a Randomized Clinical Trial Evaluating the Effectiveness of Carbon Dioxide Use in Cardiac Surgery (CAR-DRIVER)

Pilot Prospective Randomized Clinical Trial "Insufflation of Carbon Dioxide During Minimally Invasive and Repeated Cardiac Surgery"

study of the efficacy and safety of carbon dioxide in cardiac surgery: repeated or minimally invasive

Study Overview

• Status: Unknown
• Conditions: Carbon Dioxide
• Intervention / Treatment: Procedure: carbon dioxide insufflation; Procedure: No carbon dioxide insufflation

Detailed Description

prospective randomized clinical single-center study of the efficacy and safety of using carbon dioxide in deaeration of cardiac cavities during cardiac surgery (repeated interventions and minimally invasive interventions)

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russian Federation
  • Novosibirsk, Russian Federation
    • Recruiting
    • "E.Meshalkin National medical research center" of the Ministry of Health of the Russian Federation
    • Contact: Alexander V. Bogachev-Prokophiev, MD, PhD; Phone Number: +73833476029; Email: bogachev.prokophiev@gmail.com
    • Contact: Sergei A. Budagaev; Phone Number: +73833476029; Email: ser.bud.med@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Planned cardiac surgery on the left heart with limited deaeration: Minimally invasive approach (mininotomy, minimally invasive lateral thoracotomy); Re-intervention
• Signed informed voluntary consent

Exclusion Criteria:

• Patient refusal to participate in any stage of the study
• History of stroke, transient ischemic attack
• Hemodynamically significant stenosis of the brachiocephalic arteries (more than 70%)
• Swelling or thrombosis of the heart
• LV dysfunction (EF less than 30%)
• Atherosclerosis of the aorta (atheromatosis)
• Surgical access conversion

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: carbon dioxide insufflation; patients with planned minimally invasive or repeated cardiac surgery using standard methods of deaeration of cardiac cavities, supplemented with carbon dioxide insufflation during surgery + standard methods of deaeration of cardiac cavities	Procedure: carbon dioxide insufflation; Carbon dioxide insufflation at a rate of 5 l / min. through the Redon drainage during cardiac surgery (minimally invasive or repeated) during cardiopulmonary bypass; Other Names: carbon dioxide
Other: no carbon dioxide; standard methods of deaeration of cardiac cavities: manual method, change in body position, through the cannula of the ascending aorta, through the drainage of the left ventricle	Procedure: No carbon dioxide insufflation; standard methods of deaeration of cardiac cavities: manual method, change in body position, through the cannula of the ascending aorta, through the drainage of the left ventricle; Other Names: standard methods of deaeration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
delirium: CAM-ICU, 3-D CAM	positive test development of postoperative delirium: Richmond Agitation-Sedation Scale, Confusion Assessment Method-Intensive Care Unit (more than one error) - while in the intensive care unit; positive test the 3-Minute Diagnostic Interview for Confusion Assessment Method (CAM) defined delirium - while in the ward of the department: The CAM algorithm is considered positive if the following features are present: Feature 1) Acute onset or fluctuating course and Feature 2) Inattention and either Feature 3) Disorganized thinking or Feature 4) Altered level of consciousness.	7 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
deaeration time	deaeration time according to transesophageal echocardiography data	intraoperatively
neurocognitive dysfunction	development of neurocognitive dysfunction: Montreal Cognitive Assessment - two days before surgery and 7 days after surgery	7 days after surgery

Collaborators and Investigators

• Sponsor: Meshalkin Research Institute of Pathology of Circulation
• Investigators: Principal Investigator: Alexander V. Bogachev-Prokophiev, MD, PhD, E.Meshalkin National Medical Research Center

Study record dates

Study Major Dates

• Study Start (Actual): June 19, 2020
• Primary Completion (Anticipated): June 20, 2021
• Study Completion (Anticipated): June 20, 2022

Study Registration Dates

• First Submitted: September 1, 2020
• First Submitted That Met QC Criteria: September 8, 2020
• First Posted (Actual): September 14, 2020

Study Record Updates

• Last Update Posted (Actual): September 14, 2020
• Last Update Submitted That Met QC Criteria: September 8, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: cardiac surgery; delirium; carbon dioxide; minimally invasive intervention; redo cardiac surgery
• Other Study ID Numbers: 496

Drug and device information, study documents

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