Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00020819

Trial Description

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Title

Comparing Observational Multicentre Prospective Registry Study on Resuscitation

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Trial Acronym

COMPRESS

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Mechanical chest compression devices are well established tools for the treatment of out-of-hospital and in-hospital cardiac arrest. The corpuls cpr developed by GS Elektromedizinische Geräte G. Stemple GmbH represents a new generation of mechanical chest compression devices. The COMPRESS study shall observe the usage of the established device. The study examines the chest compression, the ventilation parameters and resuscitation related injuries. The aim of the study is to validate the safety and performance of the device and the safety of its usage for the patient.
Over a time period of three years, routine resuscitation data are collected within several emergency medical services based on the German Resuscitation Registry database for this multicenter observational study.

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Brief Summary in Scientific Language

Today mechanical chest compression devices are a well-established alternative to manual chest compressions. They are recommended especially within ongoing cardiopulmonary resuscitation (CPR) during transport or special interventions (e.g. coronary angiography). The corpuls cpr developed by GS Elektromedizinische Geräte G. Stemple GmbH represents a new generation of mechanical chest compression devices. The study examines the chest compression (e.g. no-flow-time, pauses, compression depth, compression frequency), the ventilation parameters and resuscitation related injuries. The aim of the study is to validate the safety and performance of the device and the safety of its usage for the patient.
Over a time period of three years, routine resuscitation data are collected within several emergency medical services based on the German Resuscitation Registry database for this multicenter observational study. Within the study period yearly interim analyses will be performed.

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Do you plan to share individual participant data with other researchers?

No

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Description IPD sharing plan:

[---]*

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Organizational Data

  •   DRKS00020819
  •   2020/07/31
  •   [---]*
  •   no
  •   Approved
  •   D 422/19, Ethikkommission der Christian-Albrechts-Universität zu Kiel
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Secondary IDs

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Health Condition or Problem studied

  •   I46.9 -  Cardiac arrest, unspecified
  •   Out-of-hospital cardiopulmonary resuscitation
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Interventions/Observational Groups

  •   Patients are treated as recommended by the guidelines of the European Rescuscitation Council, but chest compressions are exclusively performed manual.
  •   Patients are treated as recommended by the guidelines of the European Rescuscitation Council, chest compressions are performed at some time with the corpuls cpr
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Other
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Treatment
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

24h-survival

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Secondary Outcome

30d-survival or hospital discharge

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
  • other 
  • other 
  • other 
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Recruitment

  •   Actual
  •   2020/01/01
  •   6600
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

out-of-hospital cardiac arrest with resuscitation

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Exclusion Criteria

traumatic cardiac arrest

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Addresses

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    • GS Elektromedizinische Geräte G. Stemple GmbH
    • Hauswiesenstraße 26
    • 86916  Kaufering
    • Germany
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    • Universitätsklinikum Schleswig-Holstein, Institut für Rettungs- und Notfallmedizin
    • Mr.  Prof. Dr. med.  Jan-Thorsten  Gräsner 
    • Arnold-Heller-Str. 3 Haus 808
    • 24105  Kiel
    • Germany
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    • Universitätsklinikum Schleswig-Holstein, Institut für Rettungs- und Notfallmedizin
    • Mr.  Prof. Dr. med.  Jan-Thorsten  Gräsner 
    • Arnold-Heller-Str. 3 Haus 808
    • 24105  Kiel
    • Germany
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Sources of Monetary or Material Support

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    • GS Elektromedizinische Geräte G. Stemple GmbH
    • Hauswiesenstraße 26
    • 86916  Kaufering
    • Germany
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Status

  •   Recruiting ongoing
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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.