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3. Important Notice  Every member who wants to earn CRCE for their participation today must complete the evaluation at the end of today’s program. This includes not only those who registered for this webcast; but those 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 member in their group when completing their evaluation. Instructions to facilitate this are provided in the evaluation instrument.  To accommodate sites where multiple participants will need to use the same computer to complete their evaluation, the evaluation will remain accessible for one hour following the completion of the webcast.  Remember, to earn CRCE your name, AARC member number and the participant name you or your group used to access the webcast must be provided on the evaluation.

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5. Important Notice  Every member who wants to earn CRCE for their participation today must complete the evaluation at the end of today’s program. This includes not only those who registered for this webcast; but those 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 member in their group when completing their evaluation. Instructions to facilitate this are provided in the evaluation instrument.  To accommodate sites where multiple participants will need to use the same computer to complete their evaluation, the evaluation will remain accessible for one hour following the completion of the webcast.  Remember, to earn CRCE your name, AARC member number and the participant name you or your group used to access the webcast must be provided on the evaluation.

7. Important Notice  Every member who wants to earn CRCE for their participation today must complete the evaluation at the end of today’s program. This includes not only those who registered for this webcast; but those 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 member in their group when completing their evaluation. Instructions to facilitate this are provided in the evaluation instrument.  To accommodate sites where multiple participants will need to use the same computer to complete their evaluation, the evaluation will remain accessible for one hour following the completion of the webcast.  Remember, to earn CRCE your name, AARC member number and the participant name you or your group used to access the webcast must be provided on the evaluation.

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9. Important Notice  Every member who wants to earn CRCE for their participation today must complete the evaluation at the end of today’s program. This includes not only those who registered for this webcast; but those 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 member in their group when completing their evaluation. Instructions to facilitate this are provided in the evaluation instrument.  To accommodate sites where multiple participants will need to use the same computer to complete their evaluation, the evaluation will remain accessible for one hour following the completion of the webcast.  Remember, to earn CRCE your name, AARC member number and the participant name you or your group used to access the webcast must be provided on the evaluation.

10. http://www.aarc.org/education/webcast_central/details.cfm#mobile

11. Important Notice  Every member who wants to earn CRCE for their participation today must complete the evaluation at the end of today’s program. This includes not only those who registered for this webcast; but those 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 member in their group when completing their evaluation. Instructions to facilitate this are provided in the evaluation instrument.  To accommodate sites where multiple participants will need to use the same computer to complete their evaluation, the evaluation will remain accessible for one hour following the completion of the webcast.  Remember, to earn CRCE your name, AARC member number and the participant name you or your group used to access the webcast must be provided on the evaluation.

12. The NEW AARC Exam Prep course provides you with: Free access to NBRC CRT and RRT practice exams Your personalized study prescription Over 28 hours of video instruction from top educators, respiratory therapists and physicians Tips for developing excellent test-taking skills Opportunities to earn continuing education credit

13. 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 October 2013 RESPIRATORY CARE Journal Webcast

14. Moderator Shawna Strickland, PhD, RRT-NPS, AE-C, FAARC AARC Associate Executive Director-Education

15. 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.

16. 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

17. 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

18. 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.

19. 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?

20. Is the question relevant?

21. 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.

22. National Hospital Safety Network Ventilator Associated Event (VAE) Surveillance Algorithm 2013

23. Ventilator Associated Events Tier 1 – VAC Tier 2 – IVAC Tier 3 – VAP Respir Care 2013;58(6):990 –1003

24. 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

25. 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

26. ETT innovations for the prevention of VAP Cuff development – Material Polyvinyl chloride (PVC) Polyurethane (PU) – Cuff Shape Cylindrical/barrel Tapered

27. 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

28. Audience question 1.Do you think the study design is appropriate?

29. 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.

30. Results

34. 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?

35. Audience question 2. Do you think the lower VAP Bundle adherence influenced the study results?

36. 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.

37. How should these findings influence practice? Adherence to VAP prevention bundle clearly decreases VAP rate. Insufficient evidence to justify expenditure for special tubes?

38. 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.

39. 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)

40. 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)

41. 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

42. 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.

43. Audience question Do you use special ETTs in your VAP prevention strategy?

44. 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.