Trial document




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  DRKS00004412

Trial Description

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Title

Randomized comparative study for securing the airway during thoracalsurgery with double lumen tube vs endotracheal video tubs + bronchusblocker

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

We will compare to methods for single-lung ventilation: A double-lumen tube and tracheal tube with a integrated video camera combined with a directable bronchial blocker

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Brief Summary in Scientific Language

For airway management during thoracic surgery with the need of single-lung ventilation (SLV) currently two methods are established: the classical double-lumen tube (DLT) as well as the ETView in combination with a directable bronchial blocker. In our hospital we routinely use the DLT size 35F and 37F, both to be inserted into the right or left main bronchus. The ETView is regular tracheal tube equipped with an integrated camera. A bronchus blocker inserted via the ETView can thus be direct towards the intended main bronchus and inflated under visual control. Both products are CE certified and will be used with their intended specification.
Based on our experiences we hypothesize that use of an ETView is associated with the following advantages: faster induction of anesthesia and recovery. Reduced airway morbidity. From the economical point of view we hypothesize that use of the ETView may help to speed up process times as well as to reduce the over all costs. Till now, no randomized studies comparing the DLT and the ETView are available. In order to accept or refute our hypotheses run the the presented study.

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Organizational Data

  •   DRKS00004412
  •   2012/10/08
  •   [---]*
  •   yes
  •   Approved
  •   26/6/12, Ethik-Kommission der Medizinischen Fakultät der Georg-August-Universität Göttingen
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Secondary IDs

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

  •   pleuraempyema
  •   J86 -  Pyothorax
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Interventions/Observational Groups

  •   doublelumen tube RobertShaw for installation of single lung ventilation
  •   endotracheal videotube ETView Viva sight SL plus maneuverable endobronchial blocker for installation of single lung ventilation
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject
  •   Active control
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Airway morbidity 2 and 24 hours postoperatively (assessed by numeric analog scale (1-10)) , time from induction of anesthesia until clearance to start surgery.

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Secondary Outcome

anesthesia cost per intervention, surgical conditions evaluated by the responsible surgeon

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2012/09/13
  •   50
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

all Patients who have to undergo a VATS

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Exclusion Criteria

patients who need a thorakotomy or a VATS plus an secondary procedure

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Addresses

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    • Diakoniekrankenhaus Rotenburg Wümme Institut für Anästhesie und operative Intensivmedizin
    • Mr.  Dr. med.  Gerhard  Lehrbach 
    • Elise Averdieck Str 17
    • 27356  Rotenburg
    • Germany
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    • Universitätsmedizin Göttingen ZARI
    • Mr.  PD Dr. med.  Sebastian  Russo 
    • Robert-Koch-Straße 40
    • 37099  Göttingen
    • Germany
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    • Diakoniekrankenhaus Rotenburg Wümme Institut für Anästhesie und operative Intensivmedizin
    • Mr.  Oliver  Klinger 
    • Elise Averdieck Str 17
    • 27356  Rotenburg
    • Germany
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    • Diakoniekrankenhaus Rotenburg Wümme Institut für Anästhesie und operative Intensivmedizin
    • Mr.  Oliver  Klinger 
    • Elise Averdieck Str 17
    • 27356  Rotenburg
    • Germany
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Sources of Monetary or Material Support

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    • Diakoniekrankenhaus Rotenburg Wümme Institut für Anästhesie und operative Intensivmedizin
    • Mr.  Dr. med.  Gerhard  Lehrbach 
    • Elise Averdieck Str 17
    • 27356  Rotenburg
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2014/02/28
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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.