NCT05418634

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 9, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 14, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

August 24, 2022

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 23, 2025

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 24, 2025

Completed
Last Updated

September 4, 2025

Status Verified

August 1, 2025

Enrollment Period

3 years

First QC Date

June 9, 2022

Last Update Submit

August 27, 2025

Conditions

Keywords

pediatric emergency medicinepediatric neurologystatus epliepticusnon-convulsive status epilepticusaltered mental status

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

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

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

Interventions

For pocEEG, scalp electrodes are applied in five locations.

Epilepsy ClinicPediatric Emergency Department (PED)

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Children's Hospital Zurich

Zurich, 8032, Switzerland

Location

Related Publications (4)

  • Simma L, Romano F, Schmidt S, Ramantani G, Bolsterli BK. Integrating Neuromonitoring in Pediatric Emergency Medicine: Exploring Two Options for Point-of-Care Electroencephalogram (pocEEG) via Patient Monitors-A Technical Note. J Pers Med. 2023 Sep 20;13(9):1411. doi: 10.3390/jpm13091411.

    PMID: 37763178BACKGROUND
  • 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.

    PMID: 33127740BACKGROUND
  • 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.

    PMID: 28072672BACKGROUND
  • 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.

    PMID: 30528574BACKGROUND

MeSH Terms

Conditions

Status Epilepticus

Condition Hierarchy (Ancestors)

SeizuresNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Georgia Ramantani, MD, PhD

    University Children's Hospital, Zurich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PEM Attending

Study Record Dates

First Submitted

June 9, 2022

First Posted

June 14, 2022

Study Start

August 24, 2022

Primary Completion

August 23, 2025

Study Completion

August 24, 2025

Last Updated

September 4, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations