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Notice

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

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AGENCY:

National Institutes of Health, Public Health Service, 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.

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.

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Dated: February 19, 2004.

Dr. Carl Roth,

Associate Director for Scientific Program Operations, National Heart, Lung, and Blood Institute.

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[FR Doc. 04-4532 Filed 3-1-04; 8:45 am]

BILLING CODE 4140-01-M