Prospective Clinical Evaluation of the Taperguard Endotracheal Tube

Ventilator associated pneumonia (VAP) is a common complication from tracheal intubation and ventilation. The incidence of this complication is poorly defined but ranges to as high as 21% in surgical intensive care units.1-4 Efforts to reduce these events have evaluated various endotracheal tube (ETT) configurations and changes in clinical practice. Regarding endotracheal tubes, the use of supraglottic suctioning offers patient benefit.5-10 However, a definitive benefit for supraglottic suctioning exists only for patients with prolonged ventilation11. While there may be benefit to supraglottic suctioning for shorter periods of ventilation, the lower incidence of pneumonia in this group makes clinical evaluation less feasible.

The Taperguard tube™ (Covidien, Boulder, CO) is designed to prevent micro aspiration around channels that otherwise form with a barrel-shaped cuff. Laboratory evidence suggests less passage of fluid around the tube then conventional barrel-shaped cuffs (Batchelder, IARS Abstract 2010). Furthermore, a clinical model in pigs suggests less chemical injury from aspiration compared to a barrel shaped cuff (Lichtenthal, Abstract Critical Care 2010, 14(Suppl 1):P229). Human clinical studies are limited to data on reduced dye leakage compared to barrel-shaped cuffs (Mulier, ASA abstracts; D'Haese Acta Anaesthesiol Scand 2013).12

Currently, there is no evidence that patients with brief ventilation such as those undergoing routine surgery may benefit from actual outcomes with this tapered shape compared to regular tubes. Because the incidence of postoperative pneumonia in these patients is lower than those with prolonged ventilation, a large clinical data set would be necessary to evaluate any potential difference.

Since 2011, Oregon Health & Science University (OHSU) has been documenting patient clinical care in a comprehensive point-of-care electronic medical record system (Centricity, General Electric, Fairfield, CT; EPIC, Verona, WI). This information can be collated to provide easy access to co-morbidities, clinical interventions, and ICD-9 discharge codes. In addition, OHSU is part of the National Surgical Quality Improvement Project (NSQIP). OHSU has been a collaborator in this effort since 2006 and collects data on 1,400 patients annually for vascular and general surgery patients (IRB 4621).

The identified incidence of postoperative pneumonia in our NSQIP patients at OHSU is 1.9%. This incidence is slightly below the national NSQIP average and below the risk-adjusted expected rate of postoperative pneumonia. With a large surgical population and access to detailed quality data from our electronic medical record system, OHSU lends itself well to a clinical investigation to improve patient care. As investigators, we have extensive experience with management of data systems for detailing patient outcomes.13