Trial document




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  DRKS00006093

Trial Description

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Title

Direct vs indirect Feedback during CPR Training

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

High quality cardiopulmonary resuscitation (CPR) is essential for good results after resuscitation. This is achieved by training. Feedback and feedback tools are explicitly recommended in the guidelines but are rare in real life situations and are not likely to be the standard in non-professional resuscitation in the future. Thus the question arises how the training should be formulated in order to achieve the best real-life performance. The question is whether direct, visual feedback during training is enough to transfer this into the real-life situation.
The study aims at researching the influence of direct feedback (by looking at the manikin screen), or indirect feedback (with real time feedback from an attending audience without checking the screen) on later CPR without feedback (here the practical OSCE exams) since this is nearly never given in real life situations.

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Brief Summary in Scientific Language

The study intends to find out which feedback method during CPR training has a higher retention regarding future use without feedback since this is nearly never given in real life situations.
The student usually has no problem reaching good CPR quality once they see the parameters themselves (depth, decompression…). The visuomotoric feedback-loop works. Thus it is supposed that the students with direct feedback during the practical training test better (study-theoretic background: motoric studying).
Yet how is the performance in reality respectively in the OSCE exams when there is no direct feedback? Is there an advantage for the students who already had indirect but qualified feedback from the audience during practice as opposed to the students who could check the screen? They had from the beginning only their own judgment in estimating the efficiency of their performance.

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Organizational Data

  •   DRKS00006093
  •   2014/04/28
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  •   yes
  •   Approved
  •   105-14, 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 -  Cardiac arrest
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Interventions/Observational Groups

  •   Group with direct feedback – students see the manikin screen in real time
  •   Group with indirect feedback – only the audience sees the manikin screen but give feedback on to the student in real time
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control
  •   Treatment
  •   Parallel
  •   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
  •   2014/05/02
  •   240
  •   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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    • Institut für Notfallmedizin und Medizinmanagement (INM), Klinikum der Universität München
    • Mr.  Dr. med.  Oliver  Meyer 
    • Schillerstr. 53
    • 80336  München
    • Germany
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    • Institut für Notfallmedizin und Medizinmanagement (INM), Klinikum der Universität München
    • 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
  •   2014/07/25
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.