Does Use of Rapid Response EEG Impact Clinical Decision Making

NCT03534258 | Completed FDA Device

• 1 other identifier: 1825
• Study Type: observational
• Target: 164
• Locations: 1 country
• Sites: 5

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.

Conditions

Nonconvulsive Status Epilepticus; Seizures

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (4)

• 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

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients undergoing clinically ordered EEGs.

You may not qualify if:

• None

Sponsors & Collaborators

• Ceribell Inc.: lead

Study Sites (5)

University of California Los Angeles

Los Angeles, California, 90024, United States

Location

Rush University Medical Center Pob

Chicago, Illinois, 60612, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Wake Forest Baptist Health

Winston-Salem, North Carolina, 27157, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Related Publications (1)

• 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.

  PMID: 32618687 DERIVED

MeSH Terms

Conditions

Status Epilepticus; Seizures

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2018
• First Posted: May 23, 2018
• Study Start: April 30, 2018
• Primary Completion: April 30, 2019
• Study Completion: July 31, 2019
• Last Updated: August 20, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)