Trial document





This trial has been registered retrospectively.
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  DRKS00010090

Trial Description

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Title

Randomized multi-centric trial comparing the classical double lumen endobronchial tube and the ViviSight double lumen endobronchial tube for airway management during thoracic surgery

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Comparison of two different models of ventilation tubes for airway management and single-lung ventilation in the context of thoracic surgical operations.
The comparison takes place on thoracic surgical patients with different diseases, among others Lung cancer, pneumothorax, pulmonary nodules of unknown cause

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Brief Summary in Scientific Language

Study to compare a classical double-lumen tube to a double-lume tube with an incorporated optical system (VivaSight) for airway management during thoracic surgery in regard to airway morbidity, intraoperative setting, cost / time savings, operating conditions of Anesthesiology and Surgery

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Organizational Data

  •   DRKS00010090
  •   2016/04/05
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  •   no
  •   Approved
  •   13/12/14, 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

  •   C34.9 -  Malignant neoplasm: Bronchus or lung, unspecified
  •   J93.9 -  Pneumothorax, unspecified
  •   Lung cancer, pneumothorax
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Interventions/Observational Groups

  •   Standard double lumen endobronchial tube, 37-39Ch with use of bronchoscopy
  •   visualized double lumen endobronchial tube Vivasight, 37-39Ch, controlled by integrated camera
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Other
  •   Basic research/physiological study
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Time from start to finish of anesthesia induction, need for intraoperative control tube position
Feedback directly from surgeon/anesthesist with questionnaire
Feedback from Patient until 90minutes after surgery as well as first day following surgery regarding airway morbidity and wound pain.

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Secondary Outcome

costs per anesthesia,
Evaluation of intraoperative conditions by surgeon,
Evaluation of conditions by anesthesist

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2015/12/17
  •   75
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

female with body hight of 150-175cm, male with body hight of 165-185cm

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Exclusion Criteria

Body size others than mentioned
Expected difficult airway
Refusal of written informed consent

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Addresses

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    • Klinik für AnästhesiologieUniversitätsmedizin Göttingen
    • Mr.  Prof.  Sebastian   Russp 
    • Robert-Koch-Strasse 40
    • 37075  Göttingen
    • Germany
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    • Universitätsklinikum Göttingen
    • Mr.  Professor  Sebastian  Russo 
    • Robert-Koch-Strasse 40
    • 37075  Göttingen
    • Germany
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    • Klinik für AnästhesiologieUniversitätsmedizin Göttingen
    • Mr.  Professor  Sebastian  Russo 
    • Robert-Koch-Strasse 40
    • 37075  Göttingen
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsmedizin GöttingenKlinik für Anästhesiologie
    • Mr.  Professor  Sebastian  Russo 
    • Robert-Koch-Strasse 40
    • 37075  Göttingen
    • 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.