Trial document




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  DRKS00004944

Trial Description

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Title

ALS-rules

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Sudden cardiac death is the main cause of death in Germany and Europe. A relevant part of patients can be rescued by basic and advanced life saving measures of high quality. These extended measures are explained by the European Resuscitation Councils (ERC) guidelines in detail, which are based on an international consensus (ILCOR).
That study analyzes if an additional short and concise presentation of the essential recommendations (group 2) can improve the performance of medical students within a simulated resuscitation case study considerably, compared to traditional training (group 2).

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Brief Summary in Scientific Language

If it is assumed that following the resuscitation guidelines has a positive impact on the result. It will be examined if the additionally summarized ALS-rules and the tabulated presentation make the test persons (medical students in a practical training in emergency medicine) set up a more efficient conceptual model than in former trainings, so that performance in a simulated reanimation case study within an OSCE examination will be improved.

Due to organisational reasons first group 1 without intervention will be examined, followed by groups 2, 3 and 4 with different interventions.

That study will establish the hypothesis that our ALS-rules and tabulated examples of use can improve the learning and understanding of individual parts and also enhance the ability to prioritize in case of reanimation. According to that a null hypothesis can be established that there is no difference within the performance of simulated case examples by using ALS rules and tabulated examples of use.

The research question is:
Do ALS rules and tabulated case examples - being implemented in addition to the already existing lecture notes of emergency medicine, in addition to the tutorial and in addition to the practical training - improve the performance of medical students of the second and third semester in a simulated reanimation case study (performed at a simulation manikin)?

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Organizational Data

  •   DRKS00004944
  •   2013/05/02
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  •   yes
  •   Approved
  •   177-13, Ethik-Kommission der Medizinischen Fakultät der Ludwig-Maximilians-Universität München
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Secondary IDs

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Health Condition or Problem studied

  •   I46.9 -  Cardiac arrest, unspecified
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Interventions/Observational Groups

  •   Group without intervention – conventional training for medical students with a cardiac arrest scenario in an OSCE (Objective Structured Clinical Examinations)
  •   Group with intervention (ALS-rules) - conventional training for medical students with additional concise abstract using keywords in the educational script and finally a cardiac arrest scenario in an OSCE
  •   Group with intervention (ALS-rules) - conventional training for medical students with additional charts in the educational script and finally a cardiac arrest scenario in an OSCE
  •   Group with intervention (ALS-rules) - conventional training for medical students with additional concise abstract using keywords and charts in the educational script and finally a cardiac arrest scenario in an OSCE
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Characteristics

  •   Interventional
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  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Active control
  •   Treatment
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

cumulative score of the examination performance in a simulated reanimation case study (in the context of an OSCE examination)

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Secondary Outcome

questionnaire with demographic specifications (for the identification of potential confounders)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2013/11/08
  •   231
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Legal age: at least 18 years of age,
Informed consent and capacity of consent,
student of human medicine at the medical faculty of the Ludwig- Maximilians- Universität München,
participation in practical training of emergency medicine (Block AINS), full legal competence,
full knowledge of German language,
written consent of participation in the study after previous clarification; no exclusion criteria

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Exclusion Criteria

Lack of informed consent and capacity of consent, lack of legal age, communication in German language not possible, lack of written agreement that permits participation in the study, lack of clarification,
pregnancy, physical or mental impairments / disabilities that contradict participation,
physical or mental impairments / disabilities that exclude performing resuscitation or at least significantly interfere with their opportunities for participating,
mental deficiencies or disabilities that render the purpose of the study or performed methods impossible. Lack of at least one criterion for inclusion

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Addresses

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    • Institut für Notfallmedizin und Medizinmanagement (INM), Klinikum der universität München
    • Schillerstr. 53
    • 80633  München
    • Germany
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    • Klinikum der Universität München Institut für Notfallmedizin und Medizinmanagement Bereich Medizin
    • Mr.  Dr. med.  Oliver  Meyer 
    • Schillerstr. 53
    • 80336  München
    • Germany
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    • Klinikum der Universität München Institut für Notfallmedizin und Medizinmanagement Bereich Medizin
    • Mr.  Dr. med.  Oliver  Meyer 
    • Schillerstr. 53
    • 80336  München
    • Germany
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Sources of Monetary or Material Support

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    • Institut für Notfallmedizin und Medizinmanagement (INM), Klinikum der Universität München
    • Schillerstr. 53
    • 80633  München
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2014/03/31
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Trial Publications, Results and other Documents

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