Point-of-care EEG in the Pediatric Emergency Department

Sponsor
University Children's Hospital, Zurich (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05418634
Collaborator
(none)
120
1
2
24
5

Study Details

Study Description

Brief Summary

We are investigating the use of a simplified electroencephalogram (point-of-care EEG) in the pediatric emergency department for children with impaired consciousness or an epileptic seizure. In addition, we will compare the simplified EEG with the conventional EEG in the epilepsy outpatient clinic.

Condition or Disease Intervention/Treatment Phase
  • Other: point of care EEG
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
The Role of Point-of-care EEG in the Pediatric Emergency Department
Anticipated Study Start Date :
Jul 1, 2022
Anticipated Primary Completion Date :
Jul 1, 2024
Anticipated Study Completion Date :
Jul 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Other: 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.

Other: 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.

Outcome Measures

Primary Outcome Measures

  1. Number of participants diagnosed with SE, NCSE, and encephalitis by pocEEG [Baseline]

    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

  2. Agreement pocEEG vs. conventional EEG in epilepsy clinic [Baseline]

    Agreement of pocEEG and cEEG findings in simultaneous tracings carried out during routine care in the epilepsy clinic.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Children's Hospital Zurich Zürich Switzerland 8032

Sponsors and Collaborators

  • University Children's Hospital, Zurich

Investigators

  • Principal Investigator: Georgia Ramantani, MD, PhD, University Children's Hospital, Zurich

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Leopold Simma, PEM Attending, University Children's Hospital, Zurich
ClinicalTrials.gov Identifier:
NCT05418634
Other Study ID Numbers:
  • 2022-00842
First Posted:
Jun 14, 2022
Last Update Posted:
Jun 14, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Leopold Simma, PEM Attending, University Children's Hospital, Zurich
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 14, 2022