Coronary Artery Disease Clinical Trial
Official title:
Comparative Analysis of the Microcirculation During Cardiac Surgery With Minimal Invasive Versus Conventional Extracorporeal Circulation
The aim of the proposed study is to evaluate microcirculatory alterations in patients undergoing open heart surgery with minimal invasive versus conventional extracorporeal circulation. Positive clinical results evidenced with goal-directed perfusion and cerebral oximetry monitoring could be attributed to preserved microcirculation at tissue level.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | December 31, 2023 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility | Inclusion Criteria: - patients undergoing undergoing open heart surgery with accepted indications under extracorporeal circulation Exclusion Criteria: - patients undergoing emergency surgery - patients in preoperative cardiogenic shock with evidence of tissue malperfusion - patients with severe peripheral vascular disease - patients unable to give informed consent |
Country | Name | City | State |
---|---|---|---|
Greece | Cardiothoracic Department, AHEPA University Hospital | Thessaloníki |
Lead Sponsor | Collaborator |
---|---|
Aristotle University Of Thessaloniki |
Greece,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of perfused vessels assessed with sublingual microscopy | Proportion of perfused vessels (PPV) assessed with sublingual microscopy. | During surgery, from induction of anesthesia to weaning of extracorporeal circulation | |
Primary | Total vessel density assessed with sublingual microscopy | Total vessel density (TVD) assessed with sublingual microscopy. | During surgery, from induction of anesthesia to weaning of extracorporeal circulation | |
Primary | Perfused vessel density assessed with sublingual microscopy | Perfused vessel density (PVD) assessed with sublingual microscopy. | During surgery, from induction of anesthesia to weaning of extracorporeal circulation | |
Secondary | Cerebral oximetry | Change in cerebral oxygen saturation during cardiac surgery assessed with near-infrared spectroscopy | During surgery, from induction of anesthesia to weaning of extracorporeal circulation | |
Secondary | Peripheral tissue oximetry | Change in tissue perfusion during cardiac surgery assessed with near-infrared spectroscopy | During surgery, from induction of anesthesia to weaning of extracorporeal circulation | |
Secondary | Cox index assessed with near-infrared spectroscopy | Evaluation of cerebral autoregulation during cardiac surgery with continuous monitoring of Cox index (ICM+ software, Cambridge, UK). | During surgery, from induction of anesthesia to weaning of extracorporeal circulation |
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