Coaxial Everting Membrane Catheter Bronchoalveolar Lavag

Period of Performance: 08/01/2006 - 07/31/2008

$198K

Phase 1 SBIR

Recipient Firm

Bioengineering Consultants, LTD
Charlottesville, VA 22903
Principal Investigator

Abstract

DESCRIPTION (provided by applicant): Project Summary/Abstract: Ventilator-Associated Pneumonia (VAP) is pneumonia that develops in a mechanically ventilated patient later than 48 hours after intubation. The longer a patient is intubated, the greater the chance that pneumonia will develop. Pneumonia is the second most common nosocomial infection in critically ill patients, impacting 27% of all critically ill patients and is the leading cause of death from hospital-acquired (nosocomial) infections. 86% of nosocomial pneumonias (NP) are associated with mechanical ventilation and are termed ventilator associated pneumonia. Between 250,000 and 300,000 cases per year occur in the United States, alone which is an incidence rate of 5-10 cases per 1,000 hospital admissions. An important diagnostic procedure is a culture of the sputum or lung aspirate for accurate diagnosis and therapeutic evaluation of the cause of the pneumonia. However, sputum (lung, trachea or oropharyngeal secretions) is often contaminated by saliva, oropharyngeal organisms and squamous cells that are deposited on the catheter during passage through the mouth and trachea. There are no commercially available catheter systems that allow for the collection of uncontaminated sputum samples for the diagnosis of pneumonia. The total commercial market for this type of device is approximately 250,000 units at a retail cost of $100 per device. The specific aim of this proposal is to design, prototype and evaluate an innovative coaxial everting membrane catheter for bronchoalveolar lavage (referred to as the CEMBAL catheter and brush) for accurate sputum collection for diagnosis of pneumonia. It is our hypothesis that the CEMBAL catheter system will allow the quick and easy collection of uncontaminated sputum for better management of the VAP patient. We propose to compare the CEMBAL catheter with the CombiCath(r) and a standard suction catheter in a bench-top model to demonstrate the ability of the catheter to retrieve uncontaminated samples. Project Narrative: Ventilator-Associated Pneumonia (VAP) is the second most common nosocomial infection in critically ill patients, impacting 27% of all critically ill patients and is the leading cause of death from hospital-acquired (nosocomial) infections. The proposed device will provide for the uncontaminated sampling of the lower lung aspirate for a more accurate diagnosis of the organism causing the pneumonia.