[Federal Register: March 2, 2004 (Volume 69, Number 41)]
[Notices]
[Page 9830-9831]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02mr04-55]
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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 Novel Endotracheal Tube Cleaning System and Improved
Endotracheal Tube Design and Conditions of Use
AGENCY: National Institutes of Health, Public Health Service, 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.
The great majority of mechanically ventilated patients are
intubated with an endotracheal tube (ETT). Millions of endotracheal
tubes are used in the United States every year. VAP is the most common
nosocomial infection in Intensive Care Unit (ICU) patients, afflicting
8 to 28% of patients receiving mechanical ventilation (MV). VAP is also
the leading cause of death from hospital-acquired infection. NHLBI data
indicate that improved design of the ETT and conditions of use can
significantly reduce the incidence of VAP.
After a few days of MV, the lumen of an ETT is coated with a thick
bacterial biofilm, which is a major source for bacterial colonization
of the lower respiratory tract, and VAP. Accumulation of mucus/
secretions on the interior of the ETT effectively lowers the cross
section of the ETT and increases significantly the work of breathing in
intubated patients, who then require increased MV support, with
prolonged intubation and ICU stay.
In experimental studies, NHLBI showed that it is possible to
prevent bacterial colonization of the trachea, bronchi, lungs, ETT, and
ventilator circuit over a prolonged time of MV (168 hours), to decrease
ETT resistance and therefore the work of breathing, and to avoid
tracheal mucosal injury or decrease mucus-clearance following inflation
of the cuff, when: (1) The ETT is cleaned with a novel cleaning system
to remove all mucus from the lumen of the ETT; (2) the ETT is coated
with bactericidal agents (silver-sulfadiazine with or without
chlorhexidine in polyurethane); (3) low resistance thin-walled ETT is
used; (4) the cuff of the ETT is replaced with gills; and (5) the ETT
and trachea are kept horizontal, through a tilting bed that allows
lateral body rotation.
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 new design and management of ETTs
in patients intubated, and mechanically ventilated, that include a
novel ETT cleaning device and a low resistance ultra-thin ETT coated
with bactericidal agents, with gills. The goals are to use the
respective strengths of both parties to achieve the following:
(1) Preparation of an IDE for FDA approval for the coating of the
tube and of the mucus cleaning system;
(2) Assistance in conducting clinical trials to determine the
performance of this multi-task strategy in the prevention of
Ventilator-associated Pneumonia and improvement of care of patients
intubated and mechanically ventilated;
(3) Manufacture of the ultra-thin coated ETT with gills,
bactericidal coated tubes, and the cleaning system.
The collaborator may also be expected to contribute financial
support under this CRADA for personnel, supplies, travel, and equipment
to support these projects.
The tilting bed noted in the experimental studies above will be the
subject of a concurrent CRADA announcement issued by NHLBI. Interested
parties are encouraged to inquire using the contact information below.
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: Lynchm@nhlbi.nih.gov. Capability statements must be
received on or before May 3, 2004.
The NHLBI has applied for patents claiming the core of the
technology. Non-exclusive and/or exclusive licenses for these patents
covering core aspects of this project are available to interested
parties.
Licensing inquiries regarding this technology should be addressed
to Michael Shmilovich, JD, Technology Licensing Specialist, Office of
Technology Transfer, National Institutes of Health, 6011 Executive
Boulevard, Suite 325, Rockville, Maryland 20852-3804, Phone: (301) 435-
5019; Fax: (301) 402-0220; e-mail: shmilovm@mail.nih.gov. Information
about Patent Applications and pertinent information not yet publicly
described can be obtained under the terms of a Confidential Disclosure
Agreement.
Respondents interested in submitting a CRADA Proposal should be
aware that it may be necessary to secure a license to the above-
mentioned patent rights in order to commercialize products arising from
a CRADA.
[[Page 9831]]
Dated: February 19, 2004.
Dr. Carl Roth,
Associate Director for Scientific Program Operations, National Heart,
Lung, and Blood Institute.
[FR Doc. 04-4532 Filed 3-1-04; 8:45 am]
BILLING CODE 4140-01-M