Assessment of Remote EEG Monitoring (REMI-EEG) in Pediatric Emergency and Adult Critical Care Units

NCT ID: NCT05818930

Last Updated: 2024-01-25

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 129 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-08
• Study Completion Date: 2025-10-31

Brief Summary

The goal of this observational study is to compare clinical utility between Remote EEG Monitoring (REMI) and conventional EEG in patients (6 and older) that are undergoing EEG recording in a hospital as part of their routine clinical care. The main question[s] it aims to answer are:

• What is the concurrence of diagnosis made by epileptologist using REMI and full-EEG signals.
• What is the proportion of participants experiencing as seizure at the time of sensor placement, compared between REMI sensor placement and full-EEG placement.

Participants will wear REMI and conventional EEG electrodes at the same time.

Detailed Description

Epitel has developed Epilog, a wireless wearable EEG sensor capable of transmitting EEG to a recording, display, and review platform called REMI (Remote EEG Monitoring). Epitel's REMI platform consists of the REMI tablet and four Epilog sensors. The REMI tablet requires connection to secure WiFi access, and Emergency Department and Intensive Critical Care's IT to open access to http://remi.epitel.com. The four epilog sensors communicate directly with the REMI tablet via Bluetooth connection. REMI synchronizes four Epilog sensors placed by hospital Emergency Department (ED) or intensive care unit (ICU) staff within minutes of patient arrival, thus allowing patients who are suspected of having encephalopathy to be evaluated quickly and prior to initial treatment. REMI securely transmits EEG data to its cloud server where data are processed in near real time using Persyst® Mobile software. Data can then be remotely reviewed by clinical team members.

The objective of this protocol is to demonstrate clinical utility of the Epilog EEG sensors with the REMI monitoring platform in children age 6 through adults in the pediatric emergency department and neurocritical care unit, respectively. Patients meeting entry criteria will be enrolled by a bedside clinical team member who is trained in Epilog sensor placement and use of the REMI platform. All participants will have four Epilog sensors placed, in addition to the standard of care full-EEG. The bedside clinician will be asked to make a "baseline" diagnosis based only on the clinical symptoms.

Conditions

Epilepsy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

REMI vs Conventional EEG

REMI EEG is as Diagnostically useful as conventional EEG at monitoring patients with suspected seizure events.

Group Type: OTHER

REMI

Intervention Type: DIAGNOSTIC_TEST

Diagnostic monitoring

Interventions

REMI

Diagnostic monitoring

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Clinical EEG has been ordered for suspected seizures
• Age 6 years or older

Exclusion Criteria

• Cannot undergo EEG recordings because of severe head or other injury that prevents EEG recording.
• Transferred immediately for an operation
• Hemodynamically unstable (SBP less than 90 mmHg) at time of EEG placement
• Inability to place four REMI EEG sensors.

• Minimum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Epitel, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maija Holsti, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Utah

Amir M Arain, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Utah

Locations

University of Utah

Salt Lake City, Utah, United States

Countries

United States

Other Identifiers

EpitelUtah22

Identifier Type: -

Identifier Source: org_study_id