M ICROCUFF * Pediatric Endotracheal Tubes

1. MICROCUFF*Pediatric Endotracheal Tubes Finally, a cuffed ET tube designed for the pediatric anatomy

2. Issues with uncuffed tubes Airway leak Pressure on cricoid Too small a tube - difficult ventilation1,2 3.0mm 3.5mm 4.0mm Too large a tube - higher risk of subglottic stenosis1,2 Fig: Gerber AC, SPANZA, 2007. 1Fine, Borland. Pediatric Anesthesia, 2004 2Stocks JG. BMJ, 1966

3. Sealing Differences With Uncuffed Tubes Air Leak • Inaccurate monitoring • Higher risk of aspiration • Difficult ventilation • Higher gas flow rate Undersized Tubes Oversized Tubes Glottis • 2.8 times more likely to develop adverse events • Primary cause (92%) for laryngeal trauma in a 65 patient study Crocoid Carina Suominen P et al. Paediatric Anaesthesia, 2006. Holzki J. Paediatric Anaesthesia, 1997. Weiss and Gerber. Pediatric Anesthesia, 2006.

4. Ideal Placement & Features of Cuffed Pediatric Tubes • Short, cylindrical cuff placed near the tracheal tube tip • Cuff placement in the trachea, not in the pressure-sensitive larynx • Anatomically-based depth mark results in correct placement • Tip should rest mid-trachea to avoid endobronchial tip migration • Low cuff pressure to reduce risk of airway trauma Glottis Proper cuff position Crocoid Mid-Trachea Carina

5. Many cuffed ET tubes have an inappropriate design for pediatric use • Too high cuff position, too long cuffs • Absent or unreliable depth marks • No reliable size selection recommendations Cuff position should avoid pressure-sensitive vocal cords and cricoid ring Weiss M, et al. British Journal of Anaesthesia, 2004.

6. The Solution:KIMBERLY-CLARK* MICROCUFF* ET Tube Confidence in a sealed airway Introducing a microthin polyurethane cuff Superior seal at ultra-low pressures Short, distally-placed cuff Ensures correct placement, avoiding repeated intubations Clinically verified, anatomically correct vocal cord depth mark Finally, a cuffed ET tube specifically designed for the pediatric anatomy Dullenkopf A et al. Pediatric Anesthesia, 2004.

7. MICROCUFF* is designed for ideal anatomical cuff placement in the pediatric airway • Short, cylindrical cuff near tracheal tube tip • Correct intubation depth mark • Reduces risk of endobronchial intubation “Depth marks of the newMICROCUFF*paediatric tracheal tube allow adequate placing of the tracheal tube with a cuff-free subglottic zone and without the risk for endobronchial intubation in children from birth to adolescence.” Weiss, et al. British Journal of Anaesthesia, 2005.

8. Advanced microthin polyurethane cuff seals the airway at ultra-low pressure Capillary perfusion pressure in adults is 25-30 cm H2O; considered lower in pediatrics Fig: Dullenkopf et al. Pediatric Anesthesia, 2004. Median cuff pressure to seal the trachea in children aged 2-4 (n=4x20 patients, tube ID 4.0mm). Median cuff pressure. n=4x20 patients. Patient ages 2-4 yrs. Tube ID 4.0mm. “This preliminary investigation suggests that the newMICROCUFF*pediatric tube with ultra-thin high volume-low pressure cuff membrane allows effective tracheal sealing at very low cuff pressures.” Dullenkopf A et al. Pediatric Anesthesia, 2004.

9. MICROCUFF* Endotracheal Tubes provide confidence in a sealed airway • Seals with a cuff, not a rigid tube shaft in the cricoid • Low rate of tube exchange • Positive pressure ventilation with sealed airway • Ensures reliable end-tidal CO2 monitoring • Reduced risk of aspiration of blood and secretions • Low gas flow rates Dullenkopf, et al. Acta Anaesthesiologica Scandinavica, 2005.

10. MICROCUFF* ET tubes allow for safe tracheal intubation and sealing in children • 500 patient study • Only 1.6% had to be reintubated due to incorrect tube size • Only 0.4% experienced post extubation croup requiring short term therapy “The thin-walled polyurethane cuff membrane provides tracheal sealing at lower cuff pressure than reported, probably contributing to the low incidence of postextubation croup.”15 Dullenkopf, et al. Acta Anaesthesiologica Scandinavica, 2005.

11. Evidence-Based Positive Clinical Outcomes Prospective Randomized Multi-Center Study 24 centers across Europe: n = 2,249 patients Avg patient age of 1.9 years (3.0mm-4.5mm tubes used) Tube exchange: 2.1%MICROCUFF, 29.9%uncuffed tubes Post-extubationstridor: 4.38% MICROCUFF, 4.69% uncuffed tubes Cuff pressure to seal the trachea: 10.6 cm H2O Source: ad Swiss Med Wkly 2008:138 (41-42), October 18, 2008

12. MICROCUFF* RAE tubes are clinically verified • n = 166 patients • 97% depth mark was positioned at or below vocal cords • 100% tube tip remained above carina • 100% correct tube size selection "MICROCUFF*allowed safe positioning of the tube cuff and tube tip in almost all children investigated when placed with the tracheal tube bend at the lower incisors or alveolar ridge.” Weiss, M, et al. British Journal of Anaesthesia, 2006.

13. MICROCUFF Pediatric – Top Clinical Articles

14. MICROCUFF ET tubes offer cost benefits • Study by Schmitz compared MICROCUFF*tubes to Sheridan uncuffed tubes “… the increased costs for a cuffed paediatric tracheal tube are more than outweighed alone by savings in Sevorane consumption.”1 1Schmitz et al. Euroanesthesia (ESA) Congress, Munich 2007. * Translated from Euros to Dollars using Apr 2009 exchange rate 1Eu=1.3 Dollar ** Not statistically different