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

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.

Study Overview

• Status: Completed
• Conditions: Heart Diseases
• Intervention / Treatment: Device: NIRS monitoring; Device: Cox monitoring; Device: Sublingual microscopy

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

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Thessaloniki, Greece
    • Cardiothoracic Department, AHEPA University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 83 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Study Patients; Patients undergoing open heart surgery with minimal invasive extracorporeal circulation (MiECC) according to accepted indications	Device: NIRS monitoring; Cerebral and somatic near-infrared spectroscopy (rScO2) measurements; Device: Cox monitoring; Cerebral autoregulation monitoring; Device: Sublingual microscopy; Sublingual mucosal microcirculation measurements during surgery using side dark field (SDF) imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of microcirculation	Correlation of NIRS values with tissue microvascular activity	During surgery, from induction of anesthesia to weaning of extracorporeal circulation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Global perfusion	Global perfusion using cerebral NIRS during extracorporeal circulation	During surgery, from induction of anesthesia to weaning of extracorporeal circulation
Cerebral autoregulation	Calculation of cerebral oximetry index (COx)	During surgery, from induction of anesthesia to weaning of extracorporeal circulation
Goal-directed perfusion	Correlation of goal-directed perfusion with microvascular capillary density during extracorporeal circulation	During surgery, from induction of anesthesia to weaning of extracorporeal circulation
Somatic perfusion	Peripheral tissue oxygenation as measured with somatic NIRS	During surgery, from induction of anesthesia to weaning of extracorporeal circulation

Collaborators and Investigators

• Sponsor: AHEPA University Hospital
• Collaborators: Medtronic - MITG
• Investigators: Principal Investigator: Kyriakos Anastasiadis, MD, PhD, Cardiothoracic Department, AHEPA University Hospital, Thessaloniki, Greece; Principal Investigator: Helena Argiriadou, MD, PhD, Cardiothoracic Department, AHEPA University Hospital, Thessaloniki, Greece

Publications and helpful links

General Publications

• Murkin JM. Cerebral oximetry: monitoring the brain as the index organ. Anesthesiology. 2011 Jan;114(1):12-3. doi: 10.1097/ALN.0b013e3181fef5d2. No abstract available.
• Anastasiadis K, Antonitsis P, Deliopoulos A, Argiriadou H. A multidisciplinary perioperative strategy for attaining "more physiologic" cardiac surgery. Perfusion. 2017 Sep;32(6):446-453. doi: 10.1177/0267659117700488. Epub 2017 Mar 10.
• Anastasiadis K, Antonitsis P, Ranucci M, Murkin J. Minimally Invasive Extracorporeal Circulation (MiECC): Towards a More Physiologic Perfusion. J Cardiothorac Vasc Anesth. 2016 Apr;30(2):280-1. doi: 10.1053/j.jvca.2016.01.018. Epub 2016 Jan 13. No abstract available.
• Murphy GS, Hessel EA 2nd, Groom RC. Optimal perfusion during cardiopulmonary bypass: an evidence-based approach. Anesth Analg. 2009 May;108(5):1394-417. doi: 10.1213/ane.0b013e3181875e2e.
• Koning NJ, Vonk AB, Meesters MI, Oomens T, Verkaik M, Jansen EK, Baufreton C, Boer C. Microcirculatory perfusion is preserved during off-pump but not on-pump cardiac surgery. J Cardiothorac Vasc Anesth. 2014 Apr;28(2):336-41. doi: 10.1053/j.jvca.2013.05.026. Epub 2013 Oct 23.
• Kara A, Akin S, Ince C. The response of the microcirculation to cardiac surgery. Curr Opin Anaesthesiol. 2016 Feb;29(1):85-93. doi: 10.1097/ACO.0000000000000280.
• den Uil CA, Lagrand WK, Spronk PE, van Domburg RT, Hofland J, Luthen C, Brugts JJ, van der Ent M, Simoons ML. Impaired sublingual microvascular perfusion during surgery with cardiopulmonary bypass: a pilot study. J Thorac Cardiovasc Surg. 2008 Jul;136(1):129-34. doi: 10.1016/j.jtcvs.2007.10.046. Epub 2008 May 2.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2020
• Primary Completion (Actual): November 30, 2021
• Study Completion (Actual): November 30, 2021

Study Registration Dates

• First Submitted: August 12, 2019
• First Submitted That Met QC Criteria: August 13, 2019
• First Posted (Actual): August 16, 2019

Study Record Updates

• Last Update Posted (Actual): July 25, 2022
• Last Update Submitted That Met QC Criteria: July 22, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Cardiac Surgery; Microcirculation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases
• Other Study ID Numbers: AHEPA_CTS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No