Trial document




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  DRKS00005581

Trial Description

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Title

Application study of ultrasound-guided regional anesthesia and puncture procedures on a phantom gel model

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The use of ultrasound-guided procedures for regional anesthesia and endovascular punctures has increased during the recent years. We evaluate the influence of a new needle-tracking technique in real-time ultrasonography imaging on the duration of puncture procedures. Anesthesiologists with different levels of education place needles for regional anesthesia and vascular acess in a ultrasound-phantom. Candidates are recruited from the medical staff of the Clinic of Anesthesiology and Intensive Care.

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Brief Summary in Scientific Language

The use of ultrasound-guided procedures for regional anesthesia and vascular acess has increased during the recent years. A new navigation needle-tracking technique is able to visualize the needle in real-time ultrasonography imaging. In contrast to the standard ultrasound-technique, the exact position and movements of the needle can always be displayed. We test the hypothesis that using a new ultrasound technique reduces the duration for vascular acess and regional anesthesia. Primary endpoint is the time required for correct needle positioning conducted on a training phantom. Candidates are recruited from the medical staff of the Clinic of Anesthesiology and Intensive Care of the University Hospital of Cologne having different experience in ultrasound-guided regional anesthesia procedures.

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Organizational Data

  •   DRKS00005581
  •   2013/12/10
  •   [---]*
  •   yes
  •   Approved
  •   13-303, Ethik-Kommission der Medizinischen Fakultät der Universität zu Köln
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Secondary IDs

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Health Condition or Problem studied

  •   ultrasound-guided anesthesia and vascular acess
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Interventions/Observational Groups

  •   Candicates will perfoma ultrasound-guided punctures for regional anesthesia and vascular acess.
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Time required for correct needle positioning

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Secondary Outcome

satisfaction with the technique, questionnaire validation

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

  •   Actual
  •   2013/12/20
  •   30
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

medical staff of the Clinic of Anesthesiology and Intensive Care

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Exclusion Criteria

see inclusion criteria

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Addresses

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    • Klinik für Anästhesiologie und Operative Intensivmedizin, Uniklinik Köln
    • 50937  Köln
    • Germany
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    • Klinik für Anästhesiologie und Operative Intensivmedizin
    • Mr.  Dr. med.  Robert  Schier 
    • Kerpener Straße 62
    • 50937  Köln
    • Germany
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    • Klinik für Anästhesiologie und Operative Intensivmedizin
    • Mr.  Dr. med.  Robert  Schier 
    • Kerpener Straße 62
    • 50937  Köln
    • Germany
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Sources of Monetary or Material Support

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    • Klinik für Anästhesiologie und Operative Intensivmedizin, Uniklinik Köln
    • Kerpener Straße 62
    • 50937  Köln
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2014/01/31
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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.