Trial document





This trial has been registered retrospectively.
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  DRKS00004516

Trial Description

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Title

Anticipated charging for defibrillation

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

In cases of cardiac arrest – among others -two things are crucial for survival: high-quality CPR (cardiopulmonary resuscitation) with minimal interruptions an (if indicated) defibrillation as soon as possible. CPR interruptions should be under five seconds else mortality increases significantly – that is also the case for defibrillation interruptions. So far rhythm was checked and depending on the rhythm charged and defibrillated. There is evidence that charging before each rhythm control (during chest compression) and then depending on the rhythm either defibrillation or rejection of energy right after rhythm analysis decreases the times significantly and relevantly. This study should confirm these findings and examine whether the methods differ regarding safety.

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Brief Summary in Scientific Language

The current Resuscitation Guidelines 2010 demand minimizing the no-flow time in order to reduce mortality.
Every five-second chest compression pause increases mortality significantly. This also applies for rhythm analysis and defibrillation pauses (if indicated).
Usually a short pause for rhythm analysis
is followed by a prompt resumption of chest compression.
For VF / pVT the defibrillator is charged during continuous chest compressions. During another chest compression pause defibrillation is conducted.
An alternative (anticipatory) method has the defibrillator charged prior to rhythm analysis regardless of given rhythm. Afterwards, chest compression pauses for rhythm analysis. For VF / pVT defibrillation follows right after analysis and is thus followed by chest compression.
A retrospective study by Edelson et al. in 2010 and a small prospective manikin study by Thim et al. in 2012 were able to show a significantly shorter no-flow time for the alternative, anticipatory method of charging. This prospective manikin study is supposed to confirm these findings. Moreover, we will examine if both methods differ regarding safety. The participants are assigned randomly either to the anticipatory method or classic method.

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Organizational Data

  •   DRKS00004516
  •   2012/12/18
  •   [---]*
  •   yes
  •   Approved
  •   427-12, 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
  •   I49.0 -  Ventricular fibrillation and flutter
  •   no-flow-time
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Interventions/Observational Groups

  •   2010 ERC- Guideline standard sequence of rhythm analysis and defibrillation:
    Pause of chest compressions for rhythm analysis if indicated resumption of chest compressions while charging followed by another pause of chest compressions for shock delivery.
  •   Anticipatory sequence of rhythm analysis and defibrillation:
    Charging during chest compressions prior to every rhythm analysis, pause of chest compressions for rhythm analysis, if indicated immediate shock delivery (or disarm defibrillator if shock is not indicated), resumption of chest compressions
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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

Time without chest compressions (no-flow time) - computer evaluation, safety - video surveillance checklist

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Secondary Outcome

Quality of chest compressions, confidence in analysis ECG-rhythms during an examination 1-4 weeks after learning the method using pre-defined checklists and video-recordings

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2012/11/09
  •   200
  •   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.

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Addresses

  • start of 1:1-Block address primary-sponsor
    • 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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    • 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, Klinikum der Universität München
    • Schillerstr. 53
    • 80633  München
    • Germany
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Status

  •   Recruiting complete, follow-up continuing
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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.