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

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ClinicalTrials.gov Identifier: NCT04548687
Recruitment Status : Recruiting
First Posted : September 14, 2020
Last Update Posted : September 14, 2020
Sponsor:
Information provided by (Responsible Party):
Meshalkin Research Institute of Pathology of Circulation

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

Condition or disease Intervention/treatment Phase
Carbon Dioxide Procedure: carbon dioxide insufflation Procedure: No carbon dioxide insufflation Not Applicable

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)

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Group 1: patients with planned minimally invasive or repeated cardiac surgery using standard methods of deaeration of cardiac cavities.

Group 2: patients with planned minimally invasive or repeated cardiac surgery using standard methods of deaeration of cardiac cavities, supplemented with carbon dioxide insufflation during surgery

Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Prospective Randomized Clinical Trial "Insufflation of Carbon Dioxide During Minimally Invasive and Repeated Cardiac Surgery"
Actual Study Start Date : June 19, 2020
Estimated Primary Completion Date : June 20, 2021
Estimated Study Completion Date : June 20, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

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 Name: carbon dioxide

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 Name: standard methods of deaeration




Primary Outcome Measures :
  1. delirium: CAM-ICU, 3-D CAM [ Time Frame: 7 days after surgery ]
    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.


Secondary Outcome Measures :
  1. deaeration time [ Time Frame: intraoperatively ]
    deaeration time according to transesophageal echocardiography data

  2. neurocognitive dysfunction [ Time Frame: 7 days after surgery ]
    development of neurocognitive dysfunction: Montreal Cognitive Assessment - two days before surgery and 7 days after surgery



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04548687


Contacts
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Contact: Alexander V. Bogachev-Prokophiev, MD, PhD +73833476029 bogachev.prokophiev@gmail.com
Contact: Sergei A. Budagaev +73833476029 ser.bud.med@gmail.com

Locations
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Russian Federation
"E.Meshalkin National medical research center" of the Ministry of Health of the Russian Federation Recruiting
Novosibirsk, Russian Federation
Contact: Alexander V. Bogachev-Prokophiev, MD, PhD    +73833476029    bogachev.prokophiev@gmail.com   
Contact: Sergei A. Budagaev    +73833476029    ser.bud.med@gmail.com   
Sponsors and Collaborators
Meshalkin Research Institute of Pathology of Circulation
Investigators
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Principal Investigator: Alexander V. Bogachev-Prokophiev, MD, PhD E.Meshalkin National medical research center
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Responsible Party: Meshalkin Research Institute of Pathology of Circulation
ClinicalTrials.gov Identifier: NCT04548687    
Other Study ID Numbers: 496
First Posted: September 14, 2020    Key Record Dates
Last Update Posted: September 14, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Meshalkin Research Institute of Pathology of Circulation:
carbon dioxide
cardiac surgery
delirium
minimally invasive intervention
redo cardiac surgery