Carbon Dioxide Insufflation on Cerebral Microemboli

NCT00715845 | Terminated Phase 2

• 1 other identifier: CO200
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Primary outcome will be the number of emboli as measured by transesophageal echocardiogram and transcranial doppler.

  intraoperative

Secondary Outcomes (1)

• Secondary outcome will be the prevalence of new ischemic lesions on diffusion weighted magnetic resonance imaging and neuropsychological impairments

  2 months

Study Arms (1)

2

EXPERIMENTAL

Procedure: Carbon dioxide insufflation

Interventions

Carbon dioxide insufflation PROCEDURE

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.

Also known as: 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)

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Toronto General Hospital/ University Health Network

Toronto, Ontario, M5G 2C4, Canada

Location

MeSH Terms

Conditions

Cardiovascular Diseases; Cognitive Dysfunction; Embolism

Interventions

Heart-Lung Machine; Oxygenators, Membrane; Ultrasonography, Doppler, Transcranial; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Embolism and Thrombosis; Vascular Diseases

Intervention Hierarchy (Ancestors)

Artificial Organs; Surgical Equipment; Equipment and Supplies; Oxygenators; Echoencephalography; Neuroradiography; Neuroimaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiography; Ultrasonography; Ultrasonography, Doppler; Diagnostic Techniques, Neurological; Investigative Techniques; Spectrum Analysis; Chemistry Techniques, Analytical

Study Officials

• Patricia Murphy, BSc, MD, FRCPC

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2008
• First Posted: July 15, 2008
• Study Start: April 1, 2008
• Primary Completion: April 1, 2010
• Study Completion: October 1, 2011
• Last Updated: October 26, 2011

Record last verified: 2011-10

Locations

CA (1)