Point-of-care EEG in the Pediatric Emergency Department

The Role of Point-of-care EEG in the Pediatric Emergency Department

The researchers investigate the use of a simplified electroencephalogram (point-of-care EEG) in the pediatric emergency department for children with impaired consciousness or an ongoing epileptic seizure ("status epilepticus"). In addition, the researchers will compare the simplified EEG with the conventional EEG in the epilepsy outpatient clinic.

Study Overview

• Status: Recruiting
• Conditions: Status Epilepticus; Altered Mental Status; Non-Convulsive Status Epilepticus
• Intervention / Treatment: Other: point of care EEG

Detailed Description

Non-traumatic, acute central nervous system (CNS) disorders are amongst the most frequent emergencies in childhood. In Switzerland, CNS disorders are the top ranking presentation of critically ill children. Many pediatric neurological emergencies such as coma, acute encephalopathies with impaired consciousness or agitation, or acute focal deficits, are associated with changes of cortical electrical activity detectable by the electroencephalogram (EEG). Of particular concern are status epilepticus (SE) and non-convulsive status epilepticus (NCSE). Previous studies have shown that an EEG can yield important diagnostic information and aid in decision-making. However, conventional EEG-recordings are resource intensive (time, staff), and hardly available outside of regular working hours. Point-of-care EEG (pocEEG) has proven helpful for evaluating impaired consciousness, detecting NCSE, and monitoring therapy in ongoing SE. In a retrospective cohort study from Japan patients with impaired consciousness were diagnosed with non-convulsive seizures in pocEEG, supporting the view that pocEEG can be applied by ED physicians, even in the absence of a neurologist, and can aid the detection and treatment of non-convulsive seizures. Another study, also from Japan, reported that abnormalities were detected in 20% of patients by using pocEEG in an ED setting. The aims of this study are:

• To prospectively assess the feasibility and utility of pocEEG for NCSE detection in children presenting with impaired consciousness in the PED
• To evaluate the interpretation accuracy of pocEEG by pediatric emergency medicine (PEM) providers after a teaching module.
• To compare pocEEG to the "gold standard" of simultaneously recorded conventional EEG in patients undergoing routine cEEG in the epilepsy outpatient clinics.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Leopold Simma, MD; Phone Number: +41442667111; Email: leopold.simma@kispi.uzh.ch

Study Locations

• Switzerland
  • Zürich, Switzerland, 8032
    • Recruiting
    • University Children's Hospital Zurich
    • Contact: Leopold Simma, MD; Phone Number: 0442667111; Email: leopold.simma@kispi.uzh.ch
    • Contact: Georgia Ramantani, MD, PhD; Phone Number: 0442667111; Email: georgia.ramantani@kispi.uzh.ch
    • Principal Investigator: Leopold Simma, MD
    • Principal Investigator: Georgia Ramantani, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 16 years (Child, Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All pediatric patients presenting to the PED or the epilepsy clinic fulfilling the inclusion criteria.

Description

Inclusion Criteria:

General:

PED:

• Pediatric patients with unexplained impaired consciousness, suspicion of NCSE, active SE presenting to the PED
• Informed consent of patient of parents/persons responsible, if possible, otherwise emergency situation procedure (according to national regulations for research in emergency situations)

CLINIC:

• Informed consent as documented by signature
• Pediatric patients undergoing cEEG in the outpatient epilepsy clinics
• Either suspected/ to rule out epilepsy or established diagnosis of epilepsy

Exclusion Criteria:

PED:

• AMS of known etiology or another diagnosis
• Declined informed consent

CLINIC:

• Failure to provide signed informed consent
• Changes in health condition which might interfere with the EEG recording.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pediatric Emergency Department (PED); PED: Patients presenting with unexplained impaired consciousness or active SE: To investigate the role of pocEEG in the PED, we will collect all pocEEG tracings of all children with unexplained impaired consciousness or active SE, for whom written consent has been obtained. We will document the interpretation of the respective pocEEGs by the PEM physician and compare it to the interpretation of the neuropediatrician on call. The research team will also perform a post-hoc analysis.	Other: point of care EEG; For pocEEG, scalp electrodes are applied in five locations.
Epilepsy Clinic; CLINIC: Patients with either suspected epilepsy or established diagnosis of epilepsy will be recruited for simultaneous recording of cEEG and pocEEG in the epilepsy outpatient clinic will help define and investigate the limitations of pocEEG.	Other: point of care EEG; For pocEEG, scalp electrodes are applied in five locations.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants diagnosed with SE, NCSE, and encephalitis by pocEEG	All patients with impaired consciousness presenting to the PED will receive a pocEEG. We analyse the number of patients with SE, NCSE, and encephalitis diagnosed by pocEEG	Baseline
Agreement pocEEG vs. conventional EEG in epilepsy clinic	Agreement of pocEEG and cEEG findings in simultaneous tracings carried out during routine care in the epilepsy clinic.	Baseline

Collaborators and Investigators

• Sponsor: University Children's Hospital, Zurich
• Collaborators: Pediatric Emergency Department, Inselspital Bern, Switzerland; Pediatric Neurology Department, Inselspital Bern, Switzerland (Dr. Sanchez-Albisua)
• Investigators: Principal Investigator: Georgia Ramantani, MD, PhD, University Children's Hospital, Zurich

Publications and helpful links

General Publications

• Simma L, Bauder F, Schmitt-Mechelke T. Feasibility and usefulness of rapid 2-channel-EEG-monitoring (point-of-care EEG) for acute CNS disorders in the paediatric emergency department: an observational study. Emerg Med J. 2021 Dec;38(12):919-922. doi: 10.1136/emermed-2020-209891. Epub 2020 Oct 30.
• Nozawa M, Terashima H, Tsuji S, Kubota M. A Simplified Electroencephalogram Monitoring System in the Emergency Room. Pediatr Emerg Care. 2019 Jul;35(7):487-492. doi: 10.1097/PEC.0000000000001033.
• Yamaguchi H, Nagase H, Nishiyama M, Tokumoto S, Ishida Y, Tomioka K, Tanaka T, Fujita K, Toyoshima D, Nishimura N, Kurosawa H, Nozu K, Maruyama A, Tanaka R, Iijima K. Nonconvulsive Seizure Detection by Reduced-Lead Electroencephalography in Children with Altered Mental Status in the Emergency Department. J Pediatr. 2019 Apr;207:213-219.e3. doi: 10.1016/j.jpeds.2018.11.019. Epub 2018 Dec 7.

Study record dates

Study Major Dates

• Study Start (Actual): August 24, 2022
• Primary Completion (Estimated): August 23, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: June 9, 2022
• First Submitted That Met QC Criteria: June 9, 2022
• First Posted (Actual): June 14, 2022

Study Record Updates

• Last Update Posted (Actual): February 15, 2024
• Last Update Submitted That Met QC Criteria: February 13, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: altered mental status; pediatric emergency medicine; pediatric neurology; status epliepticus; non-convulsive status epilepticus
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Disease Attributes; Seizures; Emergencies; Status Epilepticus
• Other Study ID Numbers: 2022-00842

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No