Trial document




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  DRKS00016627

Trial Description

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Title

Evaluation of the Impact of Prehospital eCPR on Outcome following Out of Hospital Cardiac Arrest

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Out-of-hospital cardiac arrest is the most critical emergency in preclinical emergency medicine. The rescue service in Baden-Wuerttemberg must arrive according to legal regulation within 10-15 minutes at the emergency place. In the case of resuscitation, the onset of cardiopulmonary resuscitation is crucial. Already after 3 minutes irreversible neurological deficits can be recorded. The chance of survival in a cardiovascular arrest per minute drops by about 10 percent. There are currently various approaches to increase this low rate by improving the resuscitation process. This includes the prehospital use of ECLS devices (mobile heart and lung machine, which ensures circulation and oxygen supply). This so-called eCPR is a supplement to the extended resuscitation measures. It is part of the internationally valid resuscitation guidelines and is used in case of failure of conventional measures. In Freiburg, a vehicle has been maintained by the UHZ since September 2018, which brings an ECLS system for the implementation of the eCPR and expert / specialized personnel to the site after alerting.

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Brief Summary in Scientific Language

Out-of-hospital cardiac arrest is the most critical emergency in preclinical emergency medicine. The rescue service in Baden-Wuerttemberg must arrive according to legal regulation within 10-15 minutes at the emergency place. In the case of resuscitation, the onset of cardiopulmonary resuscitation is crucial. Already after 3 minutes irreversible neurological deficits can be recorded. The chance of survival in a cardiovascular arrest per minute drops by about 10 percent. In the state of Baden-Württemberg, 5,054 resuscitation rallies were recorded in 2017 (SQR-BW Annual Report 2017). The incidence for the rescue service area Freiburg is about 150 resuscitations / year. The one-year survival rate of patients with out-of-hospital cardiovascular arrest remains consistently low at around six percent (Hutin, 2018). There are currently various approaches to increase this low rate by improving the resuscitation process. This includes the prehospital use of ECLS devices (mobile heart and lung machine, which ensures circulation and oxygen supply). This so-called eCPR is a supplement to the extended resuscitation measures. It is part of the internationally valid resuscitation guidelines and is used in case of failure of conventional measures. In Freiburg, a vehicle has been maintained by the UHZ since September 2018, which brings an ECLS system for the implementation of the eCPR and expert / specialized personnel to the site after alerting.

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Organizational Data

  •   DRKS00016627
  •   2019/04/04
  •   [---]*
  •   yes
  •   Approved
  •   481/18, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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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

  •   Patient collective, which is supplied as part of a cardiovascular arrest by means of eCPR / was compared to patient collective, which has not received any eCPR measure.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Health care system
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Improvement of survival and neurological recovery after out-of-hospital cardiovascular arrest

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Secondary Outcome

Questions on the quality assurance of the deployment system, process times, feasibility of the non-clinical application, parameters of the clinical course of treatment, interventions, complications

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2019/04/05
  •   150
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   no minimum age
  •   75   Years
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Additional Inclusion Criteria

Patients who need to be resuscitated when the rescue service arrives

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Exclusion Criteria

Patients who are not in need of resuscitation on arrival of the rescue service or patients with trauma as a cause for resuscitation

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Addresses

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    • UHZ Freiburg bad Krozingen
    • Mr.  PD Dr.  Georg  Trummer 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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    • UHZ Freiburg bad Krozingen
    • Mr.  PD Dr.  Georg  Trummer 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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    • UHZ Freiburg bad Krozingen
    • Mr.  PD Dr.  Georg  Trummer 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • UHZ Freiburg bad Krozingen
    • Mr.  PD Dr.  Georg  Trummer 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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