Intubation Clinical Trial
Official title:
An Evaluation Of The Rapid Airway Management Positioner (RAMP) In Obese Patients Undergoing Gastric Bypass Or Laparoscopic Gastric Banding (Lap-Band) Surgery
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.
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.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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