Improving Emergency Management of Status Epilepticus

Status Epilepticus Clinical Trial

— SESIM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03883516
• Other study ID #: Requ_2019-00168; me19Sutter3
• Status: Recruiting
• Phase: N/A
• Start date: September 30, 2019
• Est. completion date: December 2024

Study information

• Verified date: April 2024
• Source: University Hospital, Basel, Switzerland
• Contact: Raoul Sutter, PD Dr. MD
• Phone: +41 61 328 79 28
• Email: raoul.sutter[@]usb.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Emergencies
• Status Epilepticus

Intervention

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
• 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
• No Pre-briefing
no instruction of the study participants prior to the simulation training

Locations

Country	Name	City	State
Switzerland	Clinic for Intensive Care Medicine, University Hospital Basel	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	administration of anti-seizure medication	time of administration of anti-seizure medication (minutes)	within the first 20 minutes after beginning of the simulation training
Secondary	dose of anti-seizure medication	dose of anti-seizure medication (mg)	within the first 20 minutes after beginning of the simulation training
Secondary	time to correct airways protection	time to correct airways protection (minutes)	from start of simulation training until correct airways protection (max. 20 minutes)
Secondary	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