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Important Notice
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Every member who wants to earn CRCE for their participation today
must complete the evaluation at the end of today’s program. This
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members who did not have an opportunity to register for this webcast
and are participating with other registered members. Additionally, those
who did not register must have their participation verified by a registered
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Remember, to earn CRCE your name, AARC member number and
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who did not register must have their participation verified by a registered
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To accommodate sites where multiple participants will need to use the
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October 2013 RESPIRATORY CARE Journal Webcast
This webcast and any accompanying materials are
copyrighted by the American Association for
Respiratory Care (AARC). Any public display, sale,
copy or distribution of the video or materials may
only be undertaken with the prior written consent
of the AARC. Copyright 2013
Moderator
Shawna Strickland, PhD, RRT-NPS, AE-C, FAARC
AARC Associate Executive Director-Education
Program Objectives

Identify the research question of the study.

Identify the study design.

Discuss the main results of the study.

Discuss the implication of the study on patient care.
The Impact of Hospital-Wide Use of a Tapered Cuff Endotracheal
Tube on the Incidence of Ventilator Associated Pneumonia
RESPIRATORY CARE • OCTOBER 2013 VOL 58 NO 10
Steven Holets BS RRT
Assistant Professor of Anesthesiology
Mayo Clinic College of Medicine
• Researchers:
– David L. Bowton, MD, FCCP, R. Duncan Hite, MD,
R. Shayn Martin, MD, Robert Sherertz, MD
• Facility:
– Wake Forest Baptist Hospital, Winston Salem NC
• Nationally ranked academic medical center
• 1000+ beds
• >100 ICU beds
Conflict of Interest
• Investigator initiated study.
– Drs Bowton and Hite partly supported by NIH grants
– Drs. Martin and Sherertz reported no COI
• Industry support (Covidien):
– Provided discounted study device (tapered ETT)
– Money for personnel costs (data collection).
– No involvement in:
• Study design
• Data collection or analysis
• Study conclusions
– Reviewed manuscript prior to submission.
What is the research question?
• Hypothesis:
– Hospital use of a tapered cuff endotracheal tube
would result in a significant reduction in the rate
of Ventilator Acquired Pneumonia (VAP).
• “A research question is essentially a
hypothesis asked in the form of a question.”
• Research question:
– Does the use of a tapered cuff endotracheal tube
reduce the incidence of VAP compared to a
standard cuffed endotracheal tube?
Is the question relevant?
Ventilator Associated Pneumonia VAP
Background
• VAP rate is defined as the number of ventilator-associated pneumonias
per 1,000 ventilator days.
• VAP Incidence 0.0 – 8.5/1000 vent days.
• Attributed mortality 10- 30%
• VAP adds up to $40,000 additional cost to admission.
– Longer ventilator days
– Longer ICU stay
– More antibiotic usage
• Institute for Healthcare Improvement 100,000 lives campaign
– VAP Bundle: HOB elevation, peptic ulcer and deep vein thrombosis prophylaxis, oral care
with chlorhexadine, sedation vacation for weaning readiness.
• Consideration for non-reimbursement by the Centers for Medicare and
Medicaid.
National Hospital Safety Network
Ventilator Associated Event (VAE)
Surveillance Algorithm 2013
Ventilator Associated Events
• Tier 1
– VAC
• Tier 2
– IVAC
• Tier 3
– VAP
Respir Care 2013;58(6):990 –1003
What is known about this subject?
• Increased VAP risk factors associated with ETT
– Impairment of the mucocilliary transport system
– Pooling of secretions above cuff
– Biofilm formation on ETT surface
• Bacterial reservoir
– Tracheal contamination due to microaspiration
•
•
•
•
Folds in cuff along trachea wall
Low cuff pressure
Zero PEEP
Patient movement
ETT innovations for the prevention of
VAP
• Biofilm prevention
– Silver coated
• Reduction in VAP incidence 4.8% vs. 7.5%, (P .03)
• Delayed VAP occurrence (P 0.05)
• No significance in Mortality, ICU, or hospital stay
JAMA 2008 Aug 20;300(7):805-13
– Biofilm removal
• Mucus Shaver®
• Rescue Cath ®
• Secretion pooling
– Subglottic secretion drainage (SSD)
• Suction port above cuff
• Level I evidence
ETT innovations for the prevention
of VAP
• Cuff development
– Material
• Polyvinyl chloride (PVC)
• Polyurethane (PU)
– Cuff Shape
• Cylindrical/barrel
• Tapered
Methods
• Study design:
– Two period observational study
• Inclusion criteria:
– All adult intubated patients in all ICUs
– VAP bundle and data collection standardized
– PNEU2 VAP definition
• Groups:
– Control: Mallickrodt Hi-Lo ® (barrel cuff PVC)
– Intervention: Mallickrodt TaperGuard ® (tapered cuff PVC)
• Power analysis:
– Estimated 6 month trial period to attain adequate number of patients
– Pre study VAP rate 5.8 + 1.47/ 1000 vent days
• Statistical analysis:
– Chi-square tests for proportions, unpaired Students T tests for continuous variables, 2
