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Seizures After Cardiac Surgery -- A Study With Continuous EEG Monitoring

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ClinicalTrials.gov Identifier: NCT01291992
Recruitment Status : Completed
First Posted : February 9, 2011
Last Update Posted : March 13, 2018
Sponsor:
Information provided by (Responsible Party):
Michael Chu, Lawson Health Research Institute

Brief Summary:
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 or disease
Non-convulsive Seizures

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.


Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Seizures After Cardiac Surgery -- A Prospective Study With Continuous EEG Monitoring
Actual Study Start Date : September 2010
Actual Primary Completion Date : October 2012
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine


Group/Cohort
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.



Primary Outcome Measures :
  1. Frequency of non-convulsive seizures in postoperative cardiac surgery patients [ Time Frame: Immediate postoperative monitoring with continuous EEG ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01291992


Locations
Canada, Ontario
London Health Sciences Centre, University Hospital
London, Ontario, Canada, N6A 5A5
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
Principal Investigator: Michael Chu, MD London Health Sciences Centre, University Hospital

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Michael Chu, Dr. Michael Chu, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT01291992     History of Changes
Other Study ID Numbers: R-10-259
17107 ( Other Identifier: REB )
First Posted: February 9, 2011    Key Record Dates
Last Update Posted: March 13, 2018
Last Verified: March 2018

Keywords provided by Michael Chu, Lawson Health Research Institute:
Non-convulsive seizures
Cardiac Surgery
Postop
24 hour EEG Monitoring

Additional relevant MeSH terms:
Seizures
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms