Performance in Simulated EmergenciesNCT00704470
Performance and Stress During Full Scale Simulator Training
A study testing Medical simulator training and Simulator based crew resource management course in people with Performance in Simulated Emergencies and Stress During Simulator Scenario, run by Technische Universität Dresden at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Performance in Simulated Emergencies, Stress During Simulator Scenario, Behaviour of Physicians in Simulated Emergencies
- What is being tested?
- Medical simulator training and Simulator based crew resource management course
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2005to Oct 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Physician with experience in intensive care medicine.
Who cannot join
- No experience in intensive care medicine
- previously taken part in simulator training
Trial locations and contacts
1 site in 1 country.
Germany1 site
Interdisciplinary Medical Simulation Centre, University Hospital Dresden
Dresden, 01307
About this study
Official title: 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.
- Conditions
- Performance in Simulated Emergencies, Stress During Simulator Scenario, Behaviour of Physicians in Simulated Emergencies
- Being tested
- Medical simulator training, Simulator based crew resource management course
- Keywords
- Patient Simulation, Education, Medical, Continuing, Education, Medical, Graduate, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical simulator trainingOther
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.
Simulator based crew resource management courseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Classic one-day simulator training for intensivists. Receives: Other: Medical simulator training |
| 2 | Experimental | Crew resource management training Receives: Other: Simulator based crew resource management course |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance in simulated emergencies (medical performance and non-technical skills)
Secondary outcomes (1)
Stress in simulated emergencies (measured by salivary amylase and cortisol levels)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2008 (estimated)
- Study startApr 2005
- Primary completionOct 2005
- Study completionOct 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Performance in Simulated EmergenciesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Investigators
- Michael P Mueller, MD, Principal investigator, Director of Simulation Centre, Dept. of Anesthesiology, University Hospital Dresden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00704470
- Sponsor's protocol ID
- EK261122004
- Status last verified
- Jun 2008
- First submitted
- 24 Jun 2008
- Last updated
- 27 Jun 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Muller MP, Hansel M, Stehr SN, Fichtner A, Weber S, Hardt F, Bergmann B, Koch T. Six steps from head to hand: a simulator based transfer oriented psychological training to improve patient safety. Resuscitation. 2007 Apr;73(1):137-43. doi: 10.1016/j.resuscitation.2006.08.011. Epub 2007 Jan 22.
PubMed 17241735
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Excellence in Performance and Stress Reduction During Two Different Full Scale Simulator Training Courses: A Pilot Study
- ClinicalTrials.gov ID
- NCT00704470
- Acronym / sponsor ID
- EK261122004
- Conditions
- Performance in Simulated Emergencies, Stress During Simulator Scenario, Behaviour of Physicians in Simulated Emergencies
- Keywords
- Patient Simulation, Education, Medical, Continuing, Education, Medical, Graduate, Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Study start
- Apr 2005
- Primary completion
- Oct 2005 (actual)
- Study completion
- Oct 2005 (actual)
- First posted
- 25 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Other: Medical simulator trainingClassic one-day simulator training for intensivists. |
| 2 | Experimental | Other: Simulator based crew resource management courseCrew resource management training |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Physician with experience in intensive care medicine.
Key exclusion criteria (2 listed)
- No experience in intensive care medicine
- previously taken part in simulator training
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medical simulator trainingContains 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. | Other | 1 |
| Simulator based crew resource management courseContains 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. | Other | 2 |
Primary outcome
Performance in simulated emergencies (medical performance and non-technical skills)
1 secondary outcome
Stress in simulated emergencies (measured by salivary amylase and cortisol levels)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2008.
- Background: PubMed 17241735Muller MP, Hansel M, Stehr SN, Fichtner A, Weber S, Hardt F, Bergmann B, Koch T. Six steps from head to hand: a simulator based transfer oriented psychological training to improve patient safety. Resuscitation. 2007 Apr;73(1):137-43. doi: 10.1016/j.resuscitation.2006.08.011. Epub 2007 Jan 22.
- Website of Interdisciplinary Medical Simulation CentreLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael P Mueller, MD principal investigator
Director of Simulation Centre, Dept. of Anesthesiology, University Hospital Dresden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medical simulator training and Simulator based crew resource management course in people with Performance in Simulated Emergencies and Stress During Simulator Scenario, run by Technische Universität Dresden at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance in simulated emergencies (medical performance and non-technical skills). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00704470, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2008.