Trial document




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  DRKS00024968

Trial Description

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Title

Intubation using VieScope, video laryngoscopy and conventional laryngoscopy in simulated difficult airway - a randomized, controlled model study

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Trial Acronym

[---]*

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Endotracheal intubation continues to be the gold standard of airway management in emergency situations. This is primarily done using direct laryngoscopy, but is increasingly being supplemented by video laryngoscopy and in some cases even replaced. A dreaded situation in airway management is the difficult intubation due to anatomical conditions.
A unknown difficult airways can thus be a great challenge for the treating staff and a rapidly life-threatening situation for the patient.

The VieScope® (Androit Surgical LCCC, Oklahoma City, USA) represents a new type of laryngoscopy, which, according to the manufacturer, leads to optimal illumination of the airways.
The VieScope has not yet been examined in any clinical study. There are therefore no published data on the safety of use and no comparison with established methods of airway management such as video laryngoscopy or direct laryngoscopy.

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Brief Summary in Scientific Language

Is the intubation and thus airway securing with VieScope safe (success rate) and efficient (time duration) compared to conventional video laryngoscopy (GlideScope) and direct laryngoscopy in simulated difficult airway?

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

No

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Description IPD sharing plan:

all data will be published

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Organizational Data

  •   DRKS00024968
  •   2021/03/31
  •   [---]*
  •   yes
  •   Approved
  •   20-1475_2, Ethik-Kommission der Medizinischen Fakultät der Universität zu Köln
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Secondary IDs

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

  •   DIFFICULTAIRWAY
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Interventions/Observational Groups

  •   endotracheal intubation with VieScope
  •   endotracheal intubation with Videolaryngoscopy (Glidescope)
  •   endotracheal intubation with conventional endotracheal Intubation (Macintosh)
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control (effective treament of control group)
  •   Treatment
  •   Other
  •   N/A
  •   [---]*
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Primary Outcome

1. Tube position: tracheal, bronchial, oesophageal (primary endpoint), immediately after Intubation, validated by insufflation of the test lung

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Secondary Outcome

2. Correct tube position for the first intubation - "first pass" (secondary endpoint)
3. Time to Intubation (Secondary Endpoint)
4. Time to first ventilation (secondary endpoint)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2021/04/01
  •   35
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

• male or female volunteers
• medical healthcare professionals
• Age between 18 and 65 years
• Prior written consent following written and verbal information from an investigator

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Exclusion Criteria

• male or female volunteers
• medical healthcare professionals
• Age between 18 and 65 years
• Prior written consent following written and verbal information from an investigator

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Uniklinik Köln - Anästhesie und operative Intensivmedizin
    • Mr.  Dr.med.  Hannes  Ecker 
    • Kerpenerstraße 62
    • 50937  Köln
    • Germany
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    • Uniklinik Köln - Klinik für Anästhesiologie und Operative Intensivmedizin
    • Mr.  Dr.med.  Hannes  Ecker 
    • Kerpenerstraße 62
    • 50935  Köln
    • Germany
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    • Uniklinik Köln - Klinik für Anästhesiologie und Operative Intensivmedizin
    • Mr.  Dr.med.  Hannes  Ecker 
    • Kerpenerstraße 62
    • 50935  Köln
    • Germany
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Sources of Monetary or Material Support

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    • Uniklinik Köln - Klinik für Anästhesiologie und Operative Intensivmedizin
    • Mr.  Dr.med.  Hannes  Ecker 
    • Kerpenerstraße 62
    • 50935  Köln
    • Germany
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Status

  •   Recruiting planned
  •   [---]*
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Trial Publications, Results and other Documents

  •   Ethikvotum
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* This entry means the parameter is not applicable or has not been set.