Endotracheal Tube Monitor for Neonates

Award Information
Agency:
Department of Health and Human Services
Branch
n/a
Amount:
$446,711.00
Award Year:
2010
Program:
SBIR
Phase:
Phase I
Contract:
1R43HL105264-01
Award Id:
96385
Agency Tracking Number:
HL105264
Solicitation Year:
n/a
Solicitation Topic Code:
NHLBI
Solicitation Number:
n/a
Small Business Information
ARTANN LABORATORIES, INC., 1459 LOWER FERRY RD, TRENTON, NJ, -
Hubzone Owned:
N
Minority Owned:
N
Woman Owned:
N
Duns:
959147026
Principal Investigator:
ARMEN SARVAZYAN
(609) 333-0710
ARMEN@ARTANNLABS.COM
Business Contact:
NOUNE SARVAXYAN
() -
artann@artannlabs.com
Research Institute:
n/a
Abstract
DESCRIPTION (provided by applicant): Each year, at least 10,000 critically sick babies in respiratory failure are intubated for ventilator support. For these babies, intubation bears major health risks such as airway emergencies, cardiopulmonary arrest, pn eumothoraces. Neonates, however young, can be quite active, leading to undesirable tube movement and unplanned extubations. To date, there exists no reliable way of assessing Endotracheal Tube (ETT) position in real time without excessive X-ray radiation d oses. Episodic assessment by X-rays of the baby's head and neck used to determine tube position would not detect a mal positioned tube in real time. In fact, such assessments are often performed late, in response to bedside alarms that continuous monitor f or oxygen desaturations or poor ventilation. At this point, the effects of tube mal-position have already had detrimental effects on lung recruitment and gas exchange. An easy-to-use real-time sensor that indicates whether an endotracheal tube has moved ou t of 'good position' is needed. We propose to develop a device entitled Endotracheal Tube Monitor (ETM) that can detect the changes in the ETT position and help the nurse to reposition the tube. Artann Laboratories developed a proof-of-principle optical sy stem that can track the motion of a tube accurately and remotely through layers of tissue. The system was successfully tested in laboratory studies and in an in vivo animal model. In the proposed project, the ETM technology will be further tested and refin ed. The objectives of the study include: design, assemble and validate ETM alpha-prototype; conduct cadaver studies on sensitivity of ETM to the motion of the ETT; and design ETM beta-prototype based on the feedback from the laboratory and cadaver studies. The deliverables at the end of the two year study are ETM's bench validated performances, report on ease-of-use, accuracy of measurement, and individual and operator-to- operator variations, and detailed design and documentation for building the ETM beta- prototype for Phase II clinical studies. The main ETM market opportunity is in an increased safety of neonate mechanical ventilator support and a substantial cost reduction to an existing method of ETT monitoring. PUBLIC HEALTH RELEVANCE: Each year , at least 10,000 critically sick babies in respiratory failure are intubated for ventilator support. For these babies, intubation bears major health risks such as airway emergencies, cardiopulmonary arrest and pneumothoraces, To date, there exists no reli able and easy way of assessing endotracheal tube position in real time without chest radiology. The Endotracheal Tube Monitor (ETM), a compact, inexpensive and easy-to- use optical device proposed in this application will allow endotracheal tube position m onitoring without the use of hazardous X-ray radiation.

* information listed above is at the time of submission.

Agency Micro-sites


SBA logo

Department of Agriculture logo

Department of Commerce logo

Department of Defense logo

Department of Education logo

Department of Energy logo

Department of Health and Human Services logo

Department of Homeland Security logo

Department of Transportation logo

Enviromental Protection Agency logo

National Aeronautics and Space Administration logo

National Science Foundation logo
US Flag An Official Website of the United States Government