Study of Microcirculation During Extracorporeal Circulation in Cardiac Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-01

Study Completion Date

2021-11-30

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Heart Diseases

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Patients undergoing open heart surgery with minimal invasive extracorporeal circulation (MiECC) according to accepted indications

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Study Patients

Patients undergoing open heart surgery with minimal invasive extracorporeal circulation (MiECC) according to accepted indications

Group Type OTHER

NIRS monitoring

Intervention Type DEVICE

Cerebral and somatic near-infrared spectroscopy (rScO2) measurements

Cox monitoring

Intervention Type DEVICE

Cerebral autoregulation monitoring

Sublingual microscopy

Intervention Type DEVICE

Sublingual mucosal microcirculation measurements during surgery using side dark field (SDF) imaging

Interventions

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NIRS monitoring

Cerebral and somatic near-infrared spectroscopy (rScO2) measurements

Intervention Type DEVICE

Cox monitoring

Cerebral autoregulation monitoring

Intervention Type DEVICE

Sublingual microscopy

Sublingual mucosal microcirculation measurements during surgery using side dark field (SDF) imaging

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* patients aged \> 18 and \< 85 years with coronary artery disease and/or aortic valve disease undergoing open heart surgery with accepted indications

Exclusion Criteria

* patients undergoing emergency surgery
* patients in preoperative cardiogenic shock with evidence of tissue malperfusion
* patients \> 85 years of age
* patients with severe peripheral vascular disease

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No