Skip to main content
Clinical Trials/NCT05479188
NCT05479188
Completed
Not Applicable

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

Aristotle University Of Thessaloniki1 site in 1 country60 target enrollmentDecember 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Coronary Artery Disease
Sponsor
Aristotle University Of Thessaloniki
Enrollment
60
Locations
1
Primary Endpoint
Perfused vessel density assessed with sublingual microscopy
Status
Completed
Last Updated
last year

Overview

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

Registry
clinicaltrials.gov
Start Date
December 1, 2021
End Date
December 31, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Kyriakos Anastasiadis

Professor of Cardiac Surgery, Head of Cardiothoracic Department

Aristotle University Of Thessaloniki

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

Outcomes

Primary Outcomes

Perfused vessel density assessed with sublingual microscopy

Time Frame: 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

Time Frame: 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

Time Frame: During surgery, from induction of anesthesia to weaning of extracorporeal circulation

Proportion of perfused vessels (PPV) assessed with sublingual microscopy.

Secondary Outcomes

  • Peripheral tissue oximetry(During surgery, from induction of anesthesia to weaning of extracorporeal circulation)
  • Cox index assessed with near-infrared spectroscopy(During surgery, from induction of anesthesia to weaning of extracorporeal circulation)
  • Cerebral oximetry(During surgery, from induction of anesthesia to weaning of extracorporeal circulation)

Study Sites (1)

Loading locations...

Similar Trials