Trial document





This trial has been registered retrospectively.
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  DRKS00010735

Trial Description

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Title

Usability of modern monitor defibrillators

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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Brief Summary in Scientific Language

The lifesaving effectiveness of defibrillation as primary therapy for sudden cardiac arrest due to ventricular fibrillation is without question. A simple and intuitive design leads to a significant increase in patient safety.In this regard a manual defibrillator which is intuitively to operate represents a key component for efficient and safe patient treatment.
Therefore we want to investigate the usability of four modern manual defibrillators with naïve operators. For that purpose, successful task execution, requested numbers of support and processing times are measured while the operators rendera series of tasks, representing typical operator-device interactions during cardiac arrest. Additionally, while performing the tasks, the operators’ visual focus will be assessed via eye-tracking and the users’ perception of usability will be evaluated by a standardized usability questionnaire thereafter. Additionally we will evaluate the stress-level of the subject just after completing the tasks by self-report.

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Organizational Data

  •   DRKS00010735
  •   2016/06/29
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  •   yes
  •   Approved
  •   17/16, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

  •   U1111-1184-6348 
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Health Condition or Problem studied

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

  •   Operators have to perform several tasks on a defibrillator. Four devices are presented in randomized order. Measurement of processing times and frequencies of assistances are recorded. After execution of all tasks operators are asked to fill out a usability questionnaire
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

System usability Scale (SUS)

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Secondary Outcome

successful task execution
number of requested support
processing times
visual focus of subject
requested numbers of support
stress level of subject

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

  •   Actual
  •   2016/02/15
  •   21
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   65   Years
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Additional Inclusion Criteria

naive subjects, basic knowledge of advanced cardiac life support, no recent experience with one of the tested defibrillators

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Exclusion Criteria

Operators are not included when they’ve indicated last night’s sleep less than 5 hours, medication with sedatives and alcohol or drug uptake within the last 12 hours. Moreover, the operators’ experience or habituation with one of the tested defibrillators is an exclusion criterium.

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Addresses

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    • Universitätsklinikum Freiburg
    • Hugstetter Strasse 49
    • 79095  Freiburg
    • Germany
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    • Klinik für Anästhesiologie und IntensivmedizinUNIVERSITÄTSKLINIKUM FREIBURG
    • Mr.  Dr. med.  Axel  Schmutz 
    • Hugstetter Strasse 55
    • 79095  Freiburg
    • Germany
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    • Klinik für Anästhesiologie und IntensivmedizinUNIVERSITÄTSKLINIKUM FREIBURG
    • Mr.  Dr. med.  Axel  Schmutz 
    • Hugstetter Strasse 55
    • 79095  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Freiburg
    • Hugstetter Strasse 49
    • 79095  Freiburg
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2016/04/29
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Trial Publications, Results and other Documents

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