Clinical trial NCT05818930: Assessment of Remote EEG Monitoring (REMI-EEG) in Pediatric Emergency and Adult Critical Care Units
Official title: Assessment of Remote EEG Monitoring (REMI-EEG) in Pediatric Emergency and Adult Critical Care Units
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Epilepsy
Lead sponsor: Epitel, Inc.
Sponsor class: INDUSTRY
First posted: 2023-04-19
Enrollment: 129
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Comparison of clinician's diagnostic impression between REMI and conventional electroencephalograph data.
timeFrame: Through the length of time that a patient is actively monitored using both REMI and a full electroencephalograph (up to 24 hours).
Secondary outcomes:
measure: Comparison of time to identify epileptiform EEG signals between REMI and conventional electroencephalograph data.
timeFrame: Time Frame: Through the time of sensor placement for both REMI sensors and a full electroencephalograph (approximately up to one hour).
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: University of Utah
name: Maija Holsti, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Utah
name: Amir M Arain, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: