Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
study of the efficacy and safety of carbon dioxide in cardiac surgery: repeated or minimally invasive
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)
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| carbon dioxide insufflation | Active Comparator | 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 |
|
| no carbon dioxide | Other | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| carbon dioxide insufflation | Procedure | Carbon dioxide insufflation at a rate of 5 l / min. through the Redon drainage during cardiac surgery (minimally invasive or repeated) during cardiopulmonary bypass |
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alexander V. Bogachev-Prokophiev, MD, PhD | Contact | +73833476029 | bogachev.prokophiev@gmail.com | |
| Sergei A. Budagaev | Contact | +73833476029 | ser.bud.med@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Alexander V. Bogachev-Prokophiev, MD, PhD | E.Meshalkin National medical research center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| "E.Meshalkin National medical research center" of the Ministry of Health of the Russian Federation | Recruiting | Novosibirsk | Russia |
Not provided
| ID | Term |
|---|---|
| D003693 | Delirium |
| ID | Term |
|---|---|
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D002245 | Carbon Dioxide |
| ID | Term |
|---|---|
| D017554 | Carbon Compounds, Inorganic |
| D007287 | Inorganic Chemicals |
| D005740 | Gases |
| D010087 | Oxides |
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
|
| No carbon dioxide insufflation | Procedure | 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 |
|
|
| 7 days after surgery |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D017601 |
| Oxygen Compounds |