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Does Use of Rapid Response EEG Impact Clinical Decision Making (DECIDE)

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ClinicalTrials.gov Identifier: NCT03534258
Recruitment Status : Completed
First Posted : May 23, 2018
Last Update Posted : August 20, 2019
Sponsor:
Information provided by (Responsible Party):
Ceribell Inc.

Brief Summary:
This study is designed as a prospective, non-randomized, observational, multicenter clinical trial. The primary aim of this study is to observe if the use of the rapid responds electroencephalography (EEG) system impacts physician decision making. Secondary aims include exploring the safety and performance information of the Ceribell EEG system compared to conventional EEG system. The study will recruit physicians (Faculty physicians and Trainees) at up to five institutions and examine the impact of rapid response EEG when providing care to patients in whom EEG recording has been ordered for clinical reasons.

Condition or disease Intervention/treatment
Nonconvulsive Status Epilepticus Seizures Device: Ceribell Rapid Response EEG, Survey

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Study Type : Observational
Actual Enrollment : 164 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Does Use of Rapid Response EEG Impact Clinical Decision Making
Actual Study Start Date : April 30, 2018
Actual Primary Completion Date : April 30, 2019
Actual Study Completion Date : July 31, 2019

Resource links provided by the National Library of Medicine



Intervention Details:
  • Device: Ceribell Rapid Response EEG, Survey
    This trial will qualitatively examine how information from rapid response and conventional EEG data changes physicians' diagnostic suspicion or their treatment decisions and confidence levels. In addition, the results will examine the mean time to EEG lead placement, and ease of use.


Primary Outcome Measures :
  1. Change in physicians' diagnosis decision [ Time Frame: through study completion, an average of 1 year ]
    Physician will record their diagnostic assessment of seizure in Yes or No.

  2. Change in physicians' diagnosis confidence [ Time Frame: through study completion, an average of 1 year ]
    Physician will rate their diagnosis confidence with a score between 1 to 5

  3. Change in physicians' treatment decision [ Time Frame: through study completion, an average of 1 year ]
    Physician will record their treatment decision in Yes or No.

  4. Change in physicians' treatment confidence [ Time Frame: through study completion, an average of 1 year ]
    Physician will rate their treatment confidence with a score between 1 to 5


Secondary Outcome Measures :
  1. Time from order to EEG arrival [ Time Frame: through study completion, an average of 1 year ]
    Time from EEG order to EEG arrival will be recorded for both Ceribell EEG and conventional EEG

  2. Set up time [ Time Frame: through study completion, an average of 1 year ]
    Time from EEG arrival to the first EEG recording will be recorded for both Ceribell EEG and conventional EEG

  3. Ease of use [ Time Frame: through study completion, an average of 1 year ]
    Ease of use will be recorded with a score of 1-5

  4. Signal Quality of EEG [ Time Frame: through study completion, an average of 1 year ]
    Signal Quality of Ceribell EEG as measured with Hjorth parameters (Hjorth Activity, Hjorth Mobility, Hjorth Complexity) will be compared to signal quality of conventional EEG acquired from the same patients



Information from the National Library of Medicine

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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

The study will involve two groups of subjects:

  1. Physicians (faculty and trainees), who will be asked to fill out a nonsensitive questionnaire. These are members of Epilepsy and Neuro-ICU team (attendings, fellows, or residents) who are actively involved in the care of patients and know the patient's history of present illness.
  2. Patients undergoing clinically ordered EEGs.
Criteria

Inclusion Criteria:

  • Patients undergoing clinically ordered EEGs.

Exclusion Criteria:

  • None

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): NCT03534258


Locations
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United States, California
University of California Los Angeles
Los Angeles, California, United States, 90024
United States, Illinois
Rush University Medical Center Pob
Chicago, Illinois, United States, 60612
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, North Carolina
Wake Forest Baptist Health
Winston-Salem, North Carolina, United States, 27157
United States, Texas
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Sponsors and Collaborators
Ceribell Inc.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ceribell Inc.
ClinicalTrials.gov Identifier: NCT03534258    
Other Study ID Numbers: 1825
First Posted: May 23, 2018    Key Record Dates
Last Update Posted: August 20, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Seizures
Status Epilepticus
Neurologic Manifestations
Nervous System Diseases