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The aim of the present study is to investigate the protective effect of minimal invasive versus the conventional extracorporeal circulation on tissue homeostasis as evidenced by the preservation of tissue metabolism and cerebral perfusion.
The aim of the present study is to investigate the protective effect of minimal invasive versus the conventional extracorporeal circulation on tissue homeostasis as evidenced by the preservation of tissue metabolism and cerebral perfusion. Seventy patients undergoing coronary artery bypass grafting, aortic valve replacement or both procedures will be included in the study. Patients will be randomized in two groups: patients operated with the contemporary minimal invasive extracorporeal circulation (study group) versus patients operated with conventional extracorporeal circulation (control group). All patients will be operated according to the same anesthetic and perfusion protocol. During extracorporeal circulation, the following parameters will be recorded:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Minimal Invasive Extracorporeal Circulation (MiECC) | Experimental | Patients undergoing cardiac surgery with Minimal Invasive Extracorporeal Circulation |
|
| Conventional Cardiopulmonary Bypass (cCPB) | Active Comparator | Patients undergoing cardiac surgery with conventional cardiopulmonary bypass |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Real-time tissue oximetry monitoring | Device | Real-time tissue metabolism as indicated by oxygen delivery (DO2), oxygen consumption (VO2), oxygen extraction ratio (O2ER), CO2 consumption (VCO2), arterial and mixed venous saturation (SvO2) |
| Measure | Description | Time Frame |
|---|---|---|
| Tissue hypoperfusion severity | Area under the curve (AUC) where tissue oxygen delivery indexed (DO2i) remains below the critical value of 280 ml/min/m2. | During surgery, from initiation of cardiopulmonary bypass to weaning of cardiopulmonary bypass |
| Measure | Description | Time Frame |
|---|---|---|
| Perfusion ratio derangement | Incidence of patients that experience perfusion ratio (DO2i/VCO2i) < 5 during extracorporeal circulation. | During surgery from initiation of extracorporeal circulation to weaning of extracorporeal circulation. |
| Cerebral hypoperfusion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kyriakos Anastasiadis, MD, PhD, FETCS | Aristotle University Of Thessaloniki | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiothoracic Department, Artistotle University of Thessaloniki School of Medicine | Thessaloniki | Greece |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34137323 | Background | Anastasiadis K, Antonitsis P, Asteriou C, Deliopoulos A, Argiriadou H. Modular minimally invasive extracorporeal circulation ensures perfusion safety and technical feasibility in cardiac surgery; a systematic review of the literature. Perfusion. 2022 Nov;37(8):852-862. doi: 10.1177/02676591211026514. Epub 2021 Jun 17. | |
| 34148398 |
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All eligible patients will be randomized with computer-generated algorithm to receive cardiac surgery with minimal invasive versus conventional extracorporeal circulation.
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Incidence of patients that experience a reduction in cerebral near-infrared spectroscopy exceeding -20% from baseline during extracorporeal circulation. |
| During surgery, from initiation to weaning of extracorporeal circulation |
| Overall mortality | Death from any cause | From surgery to 30 days postoperatively |
| Major adverse cardiac and cerebrovascular events | Composite incidense od postoperative stroke, myocardial infarction and need fr revascularization. | From surgery to 30 days postoperatively |
| Renal failure | Incidence of postoperative renal failure | From surgery to 30 days postoperatively |
| Re-intubation | Incidence of re-intubation | From surgery to 30 days postoperatively |
| Re-operation | Incidence of re-operation | From surgery to 30 days postoperatively |
| Postoperative bleeding | Volume of postoperative blood loss | From surgery to 12 hours postoperatively |
| Transfusion | Any blood product transfused | Perioperatively |
| ICU stay | Length of ICU stay | From day of surgery to discharge from ICU, assessed up to 4 weeks postoperatively. |
| Hospital stay | Length of hospital stay | From day of surgery to discharge from hospital, assessed up to 4 weeks postoperatively. |
| Anastasiadis K, Antonitsis P, Deliopoulos A, Argiriadou H. Perfusion matters, and it will always matter in cardiac surgery. Perfusion. 2021 Oct;36(7):677-678. doi: 10.1177/02676591211025154. Epub 2021 Jun 19. No abstract available. |
| 38832503 | Background | Angelini GD, Reeves BC, Culliford LA, Maishman R, Rogers CA, Anastasiadis K, Antonitsis P, Argiriadou H, Carrel T, Keller D, Liebold A, Ashkaniani F, El-Essawi A, Breitenbach I, Lloyd C, Bennett M, Cale A, Gunaydin S, Gunertem E, Oueida F, Yassin IM, Serrick C, Murkin JM, Rao V, Moscarelli M, Condello I, Punjabi P, Rajakaruna C, Deliopoulos A, Bone D, Lansdown W, Moorjani N, Dennis S. Conventional versus minimally invasive extra-corporeal circulation in patients undergoing cardiac surgery: A randomized controlled trial (COMICS). Perfusion. 2025 Apr;40(3):730-741. doi: 10.1177/02676591241258054. Epub 2024 Jun 4. |
| 40338150 | Background | Antonitsis P, Argiriadou H, Gkiouliava A, Deliopoulos A, Mimikos S, Gilou S, Sarridou D, Voucharas C, Karapanagiotidis G, Anastasiadis K. The value of cerebral and somatic near-infrared spectroscopy within an integrated tissue perfusion monitoring strategy in cardiac surgery: A prospective pilot study. Perfusion. 2026 Jan;41(1):69-79. doi: 10.1177/02676591251340942. Epub 2025 May 8. |