By: KRYSTLE BREIBECK, AMBER SHIPLEY, LINDSEY TECHANCHUK, NIKKI WEST FACULTY: EMMA KIENTZ COLLEGE OF NURSING, UNIVERSITY OF OKLAHOMA - 2010 Pretesting Foley Catheter Balloon Prior to Insertion Beneficial Technique Or Harmful Standard Practice Current Standard Practice: Assumed BenefitsPretest to ensure balloon is: Symmetrical Inflates without leaking Deflates Current Standard Practice: Identification of Problem Lack of sufficient evidence Discrepancies among healthcare facilities protocol, manufacturers guidelines, and nursing textbooks Negative Outcomes Possible urethral trauma Balloon cuffing, ridges, creases Possible balloon entrapment Scope of the Problem Cochran(2007) 96 million urinary catheters sold worldwide 24 million sold to US hospitals 25% of hospitalized patients PICO Defined POPULATION: Adults (≥ age 18) INTERVENTION: Pretesting the balloon COMPARISON: Not pretesting the balloon OUTCOMES: Better patient outcomes (reduced urethral trauma, creasing, cuffing, and ridges) PICO Question In adult patients receiving a foley catheter, does pretesting versus not pretesting the balloon prior to insertion result in better patient outcomes? Literature Findings Few evidence based articles Dated materials “EveryBody Pray” Literature Findings 2 Evidence-Based Research Studies 3 Non-Evidence-Based Articles Other sources Manufacturers recommendations Procedure manuals Textbook guidelines Literature FindingsRobinson, J. (2003) Evidence Based Research Article Study examined: Which method produces creases and ridges Shows an increase in diameter of catheter Findings: Self-syringe aspiration- no crease or ridge formation Manual syringe aspiration/cutting off inflation valve- crease/ridge formation; increase in diameter size Instilling 0.5 mL water back into the balloon removed creases/ridgesLiterature Findings Barnes, K. E., & Malone-Lee, J. (1986) Evidence Based Research Article Study examined: Lab- three different catheters Clinical- four different catheters Findings : All showed a substantial increase in diameter size The increase in diameter varied between types of catheters. Silicone-coated latex- least increase The findings of this study emphasize the need for extreme care when removing catheters Literature FindingsCochran, S. (2007). Non Evidence Based Article Review of practice guidelines for foley catheterization Findings : Research is limited Collapse of the inflation lumen; increases, ridges or cuff formation atraumatic removal difficult or impossible Self syringe aspiration may prevent collapse of the inflation lumen Literature Findings Gonzalgo, M. L., & Walsh, P. C. (2003). Non Evidence Based Article Findings: Silicone catheters- prone to forming a cuff after manual aspiration Self syringe aspiration reduces the incidence of cuffing If a cuff forms, instill 0.5-1.0 mL of water back into the balloon Literature Findings Smith, J.M. (2003). Non Evidence Based Article Findings: Latex vs. silicone Self-syringe aspiration- reduces urethral trauma Due to the effects of pretesting silicone balloons, recent changes have been made by many* manufacturers Recommends nurses follow manufacturer recommendations Literature Findings McConnell, E. (1995). Non Research Article Findings: Do: When preparing to inflate the balloon after insertion, inflate balloon with dominate hand, slowly. Do Not: Inflate the balloon unless you’ve tested it for leaks before inserting the catheter. Use excessive force to insert the syringe into the inflation lumen. you may push the valve stem too far into the valve. Underinflate the balloon the catheter may slip out of the bladder urine may leak around the catheter shaft Additional Resources Medline Foley Catheterization Tray Insert Material: Pre-Connected with 14 Fr-5 ml Silicone Elastomer Coated Latex Catheter and Drainage Bag Directions for Use Step 6: “Remove poly bag from catheter, inflate and deflate balloon to assure functionality. To inflate balloon, insert tip of water-filled syringe carefully into valve and depress plunger. To deflate, release pressure from plunger