Comparative Analysis of the Microcirculation During Cardiac Surgery With Minimal Invasive Versus Conventional Extracorporeal Circulation

Study Overview
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Brief Summary
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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
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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

Official Title
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Comparative Analysis of the Microcirculation During Cardiac Surgery With Minimal Invasive Versus Conventional Extracorporeal Circulation

Conditions
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Coronary Artery Disease, Aortic Valve Stenosis, Mitral Disease

Intervention / Treatment
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* Device: Cerebral oximetry
* Device: Peripheral oximetry
* Device: Cerebral autoregulation
* Device: Sublingual microscopy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: All eligible patients will be randomized with computer-generated algorithm to receive cardiac surgery with minimal invasive versus conventional extracorporeal circulation.
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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extracorporeal circulation, Minimal Invasive Extracorporeal Circulation, cardiopulmonary bypass, cerebral oximetry, microcirculation, near-infrared spectroscopy