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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05479188
• Other study ID #: AUS_CTS
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: January 2023
• Source: Aristotle University Of Thessaloniki
• Contact: Polychronis Antonitsis, Assoc. Prof.
• Phone: +30 2310994871
• Email: antonits[@]auth.gr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Coronary Artery Disease
• Mitral Disease

Intervention

Device:
• Cerebral oximetry
Cerebral oximetry monitoring with near-infrared spectroscopy.
• Peripheral oximetry
Tissue perfusion monitoring with somatic near-infrared spectroscopy.
• Cerebral autoregulation
Cerebral autoregulation monitoring with COx.
• Sublingual microscopy
Evaluation of microcirculation with sublingual microscopy.

Locations

Country	Name	City	State
Greece	Cardiothoracic Department, AHEPA University Hospital	Thessaloníki

Sponsors (1)

Lead Sponsor	Collaborator
Aristotle University Of Thessaloniki

Country where clinical trial is conducted

Greece, 

References & Publications (5)

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. — View Citation

Donndorf P, Kuhn F, Vollmar B, Rosner J, Liebold A, Gierer P, Steinhoff G, Kaminski A. Comparing microvascular alterations during minimal extracorporeal circulation and conventional cardiopulmonary bypass in coronary artery bypass graft surgery: a prospective, randomized study. J Thorac Cardiovasc Surg. 2012 Sep;144(3):677-83. doi: 10.1016/j.jtcvs.2012.05.037. Epub 2012 Jun 12. — View Citation

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. — View Citation

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. — View Citation

Yuruk K, Bezemer R, Euser M, Milstein DM, de Geus HH, Scholten EW, de Mol BA, Ince C. The effects of conventional extracorporeal circulation versus miniaturized extracorporeal circulation on microcirculation during cardiopulmonary bypass-assisted coronary artery bypass graft surgery. Interact Cardiovasc Thorac Surg. 2012 Sep;15(3):364-70. doi: 10.1093/icvts/ivs271. Epub 2012 Jun 14. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of perfused vessels assessed with sublingual microscopy	Proportion of perfused vessels (PPV) assessed with sublingual microscopy.	During surgery, from induction of anesthesia to weaning of extracorporeal circulation
Primary	Total vessel density assessed with sublingual microscopy	Total vessel density (TVD) assessed with sublingual microscopy.	During surgery, from induction of anesthesia to weaning of extracorporeal circulation
Primary	Perfused vessel density assessed with sublingual microscopy	Perfused vessel density (PVD) assessed with sublingual microscopy.	During surgery, from induction of anesthesia to weaning of extracorporeal circulation
Secondary	Cerebral oximetry	Change in cerebral oxygen saturation during cardiac surgery assessed with near-infrared spectroscopy	During surgery, from induction of anesthesia to weaning of extracorporeal circulation
Secondary	Peripheral tissue oximetry	Change in tissue perfusion during cardiac surgery assessed with near-infrared spectroscopy	During surgery, from induction of anesthesia to weaning of extracorporeal circulation
Secondary	Cox index assessed with near-infrared spectroscopy	Evaluation of cerebral autoregulation during cardiac surgery with continuous monitoring of Cox index (ICM+ software, Cambridge, UK).	During surgery, from induction of anesthesia to weaning of extracorporeal circulation