Evaluation of Supralaryngeal Airway Removal During Initial Resuscitation of the Trauma Patient



Status:Completed
Healthy:No
Age Range:Any
Updated:4/21/2016
Start Date:August 2006
End Date:July 2010

Use our guide to learn which trials are right for you!

In the trauma setting, if a patient has arrived in the trauma bay with an ETC/King LT-D in
place, it has traditionally been immediately exchanged out for an ETT upon arrival. The
timing of the exchange has never been adequately defined in terms of safety. This study is a
prospective clinical trial designed to evaluate the safety of supralaryngeal, ETC/King LT-D
tube, exchange [either in the operating room (if immediate surgery is required) or after
stabilization in the trauma bay/intensive care unit according to the protocol adapted
previously by UWHC.

The esophageal tracheal combitube (ETC) was first marketed in 1987 by Frass, Frenzer, and
Zahler as an alternative airway to traditional endotracheal intubation. The combitube is a
polyvinyl chloride double lumen supraglottic airway that can be placed blindly, quickly, and
with minimal training. The device is available in two sizes, 37F for small adults (4-6 feet
tall) and 41F for larger adults (up to 198 cm height). It is now widely used in Wisconsin
for the pre-hospital airway management algorithm for trauma patients.

The combitube is designed with two lumens including a pharyngeal lumen (blind distal end and
a blue proximal end which allows communication with the airway via holes positioned just
above the lower pharynx) and a tracheal lumen (clear, short proximal portion and open distal
portion). The device also has two balloons to allow for adequate ventilation and oxygenation
while minimizing the risk of aspiration. The oropharyngeal balloon is located above the
pharyngeal perforations and when inflated (85 - 100 mL of air) seals the oral and nasal
cavity. The distal balloon is positioned just above the distal tracheal lumen opening and
will seal either the esophagus or the trachea depending upon the positioning when inflated.

The King LT-D is designed with one lumen, two ventilation apertures located between two
inflatable cuffs. The distal cuff/balloon seals the esophagus. The proximal cuff/balloon
seals the oropharynx. Ventilation occurs through the proximal end of the tube.

Multiple clinical trials have been undertaken examining the safety and efficacy of the ETC &
King LT-D used in the pre-hospital setting. In general, the ETC device has shown superiority
to the laryngeal mask airway (LMA), oral airway/bagged mask ventilation, and the pharyngeal
tracheal lumen airway in terms of success rate of insertion, ventilation, and complication
rates. In-hospital use, including use in elective operative cases up to 6 hours duration and
in cardiac arrest necessitating CPR, has been studied in a more limited fashion. However,
small clinical trials have supported the use of ETC & King LT-D as a first line rescue
airway when ETT is not possible. In addition, several studies have shown equivalence of
ventilation and oxygenation between ETT and ETC used in CPR, in the operating suite, and in
the ICU setting. However, most clinicians still view the supralaryngeal ETC/King LT-D as
primarily rescue airways.

Although technically possible to maintain an airway with the supralaryngeal ETC/King LT-D,
endotracheal intubation has been the gold standard. In the trauma setting, if a patient has
arrived in the trauma bay with a supralaryngeal airway in place, it has traditionally been
exchanged out for an ETT during the primary survey (initial assessment). This exchange is
possible using a number of techniques widely described in the literature. Although the
skilled anesthesiologists reportedly can do this exchange safely and rapidly according to a
limited number of clinical trials, the safety of the exchange during the primary survey and
initial resuscitation of the trauma patient has not been well documented.

This study is a prospective clinical trial designed to evaluate the exchange of the
supralaryngeal airway immediately upon arrival to the trauma bay according to the UWHC
previously adopted protocol.

Inclusion Criteria:

- All trauma patients arriving in the trauma bay with an ETC (combitube) or King LT-D

Exclusion Criteria:
We found this trial at
1
site
Madison, Wisconsin 53792
(608) 263-2400
University of Wisconsin In achievement and prestige, the University of Wisconsin–Madison has long been recognized...
?
mi
from
Madison, WI
Click here to add this to my saved trials