Does Use of Rapid Response EEG Impact Clinical Decision Making

Does Use of Rapid Response EEG Impact Clinical Decision Making

Sponsors

Lead Sponsor: Ceribell Inc.

Source 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.

Overall Status Completed
Start Date 2018-04-30
Completion Date 2019-07-31
Primary Completion Date 2019-04-30
Study Type Observational
Primary Outcome
Measure Time Frame
Change in physicians' diagnosis decision through study completion, an average of 1 year
Change in physicians' diagnosis confidence through study completion, an average of 1 year
Change in physicians' treatment decision through study completion, an average of 1 year
Change in physicians' treatment confidence through study completion, an average of 1 year
Secondary Outcome
Measure Time Frame
Time from order to EEG arrival through study completion, an average of 1 year
Set up time through study completion, an average of 1 year
Ease of use through study completion, an average of 1 year
Signal Quality of EEG through study completion, an average of 1 year
Enrollment 164
Condition
Intervention

Intervention Type: Device

Intervention Name: Ceribell Rapid Response EEG, Survey

Description: 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.

Eligibility

Sampling Method:

Non-Probability Sample

Criteria:

Inclusion Criteria: - Patients undergoing clinically ordered EEGs. Exclusion Criteria: - None

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Location
Facility:
University of California Los Angeles | Los Angeles, California, 90024, United States
Rush University Medical Center Pob | 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
Location Countries

United States

Verification Date

2019-08-01

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Acronym DECIDE
Patient Data No
Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

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