Trial document




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  DRKS00005782

Trial Description

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Title

Comparison of safety systems for blood collection systems and safety systems for port needles - a simulation manikin stuy.

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

With this comparative simulation study should be examined by inexperienced users (medical students) for the first time, the handling and ease of use of different safety mechanisms of safety blood collection systems, as well as safety port needles. In particular, the question of which safety mechanism can be activated easiest and most reliable, will be answered by this study. The findings and the discoveries will directly improve health and safety for the healthcare personnel and provide the basis for the derivation of future preventive measures. At the same time a system based on a video analysis simulation model for the evaluation of security mechanisms should be established within the framework of this research project.

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Brief Summary in Scientific Language

Needlestick injuries among health care personnel are a particular challenge for occupational safety and occupational medicine (Himmelreich et al. 2013). In order to protect personnel from injuries in activities with a sharp medical instruments, there are mandatory requirements for occupational safety and use of a so-called safety mechanism for preventing sharps injuries (TRBA 250). However, this must be triggered usually active by the employees (Haamann 2012). Through the use of security mechanisms, the incidence of needlestick injuries can be effectively reduced (Lamontagne et al. 2007 Laramie et al. 2011). But despite these safeguards, needlestick injuries are still occuring, for example, during activation of the safety mechanism, or by a lack of activation of the safety mechanism by the employees (Black et al. 2012). So far, it remains unclear whether the reasons for this are the design of the safety mechanism or inadequate training and lack of experience are justified by the safety mechanism (Laramie et al. 2011). Only passive safety mechanisms seem to be superior to active, ie be triggered manually by the user, safety mechanisms (Tosini et al. 2010). However, these are e.g. not available in the field of safety blood collection systems (Tosini et al. 2010). Previous studies are limited so far to the comparison of two identical safety mechanisms of catheter needles from different manufacturers with conventional catheter needles in clinical practice (Asai et al. 2002), the evaluation of a single new safety mechanism by questionnaire in clinical practice (Feng et al. 2009) or the investigation two safety mechanisms of needles on the simulation model (Adams et al. 2003). Corresponding studies in safety blood collection systems and safety port needles have not been carried out and also the variety of safety mechanisms available on the market was not considered (Haamann 2012). In a recent study, the following of safety measures was measured for the first time using video analysis when dealing with a sharp medical instruments (Iso et al. 2012). This type of analysis offers a number of advantages over conventional observations and surveys by questionnaire (eg retrospective analysis by several observers, assessing individual subtasks, exact timing provisions, etc.). In addition, we were able to show in a separate preliminary work that the simulation model-specific differences of comparable medical devices, such as handling of video laryngoscopes, can be examined independent from the application on the patient (Kalbhenn et al. 2012). In the procurement of safety blood collection systems or safety port needles a recent American statement expressly pointed out the critical role of direct users and the integration of employees in the procurement process (Jagger et al. 2013) . At the University Hospital the above safety blood collection systems and safety port needle are usually used by medical students. Therefor, based on the studies published to date (Asai et al. 2002, Adams et al. 2003), a total of 30 third year medical students are included in the study.

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Organizational Data

  •   DRKS00005782
  •   2014/03/03
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  •   yes
  •   Approved
  •   44/14, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

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Health Condition or Problem studied

  •   Evaluation of safety systems for blood collection systems and port needles with safety systems
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Interventions/Observational Groups

  •   Puncture on the iv manikin arm (Laerdal Medical GmbH) with the Venofix® Safety blood collection system (Braun Melsungen AG)
  •   Puncture on the iv manikin arm (Laerdal Medical GmbH) with the Safety-Multifly® safety blood collection system (SARSTEDT)
  •   Puncture on the iv manikin arm (Laerdal Medical GmbH) with the BD Push Button (BD) safety blood collection system
  •   Puncture on the iv manikin arm (Laerdal Medical GmbH) with the Surflo® safety blood collection system (TERUMO)
  •   Puncture on the port needle simulation model (B. Braun Melsungen AG) with the Surecan® SafeStep® (B. Braun Melsungen AG) safety port needle
  •   Puncture on the port needle simulation model (B. Braun Melsungen AG) with the Perfusafe2 (VYGON) safety port needle
  •   Puncture on the port needle simulation model (B. Braun Melsungen AG) Ambix Intrastick® Safe (Fresenius Kabi) safety port needle
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control
  •   Other
  •   Crossover
  •   N/A
  •   N/A
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Primary Outcome

- Activation of safety-mechanism yse/no ja/nein
- Timepoint of activation of safety-mechanism
- One-hand activation of safety-mechanism
- Questionnaire for each safety-mechanism
- Preferred safety-mechanism
- Reason for preference of a safety-mechanism

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Secondary Outcome

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2014/02/17
  •   30
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

5th semester medical students

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Exclusion Criteria

Prior health care education (nurse, emergency paramedic, midwife, doctor's assistant, surgical assistant)

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Addresses

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    • Universitätsklinikum Freiburg Stabsstelle Klinikumsvorstand Betriebsärztlicher Dienst
    • Mr.  Dr. med.  Daniel  Steinmann 
    • Berliner Allee 6
    • 79110  Freiburg
    • Germany
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    • Universitätsklinikum Freiburg Stabsstelle Klinikumsvorstand Betriebsärztlicher Dienst
    • Mr.  Dr. med.  Daniel  Steinmann 
    • Berliner Allee 6
    • 79110  Freiburg
    • Germany
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    • Universitätsklinikum FreiburgStabsstelle KlinikumsvorstandBetriebsärztlicher Dienst
    • Mr.  Dr. med.  Daniel  Steinmann 
    • Berliner Allee 6
    • 79110  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Freiburg Stabsstelle Klinikumsvorstand Betriebsärztlicher Dienst
    • Mr.  Dr. med.  Daniel  Steinmann 
    • Berliner Allee 6
    • 79110  Freiburg
    • 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.