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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04548687

Acronym

CAR-DRIVER

Enrollment

120

Registered

2020-09-14

Start date

2020-06-19

Completion date

2022-06-20

Last updated

2020-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carbon Dioxide

Keywords

carbon dioxide, cardiac surgery, delirium, minimally invasive intervention, redo cardiac surgery

Brief summary

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

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)

Interventions

PROCEDUREcarbon 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

PROCEDURENo 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

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

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame	Description
delirium: CAM-ICU, 3-D CAM	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

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

Countries

Russia

Contacts

Primary ContactAlexander V. Bogachev-Prokophiev, MD, PhD

bogachev.prokophiev@gmail.com+73833476029

Backup ContactSergei A. Budagaev

ser.bud.med@gmail.com+73833476029

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026