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

• Sponsor: Aristotle University Of Thessaloniki (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05479188
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 13
• Patients Per Site Per Month: 4.6

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease; Aortic Valve Stenosis; Mitral Disease	Device: Cerebral oximetry; Device: Peripheral oximetry; Device: Cerebral autoregulation; Device: Sublingual microscopy	N/A

Detailed 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

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: All eligible patients will be randomized with computer-generated algorithm to receive cardiac surgery with minimal invasive versus conventional extracorporeal circulation.All eligible patients will be randomized with computer-generated algorithm to receive cardiac surgery with minimal invasive versus conventional extracorporeal circulation.
• Masking: Single (Care Provider)
• Primary Purpose: Diagnostic
• Official Title: Comparative Analysis of the Microcirculation During Cardiac Surgery With Minimal Invasive Versus Conventional Extracorporeal Circulation
• Actual Study Start Date: Dec 1, 2021
• Anticipated Primary Completion Date: Dec 31, 2022
• Anticipated Study Completion Date: Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Minimal Invasive Extracorporeal Circulation (MiECC) Patients undergoing cardiac surgery with Minimal Invasive Extracorporeal Circulation.	Device: Cerebral oximetry; Cerebral oximetry monitoring with near-infrared spectroscopy.; Device: Peripheral oximetry; Tissue perfusion monitoring with somatic near-infrared spectroscopy.; Device: Cerebral autoregulation; Cerebral autoregulation monitoring with COx.; Device: Sublingual microscopy; Evaluation of microcirculation with sublingual microscopy.
Active Comparator: Conventional cardiopulmonary Bypass (cCPB) Patients undergoing cardiac surgery with conventional cardiopulmonary bypass.	Device: Cerebral oximetry; Cerebral oximetry monitoring with near-infrared spectroscopy.; Device: Peripheral oximetry; Tissue perfusion monitoring with somatic near-infrared spectroscopy.; Device: Cerebral autoregulation; Cerebral autoregulation monitoring with COx.; Device: Sublingual microscopy; Evaluation of microcirculation with sublingual microscopy.

Outcome Measures

Primary Outcome Measures

1. Proportion of perfused vessels assessed with sublingual microscopy [During surgery, from induction of anesthesia to weaning of extracorporeal circulation]

   Proportion of perfused vessels (PPV) assessed with sublingual microscopy.

2. Total vessel density assessed with sublingual microscopy [During surgery, from induction of anesthesia to weaning of extracorporeal circulation]

   Total vessel density (TVD) assessed with sublingual microscopy.

3. Perfused vessel density assessed with sublingual microscopy [During surgery, from induction of anesthesia to weaning of extracorporeal circulation]

   Perfused vessel density (PVD) assessed with sublingual microscopy.

Secondary Outcome Measures

1. Cerebral oximetry [During surgery, from induction of anesthesia to weaning of extracorporeal circulation]

   Change in cerebral oxygen saturation during cardiac surgery assessed with near-infrared spectroscopy

2. Peripheral tissue oximetry [During surgery, from induction of anesthesia to weaning of extracorporeal circulation]

   Change in tissue perfusion during cardiac surgery assessed with near-infrared spectroscopy

3. Cox index assessed with near-infrared spectroscopy [During surgery, from induction of anesthesia to weaning of extracorporeal circulation]

   Evaluation of cerebral autoregulation during cardiac surgery with continuous monitoring of Cox index (ICM+ software, Cambridge, UK).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cardiothoracic Department, AHEPA University Hospital	Thessaloníki		Greece	54636

Sponsors and Collaborators

• Aristotle University Of Thessaloniki

Investigators

• Study Director: Kyriakos Anastasiadis, Prof., Aristotle University Of Thessaloniki, School of Medicine
• Principal Investigator: Helena Argiriadou, Assoc. Prof., Aristotle University Of Thessaloniki, School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• Donndorf P, Kühn F, Vollmar B, Rösner 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.
• 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. Review.
• 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.
• 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.

• Responsible Party: Kyriakos Anastasiadis, Professor of Cardiac Surgery, Head of Cardiothoracic Department, Aristotle University Of Thessaloniki
• ClinicalTrials.gov Identifier: NCT05479188
• Other Study ID Numbers: AUS_CTS
• First Posted: Jul 29, 2022
• Last Update Posted: Aug 10, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Kyriakos Anastasiadis, Professor of Cardiac Surgery, Head of Cardiothoracic Department, Aristotle University Of Thessaloniki: extracorporeal circulation; Minimal Invasive Extracorporeal Circulation; cardiopulmonary bypass; cerebral oximetry; microcirculation; near-infrared spectroscopy
• Additional relevant MeSH terms: Coronary Artery Disease; Aortic Valve Stenosis

Study Results

No Results Posted as of Aug 10, 2022