Awake Intubation V-MAC VS
Condition: Intubation;Difficult
Study type: Observational

Summary: 
      Nowadays, the gold standard for difficult airway management is awake intubation with a
      flexible fiberscope. Alternatively, when the flexible fiberscope is unable to facilitate
      tracheal intubation, rigid stylets may be used. One newly developed rigid video stylet also
      features a flexible tip (C-MAC VS, Karl Storz AG, 78532 Tuttlingen, Germany). The distal
      angular offset of the C-MAC VS, in which the camera and light sources are integrated, can be
      aligned (up to 60°) to the patient's anatomical structures to facilitate intubation.

      Although awake intubation is less comfortable for the patient and more time consuming, there
      are several reasons why this is often performed. The investigators plan a prospective
      observational with 36 participants using the C-MAC VS on adult patients with indication for
      awake oral intubation.

      To ease the placement of the tube (intubation), the investigators will use local anesthesia
      of the mucosa in the mouth, pharynx and larynx.

      The main purpose of the study is to prove the feasibility of successful awake intubation with
      the C-MAC VS in adult patients. If the new device proves reliable in facilitating awake oral,
      future patients benefit from an additional tool that allows fast and safe intubation in
      difficult airway situations.
    

Detailed description: 
      In the majority of cases, airway management is uncomplicated and a straightforward procedure.
      Nevertheless, in rare cases complications are associated with notably high rates of serious
      consequences.

      Therefore, assured and reliable intubation is fundamental to safe anesthetic practice.

      Various approaches were introduced by the medical device industry to optimize intubation
      procedure. Nowadays, the gold standard for difficult airway management is awake intubation
      with a flexible fiberscope. Alternatively, when the flexible fiberscope is unable to
      facilitate tracheal intubation, rigid stylets may be used. One newly developed rigid video
      stylet also features a flexible tip (C-MAC VS, Karl Storz AG, 78532 Tuttlingen, Germany). The
      C-MAC VS is an advancement of the rigid "Bonfils" stylet (Karl Storz, Karl Storz AG, 78532
      Tuttlingen, Germany). The distal angular offset of the C-MAC VS, in which the camera and
      light source are integrated, can be aligned (up to 60°) to the patient's anatomical
      structures to facilitate intubation.

      Although awake intubation is less comfortable for the patient and more time consuming, there
      are several reasons why this is often performed.

      In this research project, the investigators plan a prospective observational study using the
      C-MAC VS on adult patients with indication for awake oral intubation. Spontaneous ventilation
      will be maintained until confirmation of tracheal intubation.To ease the placement of the
      tube (intubation), the investigators will use local anesthesia of the mucosa in the mouth,
      pharynx and larynx.

      The study physician will intubate the trachea of the patient using the C-MAC VS. Another
      person of the study team will record the primary and secondary outcomes on the Case Report
      Form.

      After intubation, the anesthetist evaluates the intubation. Participants will be followed up
      for procedure related complications after the intubation and on the 1st post-anesthesia day
      to evaluate patient intubation comfort (VAS 1: very easy to 10: very hard).

      The main purpose of the study is to prove the feasibility of successful awake intubation with
      the C-MAC VS in adult patients. If the new device proves reliable in facilitating awake oral,
      future patients benefit from an additional tool that allows fast and safe intubation in
      difficult airway situations.
    

Intervention name(s): C-MAC VS
Intervention type(s): Device
Intervention description(s): C-MAC VS, Karl Storz AG, 78532 Tuttlingen, Germany It has a flexible tip and a distal angular offset, in which the camera and light sources are integrated. It can be aligned (up to 60°) to the patient's anatomical structures to facilitate intubation.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All adult patients undergoing general anaesthesia for an elective prodcedure at the
        University Hospital of Bern will be screened using the Anästhesie Informations System
        (AIS). If a patient meets our inclusion/exclusion criteria, the investigators will visit
        him personally and confirm, that all criteria are met. Then, written informed consent will
        be obtained and the study can begin.