Trial document




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  DRKS00009535

Trial Description

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Title

Analysis of triage and initial treatment of maritime salvaged refugees during the EU Mission EUNAVOR MED - a secondary data analysis

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Trial Acronym

maritime salvaged refugees

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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

Since mid 2015 the German media report nearly every day about refugees from Syria and Africa.

Beside several non governmental organizations like „Ärzte ohne Grenzen“ some nations like Italy try to improve the chance to survive with maritime salvage missions.
In this situation the European Union initiated the EUNAVOR MED mission. The German Armed Forces are part of this mission. They participate with two frigates.

The main medical problem ist to identify all ill / injured refugees in a very short period of time.


Questions:
• Wich medical problems has the medical team of the frigate to solve? What preparations have to be done?
• Can the triage (which is done by a physician) be improved by measuring puls rate, peripheral oxygenation and body temperature?

Material and method:
- A secondary data analysis is performed. The primary data was gathered during triage and medical treatment on board of the frigate.
- The recommendations of the STROBE working group (Strengthening the Reporting of Observational Studies in Epidemiology) as well as national recommendations were followed
- The study has been appoved by the ethic committee of the Universität of Ulm, Germany (ID 284/15).
- All datasets are included into the secondary data analysis.
- Several subgoups are analyzed (sex, boat of the refugee, ill/injured vs. healthy refugee, age, pregnancy, ambulant vs. treatment in a sick bay, etc.)

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Organizational Data

  •   DRKS00009535
  •   2015/10/16
  •   [---]*
  •   yes
  •   Approved
  •   284/15, Ethik-Kommission der Universität Ulm
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   maritime salvaged refugees
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Interventions/Observational Groups

  •   Secondary data analysis of all maritim salvaged person who where rescued by one of the frigates of the German Armed Forces during May 2015 and September 2015.
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Characteristics

  •   Non-interventional
  •   Epidemiological study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Diagnostic
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Identifikation of ill / injured patients. All maritime salvaged refugees were briefly examined by a physician. In addition pulsate, peripheral oxygenation and body temperature were measured

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Secondary Outcome

Type of illness / injury and type of initial treatment on board of the frigate.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2015/10/01
  •   1500
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

all maritime salvaged refugees who were salvage by the frigate of the German Armed Forces

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Exclusion Criteria

none

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Bundeswehrkrankenhaus UlmKlinik für Anästhesie und IntensivmedizinSektion Notfallmedizin
    • Mr.  Prof. Dr.  Matthias  Helm 
    • Oberer Eselsberg 40
    • 89081  Ulm
    • Germany
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    • Bundeswehrkrankenhaus UlmKlinik für Anästhesiologie und Intensivmedizin
    • Mr.  Dr.  Martin  Kulla 
    • Oberer Eselsberg 40
    • 89081  Ulm
    • Germany
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    end of 1:1-Block address contact scientific-contact
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Sources of Monetary or Material Support

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    • Bundeswehrkrankenhaus UlmKlinik für Anästhesie und IntensivmedizinSektion Notfallmedizin
    • Mr.  Prof. Dr.  Matthias  Helm 
    • Oberer Eselsberg 40
    • 89081  Ulm
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2016/05/15
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Trial Publications, Results and other Documents

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