Clinical trial NCT00715845: Carbon Dioxide Insufflation on Cerebral Microemboli
Official title: Effects of Carbon Dioxide Insufflation on Cerebral Microemboli During Cardiopulmonary Bypass: A Randomised Trial Correlating Embolic Load & Neurologic Outcomes.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Cardiovascular Disease
Mitral Valve Repair
Cerebral Microemboli
Cognitive Decline
Keywords: cardiovascular disease
embolism
microemboli
cognitive decline
mitral valve repair
cerebral microemboli
coronary artery bypass graft
CABG
transcranial doppler
transesophageal echocardiogram
magnetic resonance imaging
carbon dioxide
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2008-07-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* provide informed consent
* male or female who are 18 years of age or older
* elective patients to undergo mitral valve repair +/- coronary artery bypass surgery
* ability to read and write

Exclusion Criteria:

* patients with a history of stroke, TIA, carotid vascular disease
* patients with a contraindication to TEE or MRI
* patients with an active history of drug/alcohol dependence or abuse history

Primary outcomes:
measure: Primary outcome will be the number of emboli as measured by transesophageal echocardiogram and transcranial doppler.
timeFrame: intraoperative
Secondary outcomes:
measure: Secondary outcome will be the prevalence of new ischemic lesions on diffusion weighted magnetic resonance imaging and neuropsychological impairments
timeFrame: 2 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto General Hospital/ University Health Network
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Patricia Murphy, BSc, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References: