Trial document





This trial has been registered retrospectively.
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  DRKS00020978

Trial Description

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Title

Prospective, randomised, controlled study comparing Videolaryngoscopy versus Direct Laryngoscopy for Double-Lumen Endotracheal Tube Intubation

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Trial Acronym

Videolaryngoscopy versus Direct Laryngoscopy for DLT Intubation

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URL of the Trial

[---]*

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Brief Summary in Lay Language

We investigated the impact of videolaryngoscopy for double-lumen tube (DLT) intubation in thoracic anaesthesia with videolaryngoscopy (GVL) using a thin GlideScope®-Titanium single use blade.
Methods:
A clinical, prospective, randomised, controlled trial was conducted with a total of 70 patients undergoing elective thoracic surgery and need for a DLT intubation. Finally, 65 patients were analysed (DL group [nā€Š=ā€Š31] vs. GVL group [nā€Š=ā€Š34]). Endpoints were time to intubate, subjective symptoms and objective trauma of the oropharynx and supraglottic space.

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Brief Summary in Scientific Language

Prospective, randomised, controlled study comparing Videolaryngoscopy versus Direct Laryngoscopy for Double-Lumen Endotracheal Tube Intubation

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Do you plan to share individual participant data with other researchers?

No

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Description IPD sharing plan:


on request yes

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Organizational Data

  •   DRKS00020978
  •   2020/03/09
  •   [---]*
  •   yes
  •   Approved
  •   115/16, Ethik-Kommission des Fachbereichs Medizin der Philipps-Universität Marburg
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Secondary IDs

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

  •   T88.4 -  Failed or difficult intubation
  •  
    Intubation traumata
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Interventions/Observational Groups

  •   DLT Intubation with Videolaryngoscopy Glidescope Titanium Blade
  •   DLT Intubation with dirt Laryngoscopy
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, assessor, data analyst
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   IV
  •   N/A
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Primary Outcome

Endpoints were time to intubate, Measurement time in seconds during procedure

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Secondary Outcome

Subjective symptoms and objective trauma of the oropharynx and supraglottic space. Measurement after surgery and 24 h after surgery with a patients questionnaire and nasal endoscopic follow up.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2017/02/27
  •   70
  •   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

Adult patients scheduled for elective thoracic surgery requiring general anaesthesia with the need of a double-lumen tube (DLT)

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Exclusion Criteria

The main exclusion criterion was patients aged less than 18 years. In addition, non-fasting patients, pregnant women and patients with gastro-oesophageal reflux disease, which were indicated for rapid-sequence induction, were excluded from the study. Other exclusion criteria were the following: contraindication to a left or right DLT; contraindication to one-lung ventilation; and an abnormal physical status of the Cervical spine (e.g., after C-spine trauma, Bechterew's disease).

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Addresses

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    • Klinik für Anästhesie und Intensivmedizin, Universitätsklinikum Marburg
    • Mr.  Dr. med.  Carsten  Feldmann 
    • Baldingerstraße
    • 35043  Marburg
    • Germany
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    • Universitätsklinikum Essen
    • Hufelandstraße 55
    • 45147  Essen
    • Germany
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    • Universitätsklinikum Gießen und Marburg, Standort Marburg
    • Mr.  Dr. med.  Joachim  Riße 
    • Baldingerstraße
    • 35033  Marburg
    • Germany
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    • Universitätsklinikum Gießen und Marburg, Standort Marburg
    • Mr.  Dr. med.  Joachim  Risse 
    • Baldingerstraße
    • 35033  Marburg
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Gießen und Marburg, Standort Marburg
    • Baldingerstraße
    • 35033  Marburg
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2017/09/18
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Trial Publications, Results and other Documents

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