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Improving Emergency Management of Status Epilepticus (SESIM)

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ClinicalTrials.gov Identifier: NCT03883516
Recruitment Status : Recruiting
First Posted : March 21, 2019
Last Update Posted : November 2, 2021
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Study Description
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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.

Condition or disease Intervention/treatment Phase
Status Epilepticus Other: Pre-briefing with the current SE treatment guidelines Other: Pre-briefing with a consolidated "one page" SE treatment guide Other: No Pre-briefing Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
Official Title: Improving Emergency Management of Status Epilepticus - a High-fidelity Simulator-based Randomized Controlled Trial
Actual Study Start Date : September 30, 2019
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: No pre-briefing prior to the simulation training
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


Outcome Measures
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Primary Outcome Measures :
  1. Time to SE recognition (minutes) [ Time Frame: 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 :
  1. administration of anti-seizure medication [ Time Frame: within the first 20 minutes after beginning of the simulation training ]
    time of administration of anti-seizure medication (minutes)

  2. dose of anti-seizure medication [ Time Frame: within the first 20 minutes after beginning of the simulation training ]
    dose of anti-seizure medication (mg)

  3. time to correct airways protection [ Time Frame: from start of simulation training until correct airways protection (max. 20 minutes) ]
    time to correct airways protection (minutes)

  4. quantification of Glasgow Coma Score (GCS) [ Time Frame: 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).


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • None
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03883516


Contacts
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Contact: Raoul Sutter, PD Dr. MD +41 61 328 79 28 raoul.sutter@usb.ch
Contact: Stephan Marsch, Prof. Dr. MD

Locations
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Switzerland
Clinic for Intensive Care Medicine, University Hospital Basel Recruiting
Basel, Switzerland, 4031
Contact: Raoul Sutter, PD Dr. MD    +41 61 265 25 25    raoul.sutter@usb.ch   
Sub-Investigator: Stephan Marsch, Prof. Dr. MD         
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
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Principal Investigator: Raoul Sutter, PD Dr. MD Clinic for Intensive Care Medicine, University Hospital Basel
More Information
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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT03883516    
Other Study ID Numbers: Requ_2019-00168; me19Sutter3
First Posted: March 21, 2019    Key Record Dates
Last Update Posted: November 2, 2021
Last Verified: November 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Basel, Switzerland:
guideline for the treatment of Status Epilepticus
antiseizure drugs (ASDs)
Additional relevant MeSH terms:
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Status Epilepticus
Emergencies
Disease Attributes
Pathologic Processes
 Seizures
Neurologic Manifestations
Nervous System Diseases