Adaptation of an Adult Endotracheal Tube Monitoring System for Use in Neonatal In

Award Information
Agency: Department of Health and Human Services
Branch: N/A
Contract: 1R43HL106367-01
Agency Tracking Number: HL106367
Amount: $448,972.00
Phase: Phase I
Program: SBIR
Awards Year: 2010
Solicitation Year: 2010
Solicitation Topic Code: NHLBI
Solicitation Number: PHS2010-2
Small Business Information
SONARMED, INC.
SONARMED, INC., 5513 West 74th Street, Indianapolis, IN, -
DUNS: 198245628
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 JEFFREY MANSFIELD
 (317) 489-3161
 JMANSFIELD@SONARMED.COM
Business Contact
 JEFFREY MANSFIELD
Phone: (317) 489-3161
Email: jmansfield@sonarmed.com
Research Institution
N/A
Abstract
DESCRIPTION (provided by applicant): Endotracheal tube (ETT) intubation in neonates is associated with numerous complications which create immediate costs in excess of 250M annually in the U.S., as well as post-incidence costs that can be considerable, and immeasurable emotional costs to parents and clinicians. Compared to adults, this patient group is especially fragile where a slight movement of the ETT into an improper location can lead to rapid deterioration of their condition sometimes resulting in catastrophic consequences. SonarMed has developed a novel device using a sonar-based technique to provide precise, real-time adjunctive information regarding endotracheal tube position and function in the adult intensive care unit. While this technology, called the SonarMed Airway Monitoring System (AMS), will provide benefits in the adult ICU, the greatest impact from its use is expected to be experienced in the neonate, where it will offer clinicians the ability to noninvasively and continuously monitor tube placement without the use of x-rays. The long-term objective of this proposed project is to develop an AMS appropriate for use in neonates. To accomplish this, the first step will be to determine the feasibility of adapting the AMS for use in the NICU. This Phase I project will focus on first determining the unique NICU user requirements through surveys with NICU personnel, adapting the adult AMS for NICU-size ETTs, and collecting acoustic reflection data in both animals and humans. The acoustic reflection data will then be used to investigate signal optimization techniques and develop a prototype ETT position tracking algorithm. Following Phase I, the AMS will be re-engineered based on the requirements established by the end-users, evaluated in clinical studies to show safety and efficacy, and finally submitted to the FDA for market clearance. With over 43,000 NICU intubations per year in the U.S., the market for this product is expected to be in excess of 18MM per year. PUBLIC HEALTH RELEVANCE: There are currently a number of challenges with using breathing tubes in premature infants. The consequences of these challenges are significant in terms of both health outcomes for the infant as well as costs to the U.S. healthcare system. This research will provide caregivers with a new monitoring tool intended to reduce the frequency and severity of complications associated with breathing tube use in premature infants.

* information listed above is at the time of submission.

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