Coronary Artery Disease, Aortic Valve Stenosis, Mitral Disease
Conditions
Keywords
extracorporeal circulation, Minimal Invasive Extracorporeal Circulation, cardiopulmonary bypass, cerebral oximetry, microcirculation, near-infrared spectroscopy
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: 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
Interventions
DEVICECerebral oximetry
Cerebral oximetry monitoring with near-infrared spectroscopy.
DEVICEPeripheral oximetry
Tissue perfusion monitoring with somatic near-infrared spectroscopy.
DEVICECerebral autoregulation
Cerebral autoregulation monitoring with COx.
DEVICESublingual microscopy
Evaluation of microcirculation with sublingual microscopy.
Sponsors
Aristotle University Of Thessaloniki
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Caregiver)
Intervention model description
All eligible patients will be randomized with computer-generated algorithm to receive cardiac surgery with minimal invasive versus conventional extracorporeal circulation.
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of perfused vessels assessed with sublingual microscopy | During surgery, from induction of anesthesia to weaning of extracorporeal circulation | Proportion of perfused vessels (PPV) assessed with sublingual microscopy. |
| Total vessel density assessed with sublingual microscopy | During surgery, from induction of anesthesia to weaning of extracorporeal circulation | Total vessel density (TVD) assessed with sublingual microscopy. |
| Perfused vessel density assessed with sublingual microscopy | During surgery, from induction of anesthesia to weaning of extracorporeal circulation | Perfused vessel density (PVD) assessed with sublingual microscopy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cerebral oximetry | During surgery, from induction of anesthesia to weaning of extracorporeal circulation | Change in cerebral oxygen saturation during cardiac surgery assessed with near-infrared spectroscopy |
| Peripheral tissue oximetry | During surgery, from induction of anesthesia to weaning of extracorporeal circulation | Change in tissue perfusion during cardiac surgery assessed with near-infrared spectroscopy |
| Cox index assessed with near-infrared spectroscopy | During surgery, from induction of anesthesia to weaning of extracorporeal circulation | Evaluation of cerebral autoregulation during cardiac surgery with continuous monitoring of Cox index (ICM+ software, Cambridge, UK). |
Countries
Greece
Outcome results
None listed