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.

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease; Aortic Valve Stenosis; Mitral Disease
• Intervention / Treatment: Device: Cerebral oximetry; Device: Peripheral oximetry; Device: Cerebral autoregulation; Device: Sublingual microscopy

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:

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

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Thessaloníki, Greece, 54636
    • Recruiting
    • Cardiothoracic Department, AHEPA University Hospital
    • Contact: Kyriakos Anastasiadis, Professor; Phone Number: +30 2310994845; Email: anastasi@auth.gr
    • Contact: Polychronis Antonitsis, Assoc. Prof.; Phone Number: +30 2310 994871; Email: antonits@auth.gr
    • Sub-Investigator: Helena Argiriadou, Assoc. Prof.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Minimal Invasive Extracorporeal Circulation (MiECC); Patients undergoing cardiac surgery with Minimal Invasive Extracorporeal Circulation.	Device: Cerebral oximetry; Cerebral oximetry monitoring with near-infrared spectroscopy.; Device: Peripheral oximetry; Tissue perfusion monitoring with somatic near-infrared spectroscopy.; Device: Cerebral autoregulation; Cerebral autoregulation monitoring with COx.; Device: Sublingual microscopy; Evaluation of microcirculation with sublingual microscopy.
ACTIVE_COMPARATOR: Conventional cardiopulmonary Bypass (cCPB); Patients undergoing cardiac surgery with conventional cardiopulmonary bypass.	Device: Cerebral oximetry; Cerebral oximetry monitoring with near-infrared spectroscopy.; Device: Peripheral oximetry; Tissue perfusion monitoring with somatic near-infrared spectroscopy.; Device: Cerebral autoregulation; Cerebral autoregulation monitoring with COx.; Device: Sublingual microscopy; Evaluation of microcirculation with sublingual microscopy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Aristotle University Of Thessaloniki
• Investigators: Study Director: Kyriakos Anastasiadis, Prof., Aristotle University of Thessaloniki, School of Medicine; Principal Investigator: Helena Argiriadou, Assoc. Prof., Aristotle University of Thessaloniki, School of Medicine

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2021
• Primary Completion (ANTICIPATED): December 31, 2023
• Study Completion (ANTICIPATED): December 31, 2023

Study Registration Dates

• First Submitted: July 22, 2022
• First Submitted That Met QC Criteria: July 26, 2022
• First Posted (ACTUAL): July 29, 2022

Study Record Updates

• Last Update Posted (ACTUAL): February 1, 2023
• Last Update Submitted That Met QC Criteria: January 31, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: microcirculation; cardiopulmonary bypass; near-infrared spectroscopy; extracorporeal circulation; cerebral oximetry; Minimal Invasive Extracorporeal Circulation
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Coronary Disease; Coronary Artery Disease; Aortic Valve Stenosis
• Other Study ID Numbers: AUS_CTS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No