- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00704470
Performance and Stress During Full Scale Simulator Training
June 25, 2008 updated by: Technische Universität Dresden
Excellence in Performance and Stress Reduction During Two Different Full Scale Simulator Training Courses: A Pilot Study
In Intensive Care Medicine, critical incidents are not rare and may result in fatal outcome.
High fidelity patient simulators are commonly used in training curricula for healthcare professionals especially in anesthesiology, emergency medicine, and intensive care medicine.
Several different course concepts have previously been published.
As we know from recently published data, up to 80% of all critical incidents in the field of medicine are caused by human error.
The authors of the present study aimed to investigate the effects of two different course concepts (one addressing technical skills in intensive care medicine and on addressing non-technical skills) on stress and performance.
Stress and performance are measured in a pre-intervention and a post-intervention testing scenario.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
32
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Dresden, Germany, 01307
- Interdisciplinary Medical Simulation Centre, University Hospital Dresden
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Physician with experience in intensive care medicine.
Exclusion Criteria:
- No experience in intensive care medicine
- previously taken part in simulator training
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 1
Classic one-day simulator training for intensivists.
|
Contains seminars on airway management, general anesthesia, peri-arrest arrhythmias, and advanced life support.
Furthermore, participants train in simulator scenarios.
In the debriefing instructors discuss management of the critical incidents using videotapes of the scenarios.
|
Experimental: 2
Crew resource management training
|
Contains seminars on human error and non-technical skills.
Furthermore, participants train in simulator scenarios.
In the debriefing instructors discuss usage of non-technical skills as well as behaviour of the participants using videotapes of the scenarios.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Performance in simulated emergencies (medical performance and non-technical skills)
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Secondary Outcome Measures
Outcome Measure |
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Stress in simulated emergencies (measured by salivary amylase and cortisol levels)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Michael P Mueller, MD, Director of Simulation Centre, Dept. of Anesthesiology, University Hospital Dresden
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2005
Primary Completion (Actual)
October 1, 2005
Study Completion (Actual)
October 1, 2005
Study Registration Dates
First Submitted
June 24, 2008
First Submitted That Met QC Criteria
June 24, 2008
First Posted (Estimate)
June 25, 2008
Study Record Updates
Last Update Posted (Estimate)
June 27, 2008
Last Update Submitted That Met QC Criteria
June 25, 2008
Last Verified
June 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EK261122004
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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