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

Aristotle University Of Thessaloniki

Status: Completed

Conditions: Coronary Artery Disease; Aortic Valve Stenosis; Mitral Disease

Treatments: Device: Cerebral autoregulation; Device: Cerebral oximetry; Device: Peripheral oximetry; Device: Sublingual microscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT05479188

AUS_CTS

Details and patient eligibility

About

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.

Full 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

Enrollment: 60 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Minimal Invasive Extracorporeal Circulation (MiECC)

Active Comparator group

Description:

Patients undergoing cardiac surgery with Minimal Invasive Extracorporeal Circulation.

Treatment:

Device: Sublingual microscopy

Device: Peripheral oximetry

Device: Cerebral oximetry

Device: Cerebral autoregulation

Conventional cardiopulmonary Bypass (cCPB)

Active Comparator group

Description:

Patients undergoing cardiac surgery with conventional cardiopulmonary bypass.

Treatment:

Device: Sublingual microscopy

Device: Peripheral oximetry

Device: Cerebral oximetry

Device: Cerebral autoregulation