Trial document




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  DRKS00012885

Trial Description

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Title

Quality of cardiopulmonary resuscitation (CPR) during transport from an upper floor using different routes od evacuation and different methods of CPR

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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

Aim of the study is to investigate the quality of cardiopulmonary resuscitation (CPR) during transport from an upper floor using different evacuation routes and different methods of CPR. This should make it possible to deduce an optimal tactic for evacuation during ongoing CPR. Transport to the hospital during ongoing CPR is rare in the German physician staffed Emergency Medical Services (EMS) but in some cases warranted to transport the patient to a hospital capable of causal treatment of potentially reversible causes of cardiac arrest. Transport with ongoing CPR however, implies significant difficulties and risks: The quality of CPR can be seriously impaired and risk of injury to the EMS-personnel is high. Therefore, the guidelines of the European Resuscitation Council mention the use of mechanical CPR-devices in those special circumstances. We are simulating a scenario, in which a mannequin, which records depth and frequency of chest compressions, is to be transported under CPR from a fifth floor by EMS-personnel. Three routes of evacuation are tested: 1) lift, with the moveable stretcher of the mobile intensive care unit 2) staircase, on a spineboard 3) turntable ladder. Each route is tested either using manual CPR or mechanical CPR (corpuls CPR device). Endpoints are depth and frequency of compression and leaning on the chest between compressions. Testing of “harder” endpoints, such as survival rates or neurological outcome, does not appear feasible, as such situations occur very rarely, thus not permitting recruitment of a sufficient number of patients in due time.

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Organizational Data

  •   DRKS00012885
  •   2017/08/17
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  •   yes
  •   Approved
  •   17-301, Ethik-Kommission der Medizinischen Fakultät der Universität zu Köln
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Secondary IDs

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Health Condition or Problem studied

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

  •   Transport of a mannequin from the fifth floor to a mobile intensive care unit via a turntable ladder on a stretcher swivel support during manual chest compresion.
  •   Transport of a mannequin from the fifth floor to a mobile intensive care unit via a turntable ladder on a stretcher swivel support during mechnical chest compresion (corpuls CPR, manufacturer: GS Elektromedizinische Geräte G Stemple GmbH).
  •   Transport of a mannequin from the fifth floor to a mobile intensive care unit via a lift accessible with a moveable stretcher during Manual chest compresion
  •   Transport of a mannequin from the fifth floor to a mobile intensive care unit via a lift accessible with a moveable stretcher during mechnical chest compresion (corpuls CPR, manufacturer: GS Elektromedizinische Geräte G Stemple GmbH).
  •   Transport of a mannequin from the fifth floor to a mobile intensive care unit on a spineboard via the staircase during manual chest compresion
  •   Transport of a mannequin from the fifth floor to a mobile intensive care unit on a spineboard via the staircase during mechnical chest compresion (corpuls CPR, manufacturer: GS Elektromedizinische Geräte G Stemple GmbH).
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

Primary endpoints are quality measures of CPR (cardiopulmonary resuscitation) as registered by the mannequin: Depth and frequency of chest compressions, incomplete release between compression as well as duration of transport from lifting the mannequin from the floor to arrival at a mobile intensive care unit parked in front of the building

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Secondary Outcome

Secondary outcomes are safety outcomes: Injury/accidents to the personnel, disconnection of Ventilator/endotracheal tube, intravenous line or ECG-/defibrillation electrodes or dislocation of the CPR-device observed during transport.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2017/10/26
  •   40
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Consent to participate
physical and mental Fitness to particpate
traning as medical doctor, or paramedic (Notfallsanitäter, Rettungsassistent or Rettungssanitäter in the German System)

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Exclusion Criteria

lack of consent,
lack of physical or mental fitness
lack of appropriate training

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Addresses

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    • Feuerwehr der Stadt Brühl
    • Rheinstraße 107
    • 50321  Brühl
    • Germany
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    • Feuerwehr der Stadt Brühl
    • Rheinstraße 107
    • 50321  Brühl
    • Germany
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    • Klinik für Anästhesiologie und Operative IntensivmedizinUniversitätsklinikum Köln
    • Mr.  Dr. med.  Hendrik   Drinhaus 
    • Kerpener Str. 62
    • 50924  Köln
    • Germany
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    • Klinik für Anästhesiologie und Operative IntensivmedizinUniversitätsklinikum Köln (AöR)
    • Mr.  Dr. med.  Hendrik  Drinhaus 
    • Kerpener Str. 62
    • 50937  Köln
    • Germany
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Sources of Monetary or Material Support

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    • Feuerwehr der Stadt Brühl
    • Rheinstraße 107
    • 50321  Brühl
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2018/10/26
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Trial Publications, Results and other Documents

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