Comparative Analysis of the Microcirculation During Cardiac Surgery With Minimal Invasive Versus Conventional Extracorporeal Circulation
- Conditions
- Coronary Artery DiseaseMitral DiseaseAortic Valve Stenosis
- Interventions
- Device: Cerebral oximetryDevice: Peripheral oximetryDevice: Cerebral autoregulationDevice: Sublingual microscopy
- Registration Number
- NCT05479188
- Lead Sponsor
- Aristotle University Of Thessaloniki
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- patients undergoing undergoing open heart surgery with accepted indications under extracorporeal circulation
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Conventional cardiopulmonary Bypass (cCPB) Cerebral autoregulation Patients undergoing cardiac surgery with conventional cardiopulmonary bypass. Minimal Invasive Extracorporeal Circulation (MiECC) Peripheral oximetry Patients undergoing cardiac surgery with Minimal Invasive Extracorporeal Circulation. Conventional cardiopulmonary Bypass (cCPB) Peripheral oximetry Patients undergoing cardiac surgery with conventional cardiopulmonary bypass. Conventional cardiopulmonary Bypass (cCPB) Cerebral oximetry Patients undergoing cardiac surgery with conventional cardiopulmonary bypass. Conventional cardiopulmonary Bypass (cCPB) Sublingual microscopy Patients undergoing cardiac surgery with conventional cardiopulmonary bypass. Minimal Invasive Extracorporeal Circulation (MiECC) Cerebral oximetry Patients undergoing cardiac surgery with Minimal Invasive Extracorporeal Circulation. Minimal Invasive Extracorporeal Circulation (MiECC) Sublingual microscopy Patients undergoing cardiac surgery with Minimal Invasive Extracorporeal Circulation. Minimal Invasive Extracorporeal Circulation (MiECC) Cerebral autoregulation Patients undergoing cardiac surgery with Minimal Invasive Extracorporeal Circulation.
- Primary Outcome Measures
Name Time Method 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.
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.
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.
- Secondary Outcome Measures
Name Time Method 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).
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
Trial Locations
- Locations (1)
Cardiothoracic Department, AHEPA University Hospital
š¬š·ThessalonĆki, Greece