Does Use of Rapid Response EEG Impact Clinical Decision Making

NCT ID: NCT03534258

Last Updated: 2019-08-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

164 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-04-30

Study Completion Date

2019-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Nonconvulsive Status Epilepticus Seizures

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients undergoing clinically ordered EEGs.

Exclusion Criteria

* None
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ceribell Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of California Los Angeles

Los Angeles, California, United States

Site Status

Rush University Medical Center Pob

Chicago, Illinois, United States

Site Status

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Wake Forest Baptist Health

Winston-Salem, North Carolina, United States

Site Status

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 32618687 (View on PubMed)

Other Identifiers

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1825

Identifier Type: -

Identifier Source: org_study_id

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