and allow water to return to syringe barrel.”Additional Resources Bard Foley Catheterization Tray Insert Materials: not listed Directions for Use: Step 8 “Proceed with catheterization in usual manner. To inflate catheter, simply insert tip of water-filled syringe gently into valve (do not overpenetrate) and depress plunger. Instill entire amount of sterile water.” Additional Resources Bard Clarification Letter “Dear Bard Customer: This letter is to confirm that Bard does not recommend customers inflate Foley balloons prior to use. We believe the practice to be unnecessary, since we test 100% of Foley Catheter balloons as part of our quality assurance process.” Debra Griffith Director, Medical Services and Support C.R. Bard, Inc. (K. Shelton, February 12, 2010) Additional Resources Correspondence with the CDC Via Email “CDC does not have recommendations regarding testing catheter balloons prior to insertion. We do recommend following manufacturer guidelines for the use of their devices.” (CDC-Info, February 27, 2010) Correspondence with the National Association for Continence Via Email Provided a list of references and resources concerning foley catheter management. Did not provide recommendations on topic. (L. Hyatt, March 5, 2010)Additional Resources PERRY AND POTTER (2006, Pg. 1076) “Before Inserting indwelling catheter, a common practice is to test balloon by injecting fluid from prefilled syringe into balloon port.” RATIONALE: “…This is a controversial step. Follow manufacturer’s recommendations. Checking the balloon in this way may stretch the balloon and cause increased trauma on insertion.” SMITH AND DUELL (2008, Pg. 775) “b. Inject 10mL sterile water to inflate balloon to test integrity Rationale: The catheter can fall out if not secure with appropriately inflated balloon….” “d. After testing balloon, pull back on plunger to remove fluid and deflate balloon, leaving syringe in place. --> Rationale: Testing is done to ensure that balloon [the] balloon inflates without leaking.”Summary of Literature: Pros and Cons The studies show a correlation between balloon inflation, and the formation of cuffing, and ridges when deflation occurs. Comparison of Current Practice RecommendationAfter reviewing the literature, research is lacking to support any evidenced –based recommendation. In the interest of the institution, however, recommendations are made to follow the manufacturer’s guidelines for insertion/deflation. Evaluation of Effectiveness Improved patient satisfaction Decreased cases of balloon entrapment and urethral trauma Improved staff satisfaction Suggestions for further study.. Research studies should consider: Cost & prevalence of problem Possible trauma caused by foley catheter balloon cuffing, ridges, and entrapment Additional research areasPrefill  10 mL Cushion 0.5-1 mL Self aspiration vs manual aspiration Catheter Removal slowly vs. quickly Silicone vs. latex Non-research question Why is it that the manufacturer does not specify to pretest or not to pretest on the package insert? References Barnes, K. E., & Malone-Lee, J. (1986). Long-term catheter management: minimizing the problem of premature replacement due to balloon deflation. Journal of Advanced Nursing, 11, 303-307. Cochran, S. (2007). Care of the indwelling urinary catheter: is it evidence based?. J Wound Ostomy Continence Nursing, 34(3), 282-288. Gonzalgo, M. L., & Walsh, P. C. (2003). Balloon cuffing and management of the entrapped Foley catheter. Urology, 61(4), 825-827. McConnell, E.A. (1995). Clinical dos and donts. Nursing, 13. Medline Industries, Inc.. (n.d.). Foley Catheterization Tray. Mundelein, IL Perry, A.G., & Potter, P.A. (2006). Skill 32-2 Inserting a straight or an indwelling catheter. Clinical nursing skills and techniques, 6th edition, 1076. St. Louis, MO: Elsevier Mosby. Robinson, J. (2003). Deflation of a Foley catheter balloon. Nursing Standard, 17(27), 33-38. Smith, J.M. (2003). Indwelling catheter management: from habit-based to evidence-based practice. Ostomy/Wound Management, 49(12), 34-45.