Endotracheal Tube Monitor for Neonates
Department of Health and Human Services
Agency Tracking Number:
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Small Business Information
ARTANN LABORATORIES, INC.
ARTANN LABORATORIES, INC., 1459 LOWER FERRY RD, TRENTON, NJ, -
Socially and Economically Disadvantaged:
AbstractDESCRIPTION (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, pneumothoraces. 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 doses. 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 for 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 out 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 system 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 refined. 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 reliable 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 monitoring without the use of hazardous X-ray radiation.
* information listed above is at the time of submission.