Trial document




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  DRKS00003230

Trial Description

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Title

The use of the Airtraq® optical laryngoscope for routine tracheal intubation in patients at a high cardiac risk – a feasibility trial

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Securing the airway and ventilating the lungs during operations and resuscitation is generally conducted by tracheal intubation. Therefor a plastic tube is directed into the trachea with special device the so called "laryngoscope". In some cases tracheal intubation appears difficult or even fails with the standard laryngoscope. The novel Airtraq facilities tracheal intubation. Rare data is available about routine tracheal intubation in patients with cardiac disease. In this trial we want to demonstrate that heart rate and blood pressure are not altered in cardiac patients during tracheal intubation with the Airtraq and that oral bleeding complications (many of these patients are on medication inhibiting blood coagulation) rarely occur.

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Brief Summary in Scientific Language

The Airtraq® optical laryngoscope (Prodol Ltd., Vizcaya, Spain) is a novel disposable device facilitating tracheal intubation in routine and difficult airway patients. No data investigating routine tracheal intubation using the Airtaq® in patients at a high cardiac risk are available at present. Purpose of this study was to investigate the feasibility, hemodynamic implications and side effects of tracheal intubation with the Aitraq® optical laryngoscope, in routine cardiac surgical patients.

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Organizational Data

  •   DRKS00003230
  •   2011/08/15
  •   [---]*
  •   yes
  •   Approved
  •   177/11, Ethik-Kommission an der Medizinischen Fakultät der RWTH Aachen
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Secondary IDs

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

  •   OPS 870-1: Easy endotracheal intubation
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Interventions/Observational Groups

  •   routine Airtraq tracheal intubation in patients scheduled for coronary artery bypass grafting
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Characteristics

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

Duration of intubation (sec)

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Secondary Outcome

Heartrate (bpm), arterial blood pressure (mmHg) and SpO2 before and 1,3, 5 min after tracheal intubation
descriptive: mucosal lesions, bleeding complications and handling

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

  •   Planned
  •   2011/08/16
  •   100
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Coronary artery bypass grafting

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Exclusion Criteria

Emergency surgery, history of difficult intubation, Mallampati IV, reduced neck mobility

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Addresses

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    • Universitätsklinikum Aachen Klinik für Anästhesiologie
    • Mr.  Dr. med.  Gereon  Schälte 
    • Pauwelsstr. 30
    • 52074  Aachen
    • Germany
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    • Universitätsklinikum Aachen Klinik für Anästhesiologie
    • Mr.  Dr. med.  Gereon  Schälte 
    • Pauwelsstr. 30
    • 52074  Aachen
    • Germany
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    • Universitätsklinikum Aachen Klinik für Anästhesiologie
    • Mr.  Dr. med.  Gereon  Schälte 
    • Pauwelsstr. 30
    • 52074  Aachen
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Aachen Klinik für Anästhesiologie
    • Mr.  Dr. med.  Gereon  Schälte, MA 
    • Pauwelsstr. 30
    • 52074  Aachen
    • Germany
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    •   02418088177
    •   [---]*
    •   [---]*
    •   [---]*
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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.