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 submission 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 pneumotachograph, 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 polysomnographic 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 ambulatory 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 disciplines.

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 events, 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. ? ? ?

Agency
National Institute of Health (NIH)
Institute
National Heart, Lung, and Blood Institute (NHLBI)
Type
Small Business Innovation Research Grants (SBIR) - Phase II (R44)
Project #
1R44HL091687-01A1
Application #
7539571
Study Section
Special Emphasis Panel (ZRG1-RES-E (10))
Program Officer
Rothgeb, Ann E
Project Start
2008-09-15
Project End
2009-03-14
Budget Start
2008-09-15
Budget End
2009-03-14
Support Year
1
Fiscal Year
2008
Total Cost
$119,657
Indirect Cost
Name
Key Technologies, Inc.
Department
Type
DUNS #
007429504
City
Baltimore
State
MD
Country
United States
Zip Code
21230
Kirkness, J P; McGinley, B M; Sgambati, F P et al. (2011) Developing quantitative physiological phenotypes of sleep apnea for epidemiological studies. Conf Proc IEEE Eng Med Biol Soc 2011:8319-22
Kirkness, J P; Verma, M; McGinley, B M et al. (2011) Pitot-tube flowmeter for quantification of airflow during sleep. Physiol Meas 32:223-37