Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02450929 |
| Other study ID # |
Taperguard |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
December 12, 2012 |
| Est. completion date |
December 31, 2016 |
Study information
| Verified date |
August 2018 |
| Source |
Oregon Health and Science University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
This protocol is designed to determine if a transition from barrel-shaped cuff designs to the
Taperguard endotracheal tube (ETT) reduces the incidence of postoperative pneumonia in a
prospective evaluation of a large general, vascular, orthopedic, urologic and neurologic
surgical population. The protocol was originally developed as a quality assurance project to
evaluate a practice change that took place December 1, 2012. Data regarding postoperative
pneumonia and related factors will be reviewed for the 18 months prior to the practice change
and compared to data from the 14.5 months following the change. Since the results may be of
interest to a wider audience, we are converting the project to a research study that may be
published in the future.
The study will include data from all adult patients who had surgery at OHSU between June 1,
2011 and February 15, 2014. We anticipate that we will enroll approximately 40,000 subjects
(at least 22,000 in the pre-intervention group and at least 16,000 in the post-intervention
group). Data will be gathered from the OHSU electronic medical record system (Centricity and
Epic).
6. A multiple logistic regression analysis will be employed to determine the rates of
pneumonia between the use of a standard barrel-cuff designed ETT and the Taperguard ETT for
the defined group of surgical patients. The regression analysis would be adjusted for
confounding variables including ASA status, age, use of paralytic, RSI with cricoid pressure,
weight, pre-existing lung disease.
Description:
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
On December 1, 2012, OHSU instituted a practice change to transition from endotracheal tubes
with a barrel-shaped cuff design to the Taperguard tube for all surgical patients. A quality
assurance program was set up to monitor patient outcomes, including postoperative pneumonia,
before and after this practice change. The investigators have developed this protocol as an
expansion of the quality assurance program, to determine how this practice change has
affected patient outcomes.
This study is designed as a chart review to collect data from all adult surgical patients at
OHSU for the 18 months prior to the practice change (June 1, 2011 - November 30, 2012) and
compare it to data for all adult patients having surgery during the 14.5 months following the
practice change (December 1, 2012 - February 15, 2014). Subjects will be excluded if
anesthesia was provided using a Hi-Lo, double lumen, reinforced, or laser endotracheal tube
or a laryngeal mask airway. Data will be collected from the OHSU electronic medical records
(Centricity and EPIC). We will gather all ICD-9 discharge coding related to postoperative
pneumonia and link it to pertinent information from the patient's anesthesia record,
including demographic and surgical case information. Postoperative pneumonia will be defined
using the NSQIP definition (listed at the end of this protocol).
We anticipate that we will enroll approximately 40,000 subjects in the study. The identified
incidence of postoperative pneumonia at OHSU currently is 1.9%. A power analysis was
conducted to determine a meaningful sample size in light of a predicted improvement in
pneumonia outcomes. To demonstrate a risk reduction from 1.9% to 1.5% with 80% power and 0.05
significance, 22,000 patients would need to be enrolled in the pre-intervention group and
16,000 patients in the post-intervention group.
The primary source of data for this study is the electronic medical record. The NSQIP
database may be used for comparison and verification of the data collected.
During the study period, there have been no active institutional changes to address
postoperative pneumonia and none are anticipated in the near future. Anesthesia techniques
are not undergoing any major changes to address pneumonia outcomes and compliance with
prophylactic antibiotic administration is optimized at OHSU. Similarly, the intensive care
units implement a "bundle" practice to reduce pneumonia that includes GI prophylaxis,
tracheal suctioning, elevated head of bed positioning, sedation vacation with spontaneous
breathing trial once a day, and targeted antibiotic therapy.
A multiple logistic regression analysis will be employed to determine the rates of pneumonia
between the use of a standard barrel-cuff designed ETT and the Taperguard ETT for the defined
group of surgical patients. The regression analysis would be adjusted for confounding
variables including ASA status, age, use of paralytic, RSI with cricoid pressure, weight,
pre-existing lung disease.
While patient benefit from potential reduced micro aspiration may be assumed from preliminary
data, additional costs associated with this new technology are not warranted without evidence
of patient care benefit or reduced patient care costs. The ultimate outcome desired when
selecting endotracheal tube and ventilation strategy is a reduction in lung injury,
morbidity, and reduced costs. Because this new technology offers potential benefit, it is
imperative that a large-scale clinical study confirm the hypothesis that pneumonia is reduced
by altering cuff design before a change in practice can be advocated. Estimates of
cost-savings achieved from potential positive data can be constructed. In this manner, the
Taperguard tube has potential to demonstrate savings for hospitals and improved patient care.
