New Mallinckrodt™ SealGuard Evac™ Endotracheal Tube Reduces Late-Onset Ventilator-Associated Pneumonia

Main Category: Respiratory / Asthma
Also Included In: Medical Devices / Diagnostics
Article Date: 04 Feb 2009 - 0:00 PDT

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Covidien (NYSE: COV, BSX: COV), a leading global healthcare products company and recognized innovator in mechanical ventilation and respiratory care devices, introduced the Mallinckrodt™ SealGuard Evac™ endotracheal tube today at the Society of Critical Care Medicine (SCCM) Congress in Nashville. The SealGuard Evac tube incorporates a unique, tapered-shape cuff made from an ultrathin material that virtually eliminates microaspiration of secretions into the lungs while providing secretion drainage through an integrated suction lumen.

The new design and technology have been clinically demonstrated to reduce the incidence of both early- and late-onset Ventilator-Associated Pneumonia (VAP), an important breakthrough for long-term intubation.1 Subglottic secretions drainage (SSD) performed with the SealGuard Evac tube has been shown to reduce VAP by up to 75 percent.2

The SealGuard Evac tube's innovative cuff reduces microaspiration by at least 95%, compared with current high-volume, low-pressure cuffs,3 reducing the risk for complications associated with aspiration. This dramatically improved seal can be accomplished at a 20% lower sealing pressure,3 making it especially well-suited for high-risk cases, such as burn patients or other trauma patients requiring longer ICU stays.

An eight-month randomized clinical trial,1 published in the peer-reviewed journal American Journal of Respiratory and Critical Care Medicine (Vol. 176, 2007), demonstrated that the SealGuard Evac endotracheal tube with polyurethane cuff and subglottic secretion drainage (ETT-PUC-SSD) reduced the incidence of late-onset VAP by 62%, compared with a conventional endotracheal tube with polyvinyl cuff without subglottic secretion drainage. Because it is more often caused by multi-drug resistant organisms, late-onset VAP is associated with significantly higher mortality, antibiotic usage and hospital costs than early-onset VAP.

The study,1 which enrolled 280 patients, was performed at the 24-bed medical-surgical intensive care unit of the Hospital Universitario de Canarias (Tenerife, Spain). Conducted by a team led by Leonardo Lorente, M.D., Ph.D., the trial employed identical measures for the prevention of VAP, such as head-of-bed elevation, stress-ulcer prophylaxis, oral chlorhexidine cleaning and sedation and weaning protocols, in both the test and control groups.

"We believe that the technological advances offered by the SealGuard Evac tube could significantly enhance a healthcare provider's ability to address serious complications that occur during long-term intubation with conventional endotracheal tubes," said Roger Mecca, M.D., Vice President of Medical Affairs for Covidien, manufacturer of the Mallinckrodt SealGuard Evac endotracheal tube. "Two such complications, VAP and tracheal mucosal damage, not only contribute to adverse clinical outcomes, but also have a negative financial impact on the hospital and the health care system."

The SealGuard Evac tube also incorporates an improved suction system design that results in 200% improved suction efficiency, compared with early SSD tubes.4 SSD, also known as continuous aspiration of subglottic secretions (CASS), is a globally recognized intervention in the fight against VAP recommended by the Centers for Disease Control,5 the American Thoracic Society6 and the American Association of Critical-Care Nurses.7

A recently published study8 by Emilio Bouza, M.D., Ph.D., of the Gregorio Marañón University General Hospital in Madrid, Spain, found that CASS significantly decreases antibiotic usage and reduces ICU length of stay and duration of mechanical ventilation in patients intubated for more than 48 hours.

VAP is associated with up to a 27% attributable mortality rate and more than a $40,000 average increase in hospital cost per incidence.9,10 Late-onset VAP has been associated with a 65% attributable mortality rate and over $60,000 in increased cost per patient.1 Dialogue about "never events,"11 public reporting of VAP rates and discussions of changes in reimbursement by the Centers for Medicare & Medicaid Services have brought increased focus on VAP prevention among care providers and hospital administrators.

"With the current focus on reducing hospital-acquired infections and increased bottom-line concerns, the SealGuard Evac endotracheal tube offers a new innovative solution for hospitals' medical and risk management teams that provides superior VAP prevention," added Jim Willett, VP/General Manager, Ventilation and Airway, Covidien.

About Covidien

Covidien is a leading global healthcare products company that creates innovative medical solutions for better patient outcomes and delivers value through clinical leadership and excellence. Covidien manufactures, distributes and services a diverse range of industry-leading product lines in four segments: Medical Devices, Imaging Solutions, Pharmaceutical Products and Medical Supplies. With 2008 revenue of nearly $10 billion, Covidien has more than 41,000 employees worldwide in 59 countries, and its products are sold in over 140 countries. Please visit http://www.covidien.com to learn more about our business.

References

1. Lorente, L. Influence of an Endotracheal Tube with Polyurethane Cuff and Subglottic Drainage on Pneumonia. Am J Resp Crit Care Med, 2007, Sept 13.

2. Smulders, K, can der Hoeven, H, Weers-Pothoff, I, Vandenbroucke-Grauls, C. A randomized clinical trial of intermittent subglottic secretion drainage in patients receiving mechanical ventilation. Chest. 2002; 121: 858-862.

3. 510 (k) clearance letter.

4. Internal testing.

5. Recommendations of CDC and the Healthcare Infection Control Practices Advisory Committee. March 26, 2004/53(RR03); 1-36.

6. American Journal of Respiratory Critical Care Medicine. 171:388-416.

7. American Association of Critical Care Nurses, 2004.

8. Bouza, E. Continuous Aspiration of Subglottic Secretions in the Prevention of Ventilator Associated Pneumonia in the Postoperative Period of Major Heart Surgery. CHEST November 2008, 134 (5).

9. Fagon, JY, Chastre, J, et al. Nosocomial Pneumonia in Ventilated Patients: A Cohort Study Evaluating Attributable Mortality and Hospital Stay. The American Journal of Medicine. 1993; 94: 281-288.

10. Rello, J, Ollendorf, DA, et al. Epidemiology and Outcomes of Ventilator-Associated Pneumonia in a large US database. CHEST 2002; 122:2115-2121.

11. According to the National Quality Forum (NQF), "never events" are errors in medical care that are clearly identifiable, preventable, and serious in their consequences for patients, and that indicate a real problem in the safety and credibility of a health care facility.

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