Clinical trial NCT03883516: Improving Emergency Management of Status Epilepticus
Official title: Improving Emergency Management of Status Epilepticus - a High-fidelity Simulator-based Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Status Epilepticus
Keywords: guideline for the treatment of Status Epilepticus
antiseizure drugs (ASDs)
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2019-03-21
Enrollment: 124
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* None

Primary outcomes:
measure: Time to SE recognition (minutes)
timeFrame: from start of simulation training until recognition of seizure and/or SE (max. 20 minutes)
Secondary outcomes:
measure: administration of anti-seizure medication
timeFrame: within the first 20 minutes after beginning of the simulation training
measure: dose of anti-seizure medication
timeFrame: within the first 20 minutes after beginning of the simulation training
measure: time to correct airways protection
timeFrame: from start of simulation training until correct airways protection (max. 20 minutes)
measure: quantification of Glasgow Coma Score (GCS)
timeFrame: within the first 20 minutes after beginning of the simulation training
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Clinic for Intensive Care Medicine, University Hospital Basel
Study officials:
affiliation: Clinic for Intensive Care Medicine, University Hospital Basel
name: Raoul Sutter, PD Dr. MD
role: PRINCIPAL_INVESTIGATOR
References: