Improving Emergency Management of Status Epilepticus (SESIM)

Improving Emergency Management of Status Epilepticus - a High-fidelity Simulator-based Randomized Controlled Trial

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stephan Marsch, Prof. Dr. MD
• Study Contact Backup: Name: Raoul Sutter, PD Dr. MD; Phone Number: +41 61 328 79 28; Email: raoul.sutter@usb.ch

Study Locations

• Switzerland
  • Basel, Switzerland, 4031
    • Recruiting
    • Clinic for Intensive Care Medicine, University Hospital Basel
    • Contact: Raoul Sutter, PD Dr. MD; Phone Number: +41 61 265 25 25; Email: raoul.sutter@usb.ch
    • Sub-Investigator: Stephan Marsch, Prof. Dr. MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: No pre-briefing prior to the simulation training	Other: No Pre-briefing; no instruction of the study participants prior to the simulation training
Active Comparator: Pre-briefing with the current SE treatment guidelines; pre-briefing with the current SE treatment Guidelines published by the American Epilepsy Society	Other: Pre-briefing with the current SE treatment guidelines; instruction of the study participants according to the evidence-based guideline for the treatment of SE published by the American Epilepsy Society prior to the simulation training
Active Comparator: pre- briefing with consolidated SE treatment guideline; pre-briefing with the consolidated "one page" SE treatment guideline	Other: Pre-briefing with a consolidated "one page" SE treatment guide; instruction of the study participants with a consolidated "one page" SE treatment guide prior to the simulation training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to SE recognition (minutes)	time to recognition of seizure and/or SE	from start of simulation training until recognition of seizure and/or SE (max. 20 minutes)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
administration of anti-seizure medication	time of administration of anti-seizure medication (minutes)	within the first 20 minutes after beginning of the simulation training
dose of anti-seizure medication	dose of anti-seizure medication (mg)	within the first 20 minutes after beginning of the simulation training
time to correct airways protection	time to correct airways protection (minutes)	from start of simulation training until correct airways protection (max. 20 minutes)
quantification of Glasgow Coma Score (GCS)	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).	within the first 20 minutes after beginning of the simulation training

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Investigators: Principal Investigator: Raoul Sutter, PD Dr. MD, Clinic for Intensive Care Medicine, University Hospital Basel

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2019
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: March 12, 2019
• First Submitted That Met QC Criteria: March 18, 2019
• First Posted (Actual): March 21, 2019

Study Record Updates

• Last Update Posted (Actual): April 22, 2024
• Last Update Submitted That Met QC Criteria: April 19, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: guideline for the treatment of Status Epilepticus; antiseizure drugs (ASDs)
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Disease Attributes; Seizures; Emergencies; Status Epilepticus
• Other Study ID Numbers: Requ_2019-00168; me19Sutter3

Drug and device information, study documents

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