Evaluation of the Rapid Airway Management Positioner
Condition: Endotracheal Intubation; Rapid Airway Management Positioner
Study type: Interventional

Summary: 
      The purpose of this study is to determine if the Rapid Airway Management Positioner (RAMP,
      AirPal, Center Valley, PA) is a useful positioning device for direct laryngoscopy and
      tracheal intubation in obese patients undergoing gastric bypass or laparoscopic gastric
      banding surgery.
    

Detailed description: 
      The cannot intubate, cannot ventilate case is the most dangerous of situations, and being
      able to foresee, prevent, and prepare for such difficulties is the task of every
      anesthesiologist. Difficult mask ventilation is predicted by a number of factors, including
      obesity.1 Appropriate bag-and-mask ventilation necessitates a patent airway. An increased BMI
      is associated with a reduced posterior airway space behind the tongue's base as well as a
      quick development of hypoxemia from reduced functional residual capacity in improper mask
      ventilation.1 Proper head and neck positioning to establish the patent airway then is
      especially important.

      There is an increased risk of difficult laryngoscopy among obese patients compared with
      subjects with normal body mass index.2,3 Optimal laryngeal view during laryngoscopy can be
      facilitated with proper head and neck positioning, including slight elevation of the head,
      neck flexion relative to the chest, and extreme atlanto-occipital extension.4 The "ramped"
      position, where the patient's ear is horizontally aligned with their sternal notch, has been
      found to be superior to the standard "sniffing" position, 7-cm occiput elevation, during
      direct laryngoscopy in morbidly obese patients.4

      Additionally, there are increased difficulties and risks for tracheal intubation in obese
      patients versus normal-weight patients. Studies have found that chances for a successful
      first attempt at oral intubation decrease as patient weight increases.6,7 Improving
      visualization of laryngeal structures will increase the likelihood of successful tracheal
      intubation, as increasing the percentage of glottic opening is correlated with the number of
      intubation attempts, as well as the need for rescue intubation devices.8

      It is estimated that endotracheal intubation is performed on approximately 8 million patients
      per year in the United States. Of these endotracheal intubations, approximately 80% are
      performed by direct laryngoscopy with transoral placement of the endotracheal tube (ET) into
      the trachea. There is fairly uniform reporting of the incidence of failed intubation in the
      literature; it occurs in approximately 0.05% or 1:2230 of surgical patients and in
      approximately 0.13% to 0.35%, or 1:750 to 1:280, of the obstetric patients.9,10 The incidence
      of unsuspected difficult intubation is estimated to be higher at 3%. One factor that
      contributes to difficult intubation is poor visualization, and difficult laryngoscopy is
      highly correlated with poor laryngeal exposure.11

      The Rapid Airway Management Positioner (RAMP) is designed to optimize visualization during
      direct laryngoscopy by placing the patient into the proper head-elevated laryngoscopy
      position (HELP). In morbidly obese patients, achieving this position is important,12 and
      requires a great deal of support under the head and shoulders that could not be performed
      singlehandedly.13 The RAMP is an easy-to-use, quick device, taking an average of 56 seconds
      to place and inflate.14

      The RAMP has great potential in obese patients. Pre-positioning also helps increase the
      desaturation safety period for morbidly obese patients.15 Rescue ventilation techniques are
      facilitated by the HELP position, when the head and neck are elevated above the chest and
      abdomen. The airway is therefore more isolated and easier to work with, and less positive
      airway pressure is needed when the weight of the abdomen is away from the diaphragm.
      Currently, placing a patient on top of stacked blankets is common and can create the HELP, or
      "ramped" position, 5 but also causes variable and unstable results. We suspect that by
      providing a better laryngeal view, the RAMP may help decrease the incidence of tissue trauma
      associated with intubation, and intubation may be achieved more quickly in a population that
      is known to be difficult.
    

Intervention name(s): Laryngoscopy with RAMP; Laryngoscopy without RAMP
Intervention type(s): Device; Device
Intervention description(s): inflatable positioning ramp; Laryngoscopy without RAMP
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Endotracheal Intubation; Rapid Airway Management Positioner