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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-19

Study Completion Date

2022-06-20

Brief Summary

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

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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)

Conditions

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Carbon Dioxide

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type ACTIVE_COMPARATOR

carbon dioxide insufflation

Intervention Type 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

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

Group Type OTHER

No carbon dioxide insufflation

Intervention Type 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

Interventions

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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

Intervention Type 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

Intervention Type PROCEDURE

Other Intervention Names

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carbon dioxide standard methods of deaeration

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No