C-Spine Movement - Shikani Optical Scope vs Macintosh Laryngoscope for Patients With Cervical Spine Injury
Condition: Wounds and Injuries
MeSH terms: Wounds and Injuries
Study type: Interventional

Summary: 
      Patients undergoing surgery will have laryngoscopy performed using two widely accepted
      techniques - Macintosh Laryngoscope and Shikani Optical Scope. The techniques will be timed
      and compared for cervical spine movement using fluoroscopy.
    

Detailed description: 
      Approval for the study has been obtained from the Review Board for Health and Sciences
      Research Involving Human Subjects of the University of Western Ontario. Informed and written
      consent will be obtained from patients who are undergoing elective surgery requiring general
      anesthesia with endotracheal intubation. Preoperative clinical assessment of the patients
      will include routine airway evaluation of dentition, mouth opening, tongue size, Mallampati
      score, and neck mobility.

      While awake, the patients will be placed on the operating room table with a rigid board under
      their head, neck, and torso in order to simulate the table on which patients involved in
      trauma are placed in the emergency room. In-line stabilization (ILS), as recommended by the
      ATLS guidelines, will be applied to maintain the patient's head in the neutral position and
      reduce neck movement during laryngoscopy.

      After standard pre-oxygenation, anesthesia will be induced in routine fashion with 2-3 mg/kg
      propofol and 2-5 mcg/kg fentanyl; rocuronium 0.8 mg/kg will be administered to effect muscle
      paralysis. The patient will be then be ventilated with sevoflurane in 100% Oxygen via bag and
      mask for 3 minutes.

      After the patient is anesthetized, a sealed envelope containing computer a generated random
      assignment will be opened. Laryngoscopy will then be performed two times, with the Macintosh
      laryngoscope and with the Shikani Optical Scope, in random order as determined by the
      envelope. Between laryngoscopies, the patient will be ventilated with sevoflurane in 100%
      Oxygen.

      For direct Macintosh laryngoscopy, a size 3 laryngoscope blade will be recommended in all
      patients. With laryngoscopy, the glottis will be exposed to enable positioning of the
      endotracheal tube at the vocal cords. During the second laryngoscopy in the above sequence,
      the trachea will be intubated.

      The study is then complete. The hard board will be removed and the surgery will proceed in
      the usual fashion.

      The laryngoscopy and intubation will be recorded by a portable fluoroscopy unit for
      subsequent review by the radiologist to assess relative neck movement.

      Laryngoscopy time will be defined as the time from when the laryngoscope blade or Shikani
      stylet passes the teeth of the patient until the time the endotracheal tube is positioned at
      the opening of the larynx. If the intubation sequence is longer than 120 seconds, it will be
      deemed a failure and recorded as such.

      The Cormack (11) of the larynx will be recorded for all patients.
    

Intervention name(s): Shikani Optical Stylet
Intervention type(s): Device
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single
Primary purpose: Treatment
Keywords: Cervical Vertebrae; Intubation, Intratracheal; Laryngoscopes; Fluoroscopy