Clinical trial NCT03534258: Does Use of Rapid Response EEG Impact Clinical Decision Making
Official title: Does Use of Rapid Response EEG Impact Clinical Decision Making
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nonconvulsive Status Epilepticus
Seizures
Lead sponsor: Ceribell Inc.
Sponsor class: INDUSTRY
First posted: 2018-05-23
Enrollment: 164
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing clinically ordered EEGs.

Exclusion Criteria:

* None

Primary outcomes:
measure: Change in physicians' diagnosis decision
timeFrame: through study completion, an average of 1 year
measure: Change in physicians' diagnosis confidence
timeFrame: through study completion, an average of 1 year
measure: Change in physicians' treatment decision
timeFrame: through study completion, an average of 1 year
measure: Change in physicians' treatment confidence
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Time from order to EEG arrival
timeFrame: through study completion, an average of 1 year
measure: Set up time
timeFrame: through study completion, an average of 1 year
measure: Ease of use
timeFrame: through study completion, an average of 1 year
measure: Signal Quality of EEG
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California Los Angeles
state: California
city: Chicago
country: United States
facility: Rush University Medical Center Pob
state: Illinois
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Health
state: North Carolina
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
Study officials:
References:
citation: 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.