Comparative Analysis of the Microcirculation During Cardiac Surgery With Minimal Invasive Versus Conventional Extracorporeal Circulation
Primary Purpose
Coronary Artery Disease, Aortic Valve Stenosis, Mitral Disease
Status
Recruiting
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Cerebral oximetry
Peripheral oximetry
Cerebral autoregulation
Sublingual microscopy
Sponsored by
About this trial
This is an interventional diagnostic trial for Coronary Artery Disease focused on measuring extracorporeal circulation, Minimal Invasive Extracorporeal Circulation, cardiopulmonary bypass, cerebral oximetry, microcirculation, near-infrared spectroscopy
Eligibility Criteria
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
Sites / Locations
- Cardiothoracic Department, AHEPA University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Minimal Invasive Extracorporeal Circulation (MiECC)
Conventional cardiopulmonary Bypass (cCPB)
Arm Description
Patients undergoing cardiac surgery with Minimal Invasive Extracorporeal Circulation.
Patients undergoing cardiac surgery with conventional cardiopulmonary bypass.
Outcomes
Primary Outcome Measures
Proportion of perfused vessels assessed with sublingual microscopy
Proportion of perfused vessels (PPV) assessed with sublingual microscopy.
Total vessel density assessed with sublingual microscopy
Total vessel density (TVD) assessed with sublingual microscopy.
Perfused vessel density assessed with sublingual microscopy
Perfused vessel density (PVD) assessed with sublingual microscopy.
Secondary Outcome Measures
Cerebral oximetry
Change in cerebral oxygen saturation during cardiac surgery assessed with near-infrared spectroscopy
Peripheral tissue oximetry
Change in tissue perfusion during cardiac surgery assessed with near-infrared spectroscopy
Cox index assessed with near-infrared spectroscopy
Evaluation of cerebral autoregulation during cardiac surgery with continuous monitoring of Cox index (ICM+ software, Cambridge, UK).
Full Information
NCT ID
NCT05479188
First Posted
July 22, 2022
Last Updated
January 31, 2023
Sponsor
Aristotle University Of Thessaloniki
1. Study Identification
Unique Protocol Identification Number
NCT05479188
Brief Title
Comparative Analysis of the Microcirculation During Cardiac Surgery With Minimal Invasive Versus Conventional Extracorporeal Circulation
Official Title
Comparative Analysis of the Microcirculation During Cardiac Surgery With Minimal Invasive Versus Conventional Extracorporeal Circulation
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aristotle University Of Thessaloniki
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
The aim of the proposed study is to evaluate microcirculatory alterations in patients undergoing open heart surgery with minimal invasive versus conventional extracorporeal circulation.
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:
Patients operated with Minimal Invasive Extracorporeal Circulation (MiECC)
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Aortic Valve Stenosis, Mitral Disease
Keywords
extracorporeal circulation, Minimal Invasive Extracorporeal Circulation, cardiopulmonary bypass, cerebral oximetry, microcirculation, near-infrared spectroscopy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
All eligible patients will be randomized with computer-generated algorithm to receive cardiac surgery with minimal invasive versus conventional extracorporeal circulation.
Masking
Care Provider
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Minimal Invasive Extracorporeal Circulation (MiECC)
Arm Type
Active Comparator
Arm Description
Patients undergoing cardiac surgery with Minimal Invasive Extracorporeal Circulation.
Arm Title
Conventional cardiopulmonary Bypass (cCPB)
Arm Type
Active Comparator
Arm Description
Patients undergoing cardiac surgery with conventional cardiopulmonary bypass.
Intervention Type
Device
Intervention Name(s)
Cerebral oximetry
Intervention Description
Cerebral oximetry monitoring with near-infrared spectroscopy.
Intervention Type
Device
Intervention Name(s)
Peripheral oximetry
Intervention Description
Tissue perfusion monitoring with somatic near-infrared spectroscopy.
Intervention Type
Device
Intervention Name(s)
Cerebral autoregulation
Intervention Description
Cerebral autoregulation monitoring with COx.
Intervention Type
Device
Intervention Name(s)
Sublingual microscopy
Intervention Description
Evaluation of microcirculation with sublingual microscopy.
Primary Outcome Measure Information:
Title
Proportion of perfused vessels assessed with sublingual microscopy
Description
Proportion of perfused vessels (PPV) assessed with sublingual microscopy.
Time Frame
During surgery, from induction of anesthesia to weaning of extracorporeal circulation
Title
Total vessel density assessed with sublingual microscopy
Description
Total vessel density (TVD) assessed with sublingual microscopy.
Time Frame
During surgery, from induction of anesthesia to weaning of extracorporeal circulation
Title
Perfused vessel density assessed with sublingual microscopy
Description
Perfused vessel density (PVD) assessed with sublingual microscopy.
Time Frame
During surgery, from induction of anesthesia to weaning of extracorporeal circulation
Secondary Outcome Measure Information:
Title
Cerebral oximetry
Description
Change in cerebral oxygen saturation during cardiac surgery assessed with near-infrared spectroscopy
Time Frame
During surgery, from induction of anesthesia to weaning of extracorporeal circulation
Title
Peripheral tissue oximetry
Description
Change in tissue perfusion during cardiac surgery assessed with near-infrared spectroscopy
Time Frame
During surgery, from induction of anesthesia to weaning of extracorporeal circulation
Title
Cox index assessed with near-infrared spectroscopy
Description
Evaluation of cerebral autoregulation during cardiac surgery with continuous monitoring of Cox index (ICM+ software, Cambridge, UK).
Time Frame
During surgery, from induction of anesthesia to weaning of extracorporeal circulation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Polychronis Antonitsis, Assoc. Prof.
Phone
+30 2310994871
Email
antonits@auth.gr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyriakos Anastasiadis, Prof.
Organizational Affiliation
Aristotle University Of Thessaloniki, School of Medicine
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Helena Argiriadou, Assoc. Prof.
Organizational Affiliation
Aristotle University Of Thessaloniki, School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cardiothoracic Department, AHEPA University Hospital
City
Thessaloníki
ZIP/Postal Code
54636
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kyriakos Anastasiadis, Professor
Phone
+30 2310994845
Email
anastasi@auth.gr
First Name & Middle Initial & Last Name & Degree
Polychronis Antonitsis, Assoc. Prof.
Phone
+30 2310 994871
Email
antonits@auth.gr
First Name & Middle Initial & Last Name & Degree
Helena Argiriadou, Assoc. Prof.
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28692337
Citation
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.
Results Reference
background
PubMed Identifier
22700685
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.
Results Reference
background
PubMed Identifier
22698563
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.
Results Reference
background
PubMed Identifier
24161555
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.
Results Reference
background
PubMed Identifier
26658179
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.
Results Reference
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Comparative Analysis of the Microcirculation During Cardiac Surgery With Minimal Invasive Versus Conventional Extracorporeal Circulation
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