Carbon Dioxide Insufflation on Cerebral Microemboli

This study has been terminated.
(ran out of funding)
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00715845
First received: June 17, 2008
Last updated: October 25, 2011
Last verified: October 2011
  Purpose

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.


Condition Intervention Phase
Cardiovascular Disease
Mitral Valve Repair
Cerebral Microemboli
Cognitive Decline
Procedure: Carbon dioxide insufflation
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effects of Carbon Dioxide Insufflation on Cerebral Microemboli During Cardiopulmonary Bypass: A Randomised Trial Correlating Embolic Load & Neurologic Outcomes.

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • Primary outcome will be the number of emboli as measured by transesophageal echocardiogram and transcranial doppler. [ Time Frame: intraoperative ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary outcome will be the prevalence of new ischemic lesions on diffusion weighted magnetic resonance imaging and neuropsychological impairments [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: April 2008
Study Completion Date: October 2011
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 2 Procedure: Carbon dioxide insufflation
For baseline evaluations, all patients will undergo a battery of neuropsychological testing after obtaining written informed consent and before cardiac surgery. A transesophageal echocardiography and a transcranial doppler will be performed for intraoperative evaluations. For post-operative evaluations, patients will undergo a diffusion-weighted magnetic resonance imaging three to seven days after surgery and have a repeat neuropsychological assessment at six to eight weeks post cardiac surgery. All patients will undergo cardiopulmonary bypass using the same equipment and technique. Patients in both groups will receive a jackson-pratt drain as a gas diffuser. The jackson-pratt drain will be placed 5 cm below the cardiothoracic wound opening adjacent to the diaphragm and if the patient is randomized to carbon dioxide, the flow will be set at 2 litre/min.
Other Names:
  • transeophageal echocardiogram (agilent sonos 5500)
  • cardiopulmonary bypass circuit (sorin S3 roller pump)
  • cardiotomy suction reservoir (dideco)
  • membrane oxygenator (gish vision)
  • transcranial doppler (spencer technologies PMD 100)
  • magnetic resonance imaging (GE)

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00715845

Locations
Canada, Ontario
Toronto General Hospital/ University Health Network
Toronto, Ontario, Canada, M5G 2C4
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: Patricia Murphy, BSc, MD, FRCPC University Health Network, Toronto
  More Information

No publications provided

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT00715845     History of Changes
Other Study ID Numbers: CO200
Study First Received: June 17, 2008
Last Updated: October 25, 2011
Health Authority: Canada: Ethics Review Committee

Keywords provided by University Health Network, Toronto:
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

Additional relevant MeSH terms:
Cardiovascular Diseases
Cognition Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on October 21, 2014