04-12859. National Heart, Lung, and Blood Institute (NHLBI); Opportunity for a Cooperative Research and Development Agreement (CRADA) for the Development of a Tilting Bed That Allows Horizontal Positioning and Lateral Rotation

AGENCY:

National Institutes of Health, Public Health Services, DHHS

ACTION:

Notice.

SUMMARY:

The Pulmonary-Critical Care Medicine Branch (P-CCMB) in National Heart, Lung, and Blood Institute (NHLBI) conducts research on lung disease that includes development of new technologies for the prevention of nosocomial pneumonia and ventilator-induced injury.

Ventilator-associated pneumonia is the leading cause of death from nosocomial infection during mechanical ventilation with an endotracheal tube (ETT). The ETT is believed to facilitate bacterial colonization of the lower respiratory tract.

NHLBI has been investigating the role of horizontal orientation of the endotracheal tube and neck on bacterial colonization of the respiratory tract. Current clinical practice is to position the patient semirecumbent by elevating the head of the bed, to reduce gastric regurgitation. NHLBI tested whether horizontal positioning of the ETT and of the trachea combined with intermittent lateral body rotation could facilitate spontaneous removal (without tracheal suctioning) of contaminated respiratory tract secretion, whether bacteria had been introduced into the trachea during intubation or via leakage around the inflated ETT cuff. The ETT and trachea are kept horizontal through a tilting bed that allows lateral body rotation.

NHLBI's studies indicate that maintaining a patient's trachea and tracheal tube in the horizontal plane could be expected to: (1) Obviate the need for tracheal tube suctioning; (2) prevent tracheal/bronchial and pulmonary colonization with oropharyngeal/gastric flora; and (3) in a patient with pre-existing pneumonia, reduce incidence of antibiotic-resistant bacterial infection, as the gastric/oropharyngeal source of such bacteria is eliminated.

This CRADA project is with the Pulmonary and Cardiac Assist Devices Section within P-CCMB in NHLBI. The NHLBI is seeking capability statements from parties interested in entering into a CRADA to further develop, evaluate, and commercialize a tilting bed that allows lateral body rotation. The goals are to use the respective strengths of both parties to achieve the following:

(1) Assistance in conducting clinical trials to determine the performance of the tilting bed in the prevention of ventilator-associated pneumonia and improvement of care of patients intubated and mechanically ventilated; and (2) manufacture of the tilting bed.

The collaborator may also be expected to contribute financial support under this CRADA for personnel, supplies, travel, and equipment to support these projects.

Reference paper: Bacterial colonization of the respiratory tract following tracheal intubation—Effect of gravity: An experimental study. M. Panigada, MD; L. Berra, MD; G. Greco, MD; M. Stylianou, PhD; T. Kolobow, MD: Crit Care Med 2003; 31:729-737.

CRADA capability statements should be submitted to Marianne Lynch, JD, Technology Transfer Specialist, National Heart, Lung, and Blood Institute (NHLBI), Office of Technology Transfer and Development, National Institutes of Health, 6705 Rockledge Drive, Suite 6018, MSC 7992, Bethesda, MD 20892-7992; Phone: [phone]; Fax: [phone]; E-mail: [e-mail]. Capability statements must be received on or before 60 days after Federal Register Notice is published.

Dated: May 26, 2004.

Carl Roth,

Director, Office of Science and Technology.