Insufflation of Carbon Dioxide During Cardiac Surgery as Prevention Neurologic Complications

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

334 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2017-09-30

Brief Summary

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Effect of intraoperative insufflation of carbon dioxide on the neurologic complications in the early postoperative period after open cardiac surgery.

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Detailed Description

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Arterial air embolism in cardiac surgery is not a rare complication, leading to neurological damage in the early postoperative period of 3-5%. Insufflation of carbon dioxide (CO2) into the operative field to prevent cerebral or myocardial damage by air embolism is reported since 1967 in open heart surgery (Selman MW et al. 1967).

Carbon dioxide fills the thoracic cavity by gravity and replaces air if adequately insufflated. Because solubility of CO2 is better than that of air, occlusion or flow disruption in arteries of the brain or the heart is thought to be diminished. Despite carefully performed deairing procedures as puncturing of the ascending aorta and cardiac massage, transcranial Doppler studies revealed large amounts of emboli during the first ejections of the beating heart (van der Linden J et al. 1991). In patiens with minimally invasive approach and redo valve surgery, deairing of the cardiac chambers has become more difficult.

Although the use of carbon dioxide when filling in the surgical field, as the prevention of air embolism reduces the number of intracardiac emboli according to transesophageal echocardiography there is no evidence of a sustained reduction in cerebrovascular events (G. Salvatore al. 2009).

Conditions

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Air Embolism Neurological Damage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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conventional prophylaxis of aeroembolism

Procedure: cardiac surgery with opening of heart chambers.

Will be including 167 patients to undergo cardiac surgery. After the main operation phase all heart cavities are sealed, left vent drainage is stopped, ascending aorta is punctured and cardiac massage is performed, ventilation is started and the heart is filled with volume. Operating table is positioned in the Trendelenburg position, and aorta is opened. The amount of air in the cavities is evaluated by transesophageal echocardiography.

Group Type OTHER

conventional prophylaxis of aeroembolism

Intervention Type PROCEDURE

167 patients will be enrolled. Will perform standard way of aeroembolism prevention

cardiac surgery with opening of heart chambers

Intervention Type PROCEDURE

Patients with different clinical diagnoses, which is planned to cardiac surgery with the opening heart cavities

conventional prophylaxis plus CO2 insufflation

Procedure: cardiac surgery with opening of heart chambers.

Will be including 167 patients to undergo cardiac surgery. After the main phase of the operation standard measures of aeroembolism prevention are carried out. The amount of air in the cavities is evaluated by transesophageal echocardiography.

Group Type OTHER

conventional prophylaxis plus CO2 insufflation

Intervention Type PROCEDURE

167 patients will be enrolled. Will perform standard way of aeroembolism prevention and insufflation of carbon dioxide

cardiac surgery with opening of heart chambers

Intervention Type PROCEDURE

Patients with different clinical diagnoses, which is planned to cardiac surgery with the opening heart cavities

Interventions

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conventional prophylaxis of aeroembolism

167 patients will be enrolled. Will perform standard way of aeroembolism prevention

Intervention Type PROCEDURE

conventional prophylaxis plus CO2 insufflation

167 patients will be enrolled. Will perform standard way of aeroembolism prevention and insufflation of carbon dioxide

Intervention Type PROCEDURE

cardiac surgery with opening of heart chambers

Patients with different clinical diagnoses, which is planned to cardiac surgery with the opening heart cavities

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Able to sign Informed Consent and Release of Medical Information forms
* Age 18 - 70 years
* Patients scheduled on cardiac surgery with opening cavities

Exclusion Criteria

* History of stroke and TIA
* Significant carotid artery stenosis
* Presence of initial severe encephalopathy
* Re-clamping of the aorta
* Emergency surgery

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No