attenuated relationship between cerebral blood flow and regional brain oxygenation. Crit Care. 2019 Dec 30;23(1):426. doi: 10.1186/s13054-019-2671-7.

  PMID: 31888721 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cecilia Veraar

Model Details: Each patient served as his own control.

Study Record Dates

• First Submitted: October 30, 2018
• First Posted: November 6, 2018
• Study Start: June 11, 2008
• Primary Completion: October 11, 2012
• Study Completion: December 2, 2013
• Last Updated: November 6, 2018

Record last verified: 2018-11

Locations

AU (1)