Seizures After Cardiac Surgery -- A Study With Continuous EEG Monitoring
Recruitment status was Recruiting
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Purpose
The aim of this study is to determine the frequency of nonconvulsive seizures after cardiac surgery using an electroencephalogram or EEG, which records brainwaves through the scalp.
| Condition |
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Non-convulsive Seizures |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Seizures After Cardiac Surgery -- A Prospective Study With Continuous EEG Monitoring |
- Frequency of non-convulsive seizures in postoperative cardiac surgery patients [ Time Frame: Immediate postoperative monitoring with continuous EEG ] [ Designated as safety issue: No ]Immediately after surgery, while still sedated and in the cardiac surgery recovery unit, 9 sticker electrodes will be applied to the skin just below the hairline, which record brain activity onto a computer. The EEG will be recorded for 24 hours. This brain activity (EEG) will later be interpreted by a neurologist who will be looking for evidence of seizure activity in the brain waves. Other relevant information: age, sex, the nature of other health problems, drugs used, complications and whether or not seizures are found will be stored on our computer for further evaluation.
| Estimated Enrollment: | 150 |
| Study Start Date: | September 2010 |
| Estimated Study Completion Date: | January 2013 |
| Estimated Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
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Continuous EEG Monitoring
Immediately after surgery, while still sedated and in the cardiac surgery recovery unit, 9 sticker electrodes applied to the skin just below the hairline, which record brain activity onto a computer. The EEG will be recorded for 24 hours. This brain activity (EEG) will later be interpreted by a neurologist who will be looking for evidence of seizure activity in the brain waves. Other relevant information: age, sex, the nature of other health problems, drugs used, complications and whether or not seizures are found will be stored on our computer for further evaluation.
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Detailed Description:
Background: Most patients do not have any neurological complications after cardiac surgery, but fewer than 1% may have a seizure (abnormal brain activity), with or without a convulsion. This can be due to a reaction to certain types of drugs or less commonly stroke or inflammation. Some seizures in post-operative and intensive care unit patients do not result in convulsions, but rather the abnormal brain activity simply causes confusion or unresponsiveness. The incidence of this type of "nonconvulsive"seizure after cardiac surgery is unknown.
Purpose of the study: The aim of this study is to determine the frequency of nonconvulsive seizures after cardiac surgery using an electroencephalogram or EEG, which records brainwaves through the scalp.
Design of the study: The investigators target is to enroll 150 patients undergoing cardiac surgery. The investigators are including patients greater than 18 years of age who are admitted to the CSRU immediately after cardiac surgery. Included patients are of normal mentation and are able to give their own consent. The investigators will exclude only those patients for whom technical issues prevent us from recording the EEG.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
All patients admitted to the CSRU postoperatively who have given informed consent to have immediate and continous EEG monitoring for the first 24 hours postoperatively
Inclusion Criteria:
- All adult patients able to give informed consent and undergoing cardiac surgery
Exclusion Criteria:
- Inability to record subhairline EEG data due to technical/mechanical reasons Patients not giving informed consent
Contacts and Locations| Canada, Ontario | |
| London Health Sciences Centre, University Hospital | Recruiting |
| London, Ontario, Canada, N6A 5A5 | |
| Contact: Stephanie A Fox, BA, RRT 519-685-8500 ext 35031 Stephanie.Fox@lhsc.on.ca | |
| Contact: Michael Chu, MD 519-685-8500 ext 33479 Michael.Chu@lhsc.on.ca | |
| Principal Investigator: Michael Chu, MD | |
| Principal Investigator: Bryan Young, MD | |
| Principal Investigator: | Michael Chu, MD | London Health Sciences Centre, University Hospital |
More Information
Publications:
| Responsible Party: | Dr. Michael Chu, London Health Sciences Centre, University Hospital |
| ClinicalTrials.gov Identifier: | NCT01291992 History of Changes |
| Other Study ID Numbers: | R-10-259, 17107 |
| Study First Received: | February 7, 2011 |
| Last Updated: | February 8, 2011 |
| Health Authority: | Canada: Ethics Review Committee |
Keywords provided by Lawson Health Research Institute:
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Non-convulsive seizures Cardiac Surgery Postop 24 hour EEG Monitoring |
Additional relevant MeSH terms:
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Seizures Epilepsy Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Neurologic Manifestations Signs and Symptoms |
ClinicalTrials.gov processed this record on May 23, 2013