a Randomized Clinical Trial Evaluating the Effectiveness of Carbon Dioxide Use in Cardiac Surgery

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

Detailed Description
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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)

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

Conditions
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Carbon Dioxide

Intervention / Treatment
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* Procedure: carbon dioxide insufflation
* Procedure: No carbon dioxide insufflation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: carbon dioxide insufflation<br>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<br>* Carbon dioxide insufflation at a rate of 5 l / min. through the Redon drainage during cardiac surgery (minimally invasive or repeated) during cardiopulmonary bypass<br>* Other names: carbon dioxide;|
| Other: no carbon dioxide<br>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<br>* 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<br>* Other names: standard methods of deaeration;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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carbon dioxide, cardiac surgery, delirium, minimally invasive intervention, redo cardiac surgery