Improving Emergency Management of Status Epilepticus

Not Applicable

Completed

• Conditions: Status Epilepticus
• Interventions: Other: No Pre-briefing; Other: Pre-briefing with the current SE treatment guidelines; Other: Pre-briefing with a consolidated "one page" SE treatment guide

• Registration Number: NCT03883516
• Lead Sponsor: University Hospital, Basel, Switzerland

Brief Summary

In the trial the effectiveness of pre-briefing physicians with the current guideline on Status epilepticus (SE) treatment or a consolidated "one page" guideline regarding quality enhancement of the physician's clinical performances is investigated.

Detailed Description

Status epilepticus (SE) is a life-threatening neurological emergency defined as a state of continuous seizure or multiple seizures without full recovery of sensory, motor and/or cognitive function for at least 30 minutes. To achieve high quality management of SE, the American Epilepsy Society published an evidence-based guideline for the treatment of SE, which serves as reference for most national guidelines, but analyses regarding practicability, strict adherence, correct translation into clinical practice, and identification of recommended treatment steps at risk of being modified or missed are lacking. Simulator-based studies offer a platform for the design of standardized clinical scenarios that enable detailed investigations regarding the effect of the implementation and practicability of treatment guidelines.

This randomized controlled intervention study performed at the simulation center of the medical intensive care units (ICUs) at the University Hospital Basel is to investigate the effectiveness of pre-briefing physicians with both the current guideline on Status epilepticus (SE) treatment or a consolidated "one page" guideline regarding quality enhancement of the physicians' clinical performances..

Physicians from different medical specialties and with different duration of clinical experience will be enrolled. Participants will be randomly assigned to one of the following three pre-briefing groups: (1) no pre-briefing prior to the simulation training; (2) pre-briefing with the current SE treatment guidelines; (3) pre-briefing with the consolidated "one page" SE treatment guideline.

Study Timeline

• Study First Submitted: 2019-03-12
• Study First Submitted QC: 2019-03-18
• Study First Posted: 2019-03-21
• Study Start: 2020-12-01
• Primary Completion: 2024-07-15
• Study Completion: 2024-07-15
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-07
• Last Update Posted: 2025-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 124

Inclusion Criteria

• Physicians from different medical specialties working at the University Hospital Basel

Exclusion Criteria

• None

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No pre-briefing prior to the simulation training	No Pre-briefing	No pre-briefing prior to the simulation training
Pre-briefing with the current SE treatment guidelines	Pre-briefing with the current SE treatment guidelines	pre-briefing with the current SE treatment Guidelines published by the American Epilepsy Society
pre- briefing with consolidated SE treatment guideline	Pre-briefing with a consolidated "one page" SE treatment guide	pre-briefing with the consolidated "one page" SE treatment guideline

Primary Outcome Measures

Name	Time	Method
Time to SE recognition (minutes)	from start of simulation training until recognition of seizure and/or SE (max. 20 minutes)	time to recognition of seizure and/or SE

Secondary Outcome Measures

Name	Time	Method
administration of anti-seizure medication	within the first 20 minutes after beginning of the simulation training	time of administration of anti-seizure medication (minutes)
quantification of Glasgow Coma Score (GCS)	within the first 20 minutes after beginning of the simulation training	GCS is a neurological scale recording the state of a person's consciousness ; The scale is composed of three tests: eye, verbal and motor responses. The three values separately as well as their sum are considered. The lowest possible GCS (graded 1 in each element) is 3 (deep coma or death), while the highest is 15 (fully awake person).
dose of anti-seizure medication	within the first 20 minutes after beginning of the simulation training	dose of anti-seizure medication (mg)
time to correct airways protection	from start of simulation training until correct airways protection (max. 20 minutes)	time to correct airways protection (minutes)

Trial Locations

Locations (1)

Clinic for Intensive Care Medicine, University Hospital Basel; 🇨🇭 Basel, Switzerland