tailed P value of <0.05 was considered significant
Audience question
1. Do you think the study design is appropriate?
What are the threats to validity of the
design?
• Nonrandomized study
– Quasi-experimental
• Internal validity
– History
• Cannot guarantee that something won’t change between groups
during the course of the study.
• External validity
– Multiple treatment interference
• As multiple treatments are given to the same subjects, it is difficult
to control for the effects of prior treatments.
Results
Results
Results
Results
Discussion
• What do the findings mean?
– In this study, tapered cuff endotracheal tubes were not
significantly better than standard cuffed tubes in VAP
prevention.
– Adherence to VAP bundle may have influenced results.
• Hawthorne effect
– Did it cause an increase in VAP bundle compliance during the
control period that wore off during the intervention period?
• Confounding variables
– Was there some unknown change between groups?
Audience question
2. Do you think the lower VAP Bundle adherence
influenced the study results?
What are the study limitations?
•
•
•
•
Two period observational study.
Single centered.
Reduced compliance to VAP bundle between groups.
Decrease in baseline group VAP 3.29/1000 vent days vs.
5.8/1000 in historically group rendered the study under
powered to answer question.
• Inclusion of transferred patients with standard ETT in
intervention group.
How should these findings
influence practice?
• Adherence to VAP prevention bundle clearly decreases
VAP rate.
• Insufficient evidence to justify expenditure for special
tubes?
How do these findings related to
previous findings from other studies?
• Laboratory studies
– Effect of tracheal tube cuff shape on fluid leakage across the
cuff: an in vitro study British Journal of Anaesthesia 105 (4): 538–43 (2010)
• Results: Greater leakage in conventional cuff PVC vs. conventional
PU vs. tapered PU (P 0.01)
– Benchtop study comparing leakages across cuffs of three
endotracheal tubes Critical Care 2013, 17(Suppl 2):P152 (abstract)
• Results:
• Tapered PU cuff and micro PU cuff outperformed conventional PVC
cuff under all scenarios (P < 0.01)
• Maintaining Pcuff > 20cmH20 decreases leakage
• Loss of PEEP increases leakage in conventional cuff PVC regardless of
cuff pressure.
How do these findings relate to
previous findings from other studies?
• Animal studies
– Do tracheal tubes prevent microaspiration? Brit J Anaesthesia 2011;107(5):821-822
• 14 anesthetized pigs intubated with Hi Lo standard cuff or SG tapered
cuff ETT
• Dyed saline instilled above cuff
• Autopsy examination of airways for leakage
• Results: Less dye leak with tapered cuff 1/6 vs. standard cuff 7/7 (P
0.005) (reduced micro-aspiration)
How do these findings related to
previous findings from other studies?
• Human studies:
– Effect of positive expiratory pressure and type of tracheal cuff on the
incidence of aspiration in mechanically ventilated patients in an
intensive care unit Crit Care Med 2008; 36(2):409-413
.
• 40 Intubated patients: 20 HiLo PVC tube, 20 Sealguard PU tube had dye
instilled above cuff and bronchscopy to examine for leakage at different
timepoints
• Results: All HL cuffs leaked sooner than SG, PEEP improves sealing
– Endotracheal tube with tapered-type cuff for preventing VAP: a
randomized clinical trail Critical Care March 2013, 17(Suppl 2):P153 (abstract)
• 289 patients receiving mechanical ventilation > 48 hours
• Compared conventional cuff PVC with SSD vs. Tapered cuff PVC with SSD
• Results: No difference in VAP rate 21.7% (P 1.0)
What additional work is needed in this
area?
• Large multi-center randomized controlled trial (RCT).
– Prospective design
– Sufficient power to answer the question
– Allow subgroup analysis
• Challenges:
• Change in practice over time
• Strict adherence to study protocol
– VAP bundles, Ventilator management
• Cost
– Equipment, personnel
Editorial
Too Passive to Prevent Ventilator-Associated Pneumonia
Juan Felipe Fernandez MD Marcos I Restrepo MD MSc
• Preventing cuff leakage may not be enough to reduce VAP.
• Newer model of tapered tube with subglottic suction may work
better.
• Higher adherence to VAP bundle (96% control group) may have
decreased VAP rate influencing results.
• Patients with contraindications to VAP bundle adherence may
have bias results.
• Monitoring VAP rate and adherence to VAP bundles should be
priority before considering ETT technologies.
Audience question
• Do you use special ETTs in your VAP
prevention strategy?
Conclusions
• What are the authors’ conclusions?
– In the setting of high adherence to a VAP prevention bundle, the use
of a tapered cuff ETT was not associated with a significant reduction in
VAP rate.
• How do you think this should affect practice?
– Concentrate on proven interventions, VAP bundle.
• What is the take-home message?
– Laboratory findings do not necessarily transfer to improved clinical
outcomes.
– Negative studies provide important information.
– Highlights some of the difficulties of conducting a clinical trial.
– Further research is needed before the question can be answered.

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