Carbon Dioxide Insufflation on Cerebral Microemboli

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University Health Network, Toronto

Status and phase

Terminated
Phase 3
Phase 2

Conditions

Mitral Valve Repair
Cerebral Microemboli
Cognitive Decline
Cardiovascular Disease

Treatments

Procedure: Carbon dioxide insufflation

Study type

Interventional

Funder types

Other

Identifiers

NCT00715845
CO200

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

20 participants in 1 patient group

2
Experimental group
Treatment:
Procedure: Carbon dioxide insufflation

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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