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

Meshalkin Research Institute of Pathology of Circulation

Status: Unknown

Conditions: Carbon Dioxide

Treatments: Procedure: carbon dioxide insufflation; Procedure: No carbon dioxide insufflation

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT04548687

496

Details and patient eligibility

About

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

Full 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)

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

carbon dioxide insufflation

Active Comparator group

Description:

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

Treatment:

Procedure: carbon dioxide insufflation

no carbon dioxide

Other group

Description:

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

Treatment:

Procedure: No carbon dioxide insufflation