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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00704470
Other study ID # EK261122004
Secondary ID
Status Completed
Phase N/A
First received June 24, 2008
Last updated June 25, 2008
Start date April 2005
Est. completion date October 2005

Study information

Verified date June 2008
Source Technische Universität Dresden
Contact n/a
Is FDA regulated No
Health authority Germany: University of Technology, Dresden
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 32
Est. completion date October 2005
Est. primary completion date October 2005
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Physician with experience in intensive care medicine.

Exclusion Criteria:

- No experience in intensive care medicine

- previously taken part in simulator training

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)


Related Conditions & MeSH terms


Intervention

Other:
Medical simulator training
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 course
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.

Locations

Country Name City State
Germany Interdisciplinary Medical Simulation Centre, University Hospital Dresden Dresden

Sponsors (1)

Lead Sponsor Collaborator
Technische Universität Dresden

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Müller MP, Hänsel 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. Epub 2007 Jan 22. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Performance in simulated emergencies (medical performance and non-technical skills) Yes
Secondary Stress in simulated emergencies (measured by salivary amylase and cortisol levels) No