Trial document




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  DRKS00004945

Trial Description

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Title

Prospective validation of an electronic security checklist ("InduCheck") at induction of anesthesia by specialist doctors

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Trial Acronym

Induct-Check II

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URL of the Trial

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Brief Summary in Lay Language

During the induction of general anesthesia, there are many security related steps and activities to be performed. A previous study showed that junior doctors using an electronic checklist performed significantly more security-related steps and activities than without. We want to validate these positive results in another collective (specialists of Anaesthesia in a general hospital) and we want to objectify the team behavior of specialists in this situation using a validated team performance score (ANTS: Anaesthetists Non-Technical Skills). Therefore, the induction of anesthesia will be documented by video. Moreover, this is followed by a structured survey of anesthetists and patient acceptance of this benefit and acceptance of this security tool.
In the preliminary study, more adverse hypotensive phases were detected in the checklist group, probably due to significantly more frequent blood pressure measurements at smaller measurement interval in the checklist group. To prospectively confirm this plausible explanation we will measure continuously non-invasively the blood pressure during induction of anesthesia, this measurement will be blinded during the induction and evaluated afterwards.

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Brief Summary in Scientific Language

During the induction of general anesthesia, there are many security related steps and activities to be performed. A previous study showed that junior doctors using an electronic checklist performed significantly more security-related steps and activities than without. We want to validate these positive results in another collective (specialists of Anaesthesia in a general hospital) and we want to objectify the team behavior of specialists in this situation using a validated team performance score (ANTS: Anaesthetists Non-Technical Skills). Therefore, the induction of anesthesia will be documented by video. Moreover, this is followed by a structured survey of anesthetists and patient acceptance of this benefit and acceptance of this security tool.
In the preliminary study, more adverse hypotensive phases were detected in the checklist group, probably due to significantly more frequent blood pressure measurements at smaller measurement interval in the checklist group. To prospectively confirm this plausible explanation we will measure continuously non-invasively the blood pressure during induction of anesthesia, this measurement will be blinded during the induction and evaluated afterwards.

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Organizational Data

  •   DRKS00004945
  •   2014/07/07
  •   [---]*
  •   yes
  •   Approved
  •   EA4/044/13, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

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Health Condition or Problem studied

  •   secure process of anaesthesia induction
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Interventions/Observational Groups

  •   We will observe several times the routine procedure of induction of general anesthesia as performed by a doctor specialized in the field of anaesthesia.
  •   After presenting and explaining the use of the checklist, we will observe the induction process performed by the same doctors specialized in Anaesthesia while they make use of the checklist.
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Characteristics

  •   Interventional
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  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Other
  •   Prevention
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

1 Number of performed safety-related items (with vs. Checklist no)
2 Hypotension: count per induction, defined as systolic blood pressure> -20% (from baseline blood pressure in pre-medication) or MAD <55 mmHg (conventional measurement vs. continuous measurement

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Secondary Outcome

• Number of blood pressure measurements; selected measurement interval
• Duration of induction
• Cumulative norepinephrine dose per Induction
• FE02 (expiratory oxygen fraction)> 0.7 is reached (as a sign of adequate pre-oxygenation s)?
• Duration of pre-oxygenation (defined as the time between positioning of the mask and injection of hypnotic)
• Capnography visible as a curve with pre-oxygenation as a sign of a tight-fitting mask ?
• Team performance using ANTS (anesthetists non-technical skills) score

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Planned
  •   2014/07/09
  •   75
  •   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

ASA risk classification I-III, age> 18 years old, written consent of the patient, consent of anesthesiologist and nursing staff

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Exclusion Criteria

Age <18 years, ASA risk classification IV and V, contraindication to induction of anesthesia with propofol, Expected difficult airway, lack of consent of the patient or anesthesiologist or nurse staff

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Addresses

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    • Klinik für Anästhesiologie mit Schwerpunkt operative IntensivmedizinCharité – Campus Benjamin Franklin
    • Mr.  Dr  Christian  Reich 
    • Hindenburgdamm 30
    • 12200  Berlin
    • Germany
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    • Charité Universitätsmedizin BerlinCBFKlinik für Anästhesiologie mit Schwerpunkt operative Intensivmedizin
    • Mr.  Dr.  Christian  Reich 
    • Hindenburgdamm 30
    • 12200  Berlin
    • Germany
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    • Sankt Gertrauden Krankenhaus
    • Ms.  Annette  Brückner 
    • Paretzer Str 12
    • 10713  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Charité Universitätsmedizin BerlinCBFKlinik für Anästhesiologie mit Schwerpunkt operative Intensivmedizin
    • Mr.  Dr.  Christian  Reich 
    • Hindenburgdamm 30
    • 12200  Berlin
    • Germany
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Status

  •   Recruiting planned
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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.