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Improving Emergency Management of Status Epilepticus (SESIM)

Primary Purpose

Status Epilepticus

Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Pre-briefing with the current SE treatment guidelines
Pre-briefing with a consolidated "one page" SE treatment guide
No Pre-briefing
Sponsored by
University Hospital, Basel, Switzerland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Status Epilepticus focused on measuring guideline for the treatment of Status Epilepticus, antiseizure drugs (ASDs)

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Sites / Locations

  • Clinic for Intensive Care Medicine, University Hospital BaselRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

No pre-briefing prior to the simulation training

Pre-briefing with the current SE treatment guidelines

pre- briefing with consolidated SE treatment guideline

Arm Description

No pre-briefing prior to the simulation training

pre-briefing with the current SE treatment Guidelines published by the American Epilepsy Society

pre-briefing with the consolidated "one page" SE treatment guideline

Outcomes

Primary Outcome Measures

Time to SE recognition (minutes)
time to recognition of seizure and/or SE

Secondary Outcome Measures

administration of anti-seizure medication
time of administration of anti-seizure medication (minutes)
dose of anti-seizure medication
dose of anti-seizure medication (mg)
time to correct airways protection
time to correct airways protection (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).

Full Information

First Posted
March 12, 2019
Last Updated
November 1, 2021
Sponsor
University Hospital, Basel, Switzerland
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1. Study Identification

Unique Protocol Identification Number
NCT03883516
Brief Title
Improving Emergency Management of Status Epilepticus
Acronym
SESIM
Official Title
Improving Emergency Management of Status Epilepticus - a High-fidelity Simulator-based Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
September 30, 2019 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Basel, Switzerland

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Status Epilepticus
Keywords
guideline for the treatment of Status Epilepticus, antiseizure drugs (ASDs)

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
No pre-briefing prior to the simulation training
Arm Type
Placebo Comparator
Arm Description
No pre-briefing prior to the simulation training
Arm Title
Pre-briefing with the current SE treatment guidelines
Arm Type
Active Comparator
Arm Description
pre-briefing with the current SE treatment Guidelines published by the American Epilepsy Society
Arm Title
pre- briefing with consolidated SE treatment guideline
Arm Type
Active Comparator
Arm Description
pre-briefing with the consolidated "one page" SE treatment guideline
Intervention Type
Other
Intervention Name(s)
Pre-briefing with the current SE treatment guidelines
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Pre-briefing with a consolidated "one page" SE treatment guide
Intervention Description
instruction of the study participants with a consolidated "one page" SE treatment guide prior to the simulation training
Intervention Type
Other
Intervention Name(s)
No Pre-briefing
Intervention Description
no instruction of the study participants prior to the simulation training
Primary Outcome Measure Information:
Title
Time to SE recognition (minutes)
Description
time to recognition of seizure and/or SE
Time Frame
from start of simulation training until recognition of seizure and/or SE (max. 20 minutes)
Secondary Outcome Measure Information:
Title
administration of anti-seizure medication
Description
time of administration of anti-seizure medication (minutes)
Time Frame
within the first 20 minutes after beginning of the simulation training
Title
dose of anti-seizure medication
Description
dose of anti-seizure medication (mg)
Time Frame
within the first 20 minutes after beginning of the simulation training
Title
time to correct airways protection
Description
time to correct airways protection (minutes)
Time Frame
from start of simulation training until correct airways protection (max. 20 minutes)
Title
quantification of Glasgow Coma Score (GCS)
Description
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).
Time Frame
within the first 20 minutes after beginning of the simulation training

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Physicians from different medical specialties working at the University Hospital Basel Exclusion Criteria: None
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Raoul Sutter, PD Dr. MD
Phone
+41 61 328 79 28
Email
raoul.sutter@usb.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Stephan Marsch, Prof. Dr. MD
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raoul Sutter, PD Dr. MD
Organizational Affiliation
Clinic for Intensive Care Medicine, University Hospital Basel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinic for Intensive Care Medicine, University Hospital Basel
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raoul Sutter, PD Dr. MD
Phone
+41 61 265 25 25
Email
raoul.sutter@usb.ch
First Name & Middle Initial & Last Name & Degree
Stephan Marsch, Prof. Dr. MD

12. IPD Sharing Statement

Learn more about this trial

Improving Emergency Management of Status Epilepticus

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