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Nonconvulsive Seizure Identification on Quantitative EEG by Neuro ICU Nurses

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ClinicalTrials.gov Identifier: NCT02082873
Recruitment Status : Completed
First Posted : March 10, 2014
Last Update Posted : May 17, 2019
Sponsor:
Information provided by (Responsible Party):
Duke University

Brief Summary:
This research is being conducted to determine if Neuroscience intensive care unit (ICU) nurses are able to identify seizures by reviewing quantitative EEG (qEEG) that is running at the bedside. QEEG is the application of mathematical and analytical techniques to analyze EEG signals. Several hours of data can be displayed on a single screen in several graphical panels. Routine evaluation of EEG data consists of manual inspection of each page of EEG data by a trained neurophysiologist (a neuro ICU doctor) and can be quite time-consuming. In most cases, this data can only be reviewed intermittently and interpretation is almost always relayed to the primary clinical team after the seizures have occurred. Theoretically,qEEG graphical displays can provide a simplified view of complex EEG data that could possibly be used by non-neurophysiologists, such as Neuro ICU nurses. Our hypothesis is that Neuro ICU nurses are able to accurately identify recurrent seizures in real-time.

Condition or disease
Nonconvulsive Seizures

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Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Trial of Nonconvulsive Electrographic Seizure Detection by Nurses in the Adult Neuro ICU Using a Panel of Quantitative EEG Trends
Actual Study Start Date : January 2015
Actual Primary Completion Date : February 2019
Actual Study Completion Date : February 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Seizures




Primary Outcome Measures :
  1. Sensitivity of nurses ability to detect recurrent NCS on QEEG [ Time Frame: within 3 months after patient enrollment ]

    Neuro ICU nurses will be asked to check the qEEG screen hourly and record the number of seizures (similar in appearance to the sentinel seizure qEEG print out) seen on the qEEG display. At one hour intervals the nurse will mark one of the following options: no seizures, 1-2 seizures, 3-5 seizures, 6-10 seizures or >10 seizures. The total duration of the study will be for 24 hours or when the treating physician discontinues continuous EEG monitoring, whichever is shorter.

    After completing enrollment, board-certified neurophysiologists and study authors (SS and CS) will review the raw EEG data independently to identify seizures. Each hour of raw EEG will be placed into the follow categories: no seizures, 1-2 seizure, 3-5 seizures, 6-10 seizures or >10 seizures. Standard test characteristics (sensitivity, specificity, ect) will be calculated comparing the nurses responses to the gold standard of raw EEG review.



Secondary Outcome Measures :
  1. Specificity of nurses ability to detect recurrent NCS on QEEG [ Time Frame: Within 3 months of patient enrollment ]

    Neuro ICU nurses will be asked to check the qEEG screen hourly and record the number of seizures (similar in appearance to the sentinel seizure qEEG print out) seen on the qEEG display. At one hour intervals the nurse will mark one of the following options: no seizures, 1-2 seizures, 3-5 seizures, 6-10 seizures or >10 seizures. The total duration of the study will be for 24 hours or when the treating physician discontinues continuous EEG monitoring, whichever is shorter.

    After completing enrollment, board-certified neurophysiologists and study authors (SS and CS) will review the raw EEG data independently to identify seizures. Each hour of raw EEG will be placed into the follow categories: no seizures, 1-2 seizure, 3-5 seizures, 6-10 seizures or >10 seizures. Standard test characteristics (sensitivity, specificity, ect) will be calculated comparing the nurses responses to the gold standard of raw EEG review.




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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
30 NeuroICU patients and 40 NeuroICU nurses
Criteria

Inclusion Criteria:

  1. Age of 18 years or older at time of consent
  2. Patients undergoing cEEG monitoring to evaluate for the presence of NCS
  3. Admission or pending transfer to the adult Neuro ICU
  4. Informed consent by patient or patient's legally authorized representative (LAR)
  5. One or more NCS identified on cEEG monitoring, confirmed by the clinical neurophysiology team

Exclusion Criteria:

  1. Anticipated discharge from NICU < 24 hours
  2. Anticipated duration of cEEG monitoring < 24 hours
  3. Suspected diagnosis of brain death
  4. Open head wound or bandage preventing application of majority of EEG electrodes
  5. Treating physician deems not appropriate for subject participation
  6. Seizures lasting more than 1 hour in duration
  7. Convulsive seizures without concern for NCS

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): NCT02082873


Locations
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United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Duke University
Investigators
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Principal Investigator: Christa Swisher, MD Duke University
Publications of Results:
Other Publications:

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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02082873    
Other Study ID Numbers: Pro00052133
First Posted: March 10, 2014    Key Record Dates
Last Update Posted: May 17, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Duke University:
Quantitative EEG
Nonconvulsive seizures
ICU EEG monitoring
Additional relevant MeSH terms:
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Seizures
Neurologic Manifestations
Nervous System Diseases