Glottic View in Infants With a Shoulder Roll
Condition: Intubation;Difficult
Study type: Interventional

Summary: 
      This study compares the distance from the operating table to the eye of the laryngoscopist
      while intubating the trachea with or without a shoulder roll. A photo of the glottic opening
      will compare the glottic views in both positions.
    

Detailed description: 
      On the day of the surgery, healthy infants will be evaluated by an anesthesiologist for a
      preoperative clearance and suitability for inclusion in the study. If the infants are
      eligible, the parents will receive a detailed explanation of the study that is written into
      the consent form. Written consent will be obtained from those parents who are willing to
      enroll their children in the study. After consent, the concealed randomization code for the
      next subject in the study will be opened to determine the sequence of the positioning as
      described below.

      The infants will be unpremedicated. In the operating room, anesthesia will be induced using a
      standard inhalational induction (that includes, 70 % nitrous oxide and 30 % oxygen followed
      by 8% sevoflurane). Upon the loss of eyelash reflex, ventilation will be assisted and
      intravascular (IV) access will be secured. Once IV access is established, Propofol, 3 mg/kg
      will be administered and the lungs ventilated with 8% sevoflurane in 100% oxygen for 1
      minute. The randomization code will then determine the order of the laryngoscopy: either no
      shoulder roll or a 2 inch shoulder roll first, then the alternative position. For both
      positions, direct laryngoscopy using a #1 size straight Miller blade will expose the larynx
      to obtain the optimal glottic view. At this point, the distance from the lateral canthus of
      the eye of the anesthesiologist to the level of the table will be recorded (distance A) using
      a standard measure anchored on the operating room table top and a photo of the glottic
      opening will be taken using a high-quality digital hand-held camera. This photo will be
      referred to as photo 1. The shoulder roll will either be removed or inserted under the
      shoulders (based on the randomization) while the anesthesiologist holds the laryngoscopic
      view of the larynx. The anesthesiologist's head will then move (if necessary) up or down to
      establish the optimal view of the larynx again and the distance from the lateral canthus of
      the eye of the anesthesiologist to the table top will again be measured (distance B). A photo
      of the laryngoscopy view (photo 2) will be taken. The entire laryngoscopy will take less than
      30 seconds. If the child desaturates to less than 93%, the study will be aborted and the
      lungs ventilated. An anesthesiologist, who is blind to the study hypothesis, will evaluate
      the photos of the glottis view the Percent of Glottic Opening scale (POGO) in 10% increments.
      The primary outcome will be the distance from the lateral canthus of the anesthesiologist's
      eye to the level of the table with and without a shoulder roll (distance A and distance B)
      will be compared using paired t-test. (P<0.05 will be accepted). The secondary outcome will
      be the glottic views (photos 1 and picture 2) compared using the Kruskall Wallis test.
    

Intervention name(s): Shoulder Roll; No shoulder roll (placebo)
Intervention type(s): Other; Other
Intervention description(s): The POGO score assesses the percent of the glottic opening that can be seen with and without the shoulder roll.; Placebo
Other intervention name(s): jelly roll
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: All children will undergo laryngoscopy with and without a shoulder roll (randomly assigned) during which photos will be taken of the larynx. The views will be compared using the POGO scale. Contemporaneously, the anesthesiologist's height from the table top to the lateral canthus of left eye.
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: laryngoscopy; pediatric; airway; gel roll; larynx; glottis