Comparison of AirTraq Laryngoscope to Macintosh Laryngoscope for Intubation of Patients With Potential Cervical Spine Injury
Condition: Trauma
MeSH terms: Spinal Injuries
Study type: Interventional

Summary: 
      Intubation is frequently required for trauma patients as part of the resuscitative effort.
      When the stability of the cervical spine is unknown, the potential for spinal cord damage
      during intubation is significant; the question of the safest intubating technique has not
      been resolved. Previous Studies have evaluated Macintosh Laryngoscopy, Bullard Laryngoscope,
      face mask ventilation, fibre-optic guided oral and nasal intubation, esophageal Combitube®,
      Laryngeal Mask Airway® (LMA), and Intubating Laryngeal Mask Airway® (ILMA) use with respect
      to cervical spine movement. Our previous study evaluated the Intubating Lighted Stylet
      (Lightwand®) and GlideScope® versus the Macintosh Laryngoscope.

      Another method of securing endotracheal intubation, approved and in routine use, is the
      AirTraq® videolaryngoscope (ProMedic, Inc, Bonita Springs, FL, USA). The AirTraq
      videolaryngoscope is a videolaryngoscope with an external video display of the glottic
      opening and an endotracheal tube track to guide the ETT through the vocal cords
      (www.airtraq.com). When a clear view of the vocal cords is obtained, the endotracheal tube
      may be advanced into the trachea. This technique can be performed rapidly and safely and
      there is the perception that it involves less cervical spine movement than direct
      laryngoscopy.

      We propose to study the AirTraq videolaryngoscope to determine if its use would result in
      reduced cervical spine movement during intubation.
    

Detailed description: 
      With the surgeon's consent, informed and written consent will be ob¬tained 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, as well as
      height, weight, and age.

      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 dur¬ing laryngoscopy.

      After standard pre-oxygenation, anesthesia will be induced in routine fashion with 2 3 mg/kg
      propofol and 2-5 mcg/kg fentanyl; rocuro¬nium 0.8 mg/kg will be administered to effect muscle
      paralysis. The patient will be then be ventilated with 100% O2 via bag/mask for 3 minutes.
      (Oxygenation with 100% O2 provides an oxygen reservoir for at least 5 minutes while
      laryngoscopy is completed.) This is the standard of care in anesthesia.

      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 AirTraq videolaryngoscope, in random order as determined by the
      envelope. Between laryngoscopies, the patient will be ventilated with sevoflurane in 100%
      oxygen.

      Male patients will be intubated with an 8.0 mm inner diameter endotracheal tube (ETT) and
      women with a 7.0 mm or 7.5 mm ETT at the discretion of the anesthesiologist.

      For AirTraq videolaryngoscopy, the AirTraq will be inserted and a view of the vocal cords
      will be obtained. The ETT will be advanced through the track until the tip of the ETT is
      visible at the glottic opening and then removed with the AirTraq videolaryngoscope.

      For direct Macintosh laryngoscopy, a size 3 laryngoscope blade will be recommended in all
      patients, but the anesthesiologist may choose another size if deemed necessary. 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 cervical spine movement.

      Laryngoscopy time will be defined as the time from when the laryngoscope blade or AirTraq
      videolaryngoscope 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-Lehane score, representing the degree of glottic exposure, of the larynx will be
      recorded for all patients. Blood oxygen saturation, heart rate, and blood pressure will be
      recorded every minute during the study.

      To minimize inter-operator variability, all bag-mask ventilation, laryngoscopy, and
      intubation will be completed by one person.
    

Intervention name(s): AirTraq
Intervention type(s): Device
Intervention description(s): Laryngoscopy with AirTraq
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Cervical Spine