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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ceribell Rapid Response EEG, Survey | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in physicians' diagnosis decision | Physician will record their diagnostic assessment of seizure in Yes or No. | through study completion, an average of 1 year |
| Change in physicians' diagnosis confidence | Physician will rate their diagnosis confidence with a score between 1 to 5 | through study completion, an average of 1 year |
| Change in physicians' treatment decision | Physician will record their treatment decision in Yes or No. | through study completion, an average of 1 year |
| Change in physicians' treatment confidence | Physician will rate their treatment confidence with a score between 1 to 5 | through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Time from order to EEG arrival | Time from EEG order to EEG arrival will be recorded for both Ceribell EEG and conventional EEG | through study completion, an average of 1 year |
| Set up time | Time from EEG arrival to the first EEG recording will be recorded for both Ceribell EEG and conventional EEG |
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Inclusion Criteria:
Exclusion Criteria:
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The study will involve two groups of subjects:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California Los Angeles | Los Angeles | California | 90024 | United States | ||
| Rush University Medical Center Pob |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32618687 | Derived | Vespa PM, Olson DM, John S, Hobbs KS, Gururangan K, Nie K, Desai MJ, Markert M, Parvizi J, Bleck TP, Hirsch LJ, Westover MB. Evaluating the Clinical Impact of Rapid Response Electroencephalography: The DECIDE Multicenter Prospective Observational Clinical Study. Crit Care Med. 2020 Sep;48(9):1249-1257. doi: 10.1097/CCM.0000000000004428. |
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| ID | Term |
|---|---|
| D013226 | Status Epilepticus |
| D012640 | Seizures |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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| through study completion, an average of 1 year |
| Ease of use | Ease of use will be recorded with a score of 1-5 | through study completion, an average of 1 year |
| Signal Quality of EEG | 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 | through study completion, an average of 1 year |
| Chicago |
| Illinois |
| 60612 |
| United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Wake Forest Baptist Health | Winston-Salem | North Carolina | 27157 | United States |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |