[Federal Register Volume 69, Number 110 (Tuesday, June 8, 2004)]
[Notices]
[Page 32031]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-12859]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


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.

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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: (301) 594-4094; Fax: (301) 594-
3080; E-mail: [email protected]. 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.
[FR Doc. 04-12859 Filed 6-7-04; 8:45 am]
BILLING CODE 4140-01-M