Insufflation of Carbon Dioxide During Cardiac Surgery as Prevention Neurologic Complications

Not Applicable

• Conditions: Air Embolism; Neurological Damage
• Interventions: Procedure: conventional prophylaxis of aeroembolism; Procedure: conventional prophylaxis plus CO2 insufflation; Procedure: cardiac surgery with opening of heart chambers

• Registration Number: NCT02340741
• Lead Sponsor: Meshalkin Research Institute of Pathology of Circulation

Brief Summary

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

Detailed Description

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).

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-12-16
• Study First Submitted QC: 2015-01-16
• Study First Posted: 2015-01-19
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-19
• Last Update Posted: 2016-03-22
• Primary Completion: 2017-09
• Study Completion: 2017-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 334

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
conventional prophylaxis of aeroembolism	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.
conventional prophylaxis of aeroembolism	cardiac surgery with opening of heart chambers	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.
conventional prophylaxis plus CO2 insufflation	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.
conventional prophylaxis plus CO2 insufflation	cardiac surgery with opening of heart chambers	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
hospital mortality	14 days

Trial Locations

Locations (1)

Novosibirsk State Research Institute of Circulation Pathology; 🇷🇺 Novosibirsk, Novosibirsk territory, Russian Federation