Carbon Dioxide Insufflation on Cerebral Microemboli

Cardiovascular Disease Clinical Trial

Official title: Effects of Carbon Dioxide Insufflation on Cerebral Microemboli During Cardiopulmonary Bypass: A Randomised Trial Correlating Embolic Load & Neurologic Outcomes.

Status Terminated

Clinical Trial Summary

The purpose of this study is to determine if blowing carbon dioxide into the surgical field during open-heart surgery to displace retained chest cavity air from the atmosphere will decrease the number of microembolic being introduced into the heart chambers and brain.

Clinical Trial Description

Although open-heart surgery is widely used throughout the world, from 1 to 4% of patients experience neurological impairment such as impairment of memory, language and motor skills after surgery. The cause for such cognitive impairment is thought to be air microemboli (very small bubbles of air) being introduced into the blood circulation of the brain from the heart. These air microemboli are introduced from the surgical field and/or from the heart-lung machine. During open-heart surgery, a patient's blood circulation is supported by a heart-lung machine (cardiopulmonary bypass) while the surgeon is replacing or repairing a valve or performing coronary artery bypass surgery. During valve surgery, chambers of the heart are open to room air, causing an introduction of air into the heart. Despite careful de-airing (removal of air) procedures during open-heart surgery, studies revealed that air microemboli are still formed. Past research studies have shown that carbon dioxide (CO2) filling the chest cavity by means of gravity and replacing the room air may help to decrease the amount of microemboli reaching the brain.

CO2 is 50% heavier than room air. Unlike room air, CO2 dissolves more quickly in blood and tissue (> 25 times more soluble in blood and tissue than air) whereas air contains nitrogen, which does not dissolve easily in the blood. In either case, the emboli made of air or CO2 can block the arteries of the brain causing cognitive impairment. Due to the properties of air and CO2, CO2 emboli may be tolerated much better than air emboli.

This is a single-centre, double-blind, placebo-controlled study, randomizing 100 patients undergoing elective mitral valve repair +/- coronary artery bypass grafting. Patients will be divided into 2 groups: (n=100), 50 patients will be receiving carbon dioxide insufflated and 50 patients will not. The number of microemboli will be ascertained by an intraoperative transesophageal echocardiography and transcranial doppler. Three to seven days after surgery, a magnetic resonance imaging of the brain will be done to assess for any cerebral ischemic lesions. Plus, a battery of neuropsychologic tests will be done preoperatively and 2 months postoperatively. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Cerebral Microemboli
• Cognition Disorders
• Cognitive Decline
• Mitral Valve Repair

• NCT number: NCT00715845
• Study type: Interventional
• Source: University Health Network, Toronto
• Status: Terminated
• Phase: Phase 2/Phase 3
• Start date: April 2008
• Completion date: October 2011