Comparative Analysis of the Microcirculation During Cardiac Surgery With Minimal Invasive Versus Conventional Extracorporeal Circulation
NCT ID: NCT05479188
Last Updated: 2024-08-07
Study Results
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Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2021-12-01
2023-12-31
Brief Summary
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Detailed Description
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Microcirculatory changes during cardiac surgery have been investigated mainly during coronary procedures using the conventional extracorporeal circulation.There is no single study in the literature investigating microcirculatory alterations using a perioperative strategy of "physiologic" perfusion.
Positive clinical results evidenced with goal-directed perfusion and cerebral oximetry monitoring could be attributed to preserved microcirculation at tissue level.
All patients will follow the same anaesthetic and perfusion protocol. The patients will be randomized to two arms:
1. Patients operated with Minimal Invasive Extracorporeal Circulation (MiECC)
2. Patients operated with conventional cardiopulmonary bypass (cCPB)
The protocol for the evaluation of microcirculation will be based on:
* Cerebral near-infrared spectroscopy (rScO2) measurements (INVOS, Covidien-Medtronic Inc.).
* NIRS-Based Cerebral Autoregulation Monitoring: Analog arterial blood pressure signals will be digitized and then processed with the digital NIRS signals using a personal computer and a special ICM software (University of Cambridge, Cambridge, UK). Monitoring cerebral autoregulation ensures adequate renal perfusion. Hence, brain can be used not just as a target but also as an index organ indicating adequacy of perfusion.
* Somatic near-infrared spectroscopy (rSsO2) measurements (INVOS, Covidien-Medtronic Inc.).
* Sublingual mucosal microcirculation measurements during surgery using side dark field (SDF) imaging (MicroScan, Microvision Medical, Amsterdam, The Netherlands).
All measurements will be performed at the following time points:
T0: after induction of anaesthesia T1: after initiation of cardiopulmonary bypass T2: 10 minutes after cross- clamping the aorta T3: 10 minutes before removing the aortic cross-clamp T4: after weaning from extracorporeal circulation
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
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Minimal Invasive Extracorporeal Circulation (MiECC)
Patients undergoing cardiac surgery with Minimal Invasive Extracorporeal Circulation.
Cerebral oximetry
Cerebral oximetry monitoring with near-infrared spectroscopy.
Peripheral oximetry
Tissue perfusion monitoring with somatic near-infrared spectroscopy.
Cerebral autoregulation
Cerebral autoregulation monitoring with COx.
Sublingual microscopy
Evaluation of microcirculation with sublingual microscopy.
Conventional cardiopulmonary Bypass (cCPB)
Patients undergoing cardiac surgery with conventional cardiopulmonary bypass.
Cerebral oximetry
Cerebral oximetry monitoring with near-infrared spectroscopy.
Peripheral oximetry
Tissue perfusion monitoring with somatic near-infrared spectroscopy.
Cerebral autoregulation
Cerebral autoregulation monitoring with COx.
Sublingual microscopy
Evaluation of microcirculation with sublingual microscopy.
Interventions
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Cerebral oximetry
Cerebral oximetry monitoring with near-infrared spectroscopy.
Peripheral oximetry
Tissue perfusion monitoring with somatic near-infrared spectroscopy.
Cerebral autoregulation
Cerebral autoregulation monitoring with COx.
Sublingual microscopy
Evaluation of microcirculation with sublingual microscopy.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* patients in preoperative cardiogenic shock with evidence of tissue malperfusion
* patients with severe peripheral vascular disease
* patients unable to give informed consent
18 Years
85 Years
ALL
No
Sponsors
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Aristotle University Of Thessaloniki
OTHER
Responsible Party
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Kyriakos Anastasiadis
Professor of Cardiac Surgery, Head of Cardiothoracic Department
Principal Investigators
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Kyriakos Anastasiadis, Prof.
Role: STUDY_DIRECTOR
Aristotle University Of Thessaloniki
Helena Argiriadou, Assoc. Prof.
Role: PRINCIPAL_INVESTIGATOR
Aristotle University Of Thessaloniki
Locations
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Cardiothoracic Department, AHEPA University Hospital
Thessaloniki, , Greece
Countries
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References
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Anastasiadis K, Antonitsis P, Deliopoulos A, Argiriadou H. A multidisciplinary perioperative strategy for attaining "more physiologic" cardiac surgery. Perfusion. 2017 Sep;32(6):446-453. doi: 10.1177/0267659117700488. Epub 2017 Mar 10.
Yuruk K, Bezemer R, Euser M, Milstein DM, de Geus HH, Scholten EW, de Mol BA, Ince C. The effects of conventional extracorporeal circulation versus miniaturized extracorporeal circulation on microcirculation during cardiopulmonary bypass-assisted coronary artery bypass graft surgery. Interact Cardiovasc Thorac Surg. 2012 Sep;15(3):364-70. doi: 10.1093/icvts/ivs271. Epub 2012 Jun 14.
Donndorf P, Kuhn F, Vollmar B, Rosner J, Liebold A, Gierer P, Steinhoff G, Kaminski A. Comparing microvascular alterations during minimal extracorporeal circulation and conventional cardiopulmonary bypass in coronary artery bypass graft surgery: a prospective, randomized study. J Thorac Cardiovasc Surg. 2012 Sep;144(3):677-83. doi: 10.1016/j.jtcvs.2012.05.037. Epub 2012 Jun 12.
Koning NJ, Vonk AB, Meesters MI, Oomens T, Verkaik M, Jansen EK, Baufreton C, Boer C. Microcirculatory perfusion is preserved during off-pump but not on-pump cardiac surgery. J Cardiothorac Vasc Anesth. 2014 Apr;28(2):336-41. doi: 10.1053/j.jvca.2013.05.026. Epub 2013 Oct 23.
Kara A, Akin S, Ince C. The response of the microcirculation to cardiac surgery. Curr Opin Anaesthesiol. 2016 Feb;29(1):85-93. doi: 10.1097/ACO.0000000000000280.
Other Identifiers
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AUS_CTS
Identifier Type: -
Identifier Source: org_study_id
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