Covidien, a leading global healthcare products company, announces that the Mallinckrodt TaperGuard endotracheal tube provided 100 percent protection from intraoperative microaspiration in a recently released study of morbidly obese patients undergoing gastric bypass surgery. The study was conducted by Dr. F. Van den Brande and colleagues at the Department of Anesthesiology at Sint Jan Brugge-Oostende in Bruges, Belgium.
Microaspiration is the leakage of fluid and secretions past the endotracheal tube cuff into the lungs a common problem in intubated patients that could lead to pulmonary complications, including postoperative pneumonia and ventilator-associated pneumonia (VAP). By providing an effective fluid seal, the TaperGuard endotracheal tube, designed with a taper-shaped cuff, reduces the risk of microaspiration, and helps to improve patient safety.
In Dr. Van den Brandes study of 63 patients undergoing the Roux-en-Y gastric bypass procedure, 31 patients were randomly selected for intubation with the TaperGuard endotracheal tube; 32 patients were randomly selected for intubation with a conventional endotracheal tube using a high-volume, low-pressure cuff. The study participants had a body mass index above 40 (morbidly obese), and were ventilated with 5 cm positive end-expiratory pressure (PEEP) to maintain lung volume during surgery.
None of the 31 patients intubated with a TaperGuard endotracheal tube had any evidence of microaspiration, while 13 of 32 patients intubated with the conventional high-volume, low-pressure Mallinckrodt Hi-Lo endotracheal tubes had evidence of microaspiration.(1)
The protection against leakage seems to be a result of the innovative shaped cuff of the TaperGuard endotracheal tube, Van den Brande says. In our study, the tapered cuff offered more effective protection against microaspiration compared to conventional barrel-shaped cuffs. That protection is critical, particularly in this patient population, since obese patients are particularly prone to surgical complications.
A 2009 study in the New England Journal of Medicine showed that 22.4 percent of Medicare patients, who accounted for the estimated $17.4 billion in unplanned rehospitalization charges, were surgical patients. Pneumonia was the number two reason for rehospitalization. Abdominal surgery patients in particular, such as those undergoing gastric bypass, have been shown to be a high risk group for postoperative pneumonia.
Covidien also offers the TaperGuard Evac tube, which combines the innovative taper-shaped cuff design with Mallinckrodt Evac technology. When the TaperGuard cuff is paired with Mallinckrodt Evac technology, the TaperGuard Evac endotracheal tube reduces microaspiration compared to the Hi-Lo endotracheal tubes while enabling the removal of secretions that may collect above the cuff through an integrated suction lumen.
The advanced-design TaperGuard tube can help reduce many of the risks associated with post-intubation pulmonary complications, which could mean greatly improved patient outcomes and substantial cost-savings for healthcare facilities, said Douglas Hansell, MD, MPH, chief medical officer and vice president of respiratory and monitoring solutions for Covidien. Covidien continues to refine and improve its existing products to improve patient outcomes.
Reference: 1. Covidien provided research support for this study. These results may vary depending on situational circumstances. The TaperGuard cuff has a 510(k) claim that it will seal an average of 90 percent better than the Mallinckrodt Hi-Lo cuff.