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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by Lawson Health Research Institute.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT01291992
First received: February 7, 2011
Last updated: February 8, 2011
Last verified: February 2011
  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
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

Resource links provided by NLM:


Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • 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
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.

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
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
  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: NCT01291992

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         
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
Principal Investigator: Michael Chu, MD London Health Sciences Centre, University Hospital
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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:
Non-convulsive seizures
Cardiac Surgery
Postop
24 hour EEG Monitoring

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

ClinicalTrials.gov processed this record on November 20, 2014