Study of Microcirculation During Extracorporeal Circulation in Cardiac Surgery
Condition: Heart Diseases
MeSH terms: Heart Diseases
Study type: Interventional

Summary: 
      The aim of the proposed study is to evaluate microcirculatory alterations in patients
      undergoing open heart surgery under 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 under 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 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
    

Intervention name(s): NIRS monitoring; Cox monitoring; Sublingual microscopy
Intervention type(s): Device; Device; Device
Intervention description(s): Cerebral and somatic near-infrared spectroscopy (rScO2) measurements; Cerebral autoregulation monitoring; Sublingual mucosal microcirculation measurements during surgery using side dark field (SDF) imaging
Intervention model: Single Group Assignment
Intervention model description: Patients undergoing open heart surgery with minimal invasive extracorporeal circulation (MiECC) according to accepted indications
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Microcirculation; Cardiac Surgery