Disposable Respiratory Flow Measurement Device

Award Information
Agency: Department of Health and Human Services
Branch: N/A
Contract: 1R44HL091687-01A1
Agency Tracking Number: HL091687
Amount: $119,657.00
Phase: Phase I
Program: SBIR
Awards Year: 2008
Solitcitation Year: 2008
Solitcitation Topic Code: N/A
Solitcitation Number: PHS2007-2
Small Business Information
Duns: 007429504
Hubzone Owned: Y
Woman Owned: Y
Socially and Economically Disadvantaged: Y
Principal Investigator
 () -
Business Contact
Phone: (410) 385-0200
Email: jregan@keytechinc.com
Research Institution
DESCRIPTION (provided by applicant): The overall goal of this project is to develop, formally benchmark and validate a new flow sensor that will accurately quantify varying degrees of ventilation in pediatric and adult patient populations. The flow sensor is a simple, non-contact, disposable part that provides quantitative measurement of respiratory activity, even in the low-flow range. Current technologies lack the ability to accurately measure tidal volume but rather provide a semi-quantitative measure of respiratory patterns. A pneumotachograph (which can provide quantitative data) is too burdensome on patient comfort and breathing effort to obtain long term respiration measurements. Self-funded preliminary prototypes were developed prior to this grant su bmission and tested at the Johns Hopkins Sleep Disorders Center in Baltimore. The prototypes performed comparable to the gold standard (pneumotachograph). This project will finish development of the design, formally benchmark the flow sensor with the pneum otachograph, as well as examine the stability and accuracy of the design. Following this, the design will undergo planned improvements related to patient comfort and compliance. The project will conclude with formal clinical validation studies at overnight sleep clinics across a spectrum of patients to compare and validate the new flow sensor to current technology. Final design modifications will focus on optimization of a plug-and-play interface thereby simplifying integration with existing polysomnograp hic recording units and improving technician ease of use and patient comfort. The data and prototypes generated by this application will ultimately translate into improved care of patients that are susceptible to ventilatory failure and eventually as an am bulatory diagnostic system for patients in the home setting. This flow sensor will have an immediate impact on patient monitoring in sleep laboratories and will further influence diagnostic procedures in pulmonary medicine, anesthesia and other medical dis ciplines. PUBLIC HEALTH RELEVANCE: The proposed project will develop, formally benchmark and validate a new flow sensor that will allow the medical industry to accurately quantify ventilation. This flow sensor will measure a broad range of respiratory even ts, including subtle changes of breathing, in both pediatric and adult populations. Initially the flow sensor will be used as a diagnostic tool in the sleep lab environment, while future applications will include the flow sensor as a critical component of patient care in the hospital in-patient and ER as well as an ambulatory diagnostic tool for patients in the home setting.

* information listed above is at the time of submission.

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