Insufflation of Carbon Dioxide During Cardiac Surgery as Prevention Neurologic Complications

Study Overview
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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.

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).

Official Title
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Assessing of Carbon Dioxide Insufflation on the Neurological Complications During Open Heart Operations

Conditions
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Air Embolism, Neurological Damage

Intervention / Treatment
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* Procedure: conventional prophylaxis of aeroembolism
* Procedure: conventional prophylaxis plus CO2 insufflation
* Procedure: cardiac surgery with opening of heart chambers


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: conventional prophylaxis of aeroembolism<br>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. | Procedure: conventional prophylaxis of aeroembolism<br>* 167 patients will be enrolled. Will perform standard way of aeroembolism prevention<br>Procedure: cardiac surgery with opening of heart chambers<br>* Patients with different clinical diagnoses, which is planned to cardiac surgery with the opening heart cavities<br>|
| Other: conventional prophylaxis plus CO2 insufflation<br>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. | Procedure: conventional prophylaxis plus CO2 insufflation<br>* 167 patients will be enrolled. Will perform standard way of aeroembolism prevention and insufflation of carbon dioxide<br>Procedure: cardiac surgery with opening of heart chambers<br>* Patients with different clinical diagnoses, which is planned to cardiac surgery with the opening heart cavities<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative neurological disorders (stroke, psychosis,encephalopathy), as measured by Confusion Assessment Method for the ICU, Richmond Agitation-Sedation Scale, Standardized Mini-Mental State Examination | conducting tests: Confusion Assessment Method for the ICU, Richmond Agitation-Sedation Scale, Standardized Mini-Mental State Examination | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hospital mortality |  | 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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carbon dioxide, postoperative cerebrovascular complications, air embolism