Comparison of GlideScope Specific Stylet to Malleable Stylet for GlideScope Intubation
Condition: Intubation, Endotracheal
Study type: Interventional

Summary: 
      The GlideScope video laryngoscope (Verathon) is an intubating device that uses a
      high-resolution camera embedded into a plastic laryngoscope blade. An LED provides
      illumination. The GlideScope often provides a good laryngoscopic view, but passing the
      endotracheal tube (ETT) through the vocal cords is sometimes difficult. Because of the 60
      degree anterior curvature of the GlideScope's blade, ETT's must have stylets inserted so that
      the ETT distal tip can be positioned anteriorly. Various authors have recommended different
      angles of the ETT to optimally place it into the trachea. Previous study demonstrated that 90
      degree sharp bend was both faster and subjectively easier in a heterogeneous group of
      intubators. With the introduction of a rigid GlideScope Specific Stylet by the manufacturer,
      the question arises as to the the best configuration of stylet for the ETT. Therefore, this
      prospective, randomized, single-blinded trial is proposed.

      The null hypothesis is that there will be no difference between the GlideScope Specific
      Stylet and the standard malleable stylet.
    

Detailed description: 
      Purpose:

      To determine the optimum angle of curvature of an endotracheal tube when used with a
      GlideScope in order to intubate in the most efficient fashion.

      Methods:

      Groups: A) 90º curvature, malleable stylet B) shallow curvature, rigid GlideScope Specific
      Stylet

      Hypothesis:

      The null hypothesis is that there is no difference in the primary outcome (time to
      intubation). i.e. we hypothesize that the time to intubate is not related to the shape of the
      endotracheal tube. The control group will be arbitrarily assigned to the 90º group that was
      the preferred option in a previous trial.

      Primary Endpoint:

      1) Time to intubation (seconds).

      Written informed consent will be obtained by one of the study investigators, and a copy will
      be given to each participant. Written informed consent will also be obtained from the
      operator of the GlideScope. After consent, randomization will occur by selecting the next
      consecutive envelope.

      There are three distinct anesthesia providers involved in the conduct of this study, as
      follows:

        1. "operator" - person performing the intubation

        2. "timer" - person timing the outcome (one of the co-investigators)

        3. "shaper" - person who ensures that the angle and stylet of the tube matches the group to
           which the patient was allocated

      Because the person intubating must be blind up until the time at which the tube is to be
      used, the unopened envelope will be taken to a third anesthesia provider, who will prepare
      the ETT with stylet in an area that is not visible to the person performing the intubation or
      to the person timing the intubation. The person performing the intubation will specify what
      size of tube they wish to use. This will most commonly be 7.5 mm internal diameter (ID) for a
      female and 8.0 ID for males, but the operator is free to use whatever size they feel is
      appropriate. The tube size selection will take place before unblinding so the group
      allocation cannot affect the decision of tube size.

      "Group A" ETT's will be shaped with the aid of a standard malleable stylet (Rusch 14 Fr) that
      has been lubricated with single-use water-soluble lubricant. "Group B" ETT's will be
      instrumented with the GlideScope Specific Stylet, with identical lubricant. The prepared tube
      will then be concealed under a standard green OR towel and brought to the operating room
      (OR). This tube will be placed close to the patient's head so that it is readily accessible.

      Data Collection

      In the OR, the GlideScope will be turned on at least 60s before use to prevent fogging. The
      patient will be cared for in the usual fashion with respect to monitoring and induction of
      general anesthesia. Muscle relaxation will be used, and the agent used is at the discretion
      of the operator. After induction of anesthesia, bag-mask ventilation will be used in the
      usual fashion until the operator decides to proceed to laryngoscopy with the GlideScope. The
      operator will remain blinded to the group allocation until after the laryngoscopic view has
      been obtained with the GlideScope, where upon he will be handed the endotracheal tube.

      The timer (who cannot see the tube under the green towel) will watch the operator until the
      GlideScope is in the patient's mouth, start the timer, and then turn 180º to face the
      anesthetic monitor. The timer will not be able to see the ETT, stylet, or curvature because
      he will be facing the screen.

      Timing will continue until end-tidal CO2 of at least 30 mmHg is seen on the anesthesia
      monitor, at which point the data collection form will be filled out, and the study protocol
      will be finished. (The time to intubation will be recorded to the nearest tenth of a second.)
      If the operator fails to intubate within 3 attempts or 150 seconds, the intubation will be
      noted as a failure, and the ultimately successful means of securing the airway will be
      recorded.

      If oxygen desaturation (as recorded by pulse oximetry) below 95% occurs, then the patient
      will be ventilated in the usual fashion to ensure oxygenation, and re-attempting intubation
      using the GlideScope may proceed, but the timing will continue, and the same limits to
      successful intubation (within 3 attempts or total of 150s) will apply. Between attempts, the
      tube may be re-shaped by the operator if a malleable stylet is used and either the original
      curvature has been lost or the operator feels that another curvature would be preferred.

      Discontinuation Criteria

      If the oxygen saturation falls below 90% occurs at any point, the protocol will stop
      immediately, and management will proceed in the normal fashion at the discretion of the
      attending anesthesiologist, which could involve immediate intubation using the GlideScope or
      other intubation device, or ventilation using a mask or laryngeal mask airway. If, at any
      time, the attending anesthesiologist believes there is any risk to the patient because of the
      study protocol, the protocol will be terminated and normal anesthetic care will continue.
    

Intervention name(s): GlideScope Specific Stylet
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: GlideScope; Stylet