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Study of Microcirculation During Extracorporeal Circulation in Cardiac Surgery

Study of Microcirculation During Extracorporeal Circulation in Cardiac Surgery; Challenging Near-infrared Spectroscopy With Microvascular Density and Metabolic Parameters

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04058860
Enrollment
30
Registered
2019-08-16
Start date
2020-06-01
Completion date
2021-11-30
Last updated
2022-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Diseases

Keywords

Microcirculation, Cardiac Surgery

Brief 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

Interventions

Cerebral and somatic near-infrared spectroscopy (rScO2) measurements

DEVICECox monitoring

Cerebral autoregulation monitoring

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

Sponsors

Medtronic - MITG
CollaboratorINDUSTRY
AHEPA University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Evaluation of microcirculationDuring surgery, from induction of anesthesia to weaning of extracorporeal circulationCorrelation of NIRS values with tissue microvascular activity

Secondary

MeasureTime frameDescription
Global perfusionDuring surgery, from induction of anesthesia to weaning of extracorporeal circulationGlobal perfusion using cerebral NIRS during extracorporeal circulation
Cerebral autoregulationDuring surgery, from induction of anesthesia to weaning of extracorporeal circulationCalculation of cerebral oximetry index (COx)
Goal-directed perfusionDuring surgery, from induction of anesthesia to weaning of extracorporeal circulationCorrelation of goal-directed perfusion with microvascular capillary density during extracorporeal circulation
Somatic perfusionDuring surgery, from induction of anesthesia to weaning of extracorporeal circulationPeripheral tissue oxygenation as measured with somatic NIRS

Countries

Greece

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026