Dual Respiratory Effort and Airflow Monitor Belt using a new gel microphone
Department of Health and Human Services
Agency Tracking Number:
Solicitation Topic Code:
Small Business Information
CLEVELAND MEDICAL DEVICES, INC.
4415 EUCLID AVE, CLEVELAND, OH, -
Socially and Economically Disadvantaged:
AbstractDESCRIPTION (provided by applicant): The goal of the proposed project is to develop and validate a new device capable of recording the respiratory airflow without the need for a pressure cannula, thermal sensor or other sensor being attached to a patient'sface. This new device will address the problem of patients not tolerating or inadvertently removing the sensor from their face while they try to sleep. Even more problematic is that the pressure cannula may not be tolerated by children, infants, and the special needs population, or even worse, the pressure cannula can actually cause obstruction or increased resistance to their airway. This new sensor will enable the collection of airflow data without the addition of any wires, tubes or other sensors on theface. This program will continue the design and development of this new sensor. Although an initial prototype was constructed, many improvements will be applied based on the experiences and knowledge gained in the preliminary data collection. A new prototype will then be bench tested using respiratory simulators and realistic models to characterize and verify the new design. The new design will then be used in a small clinical trial to collect data from a set of infants while they sleep. These infants willbe dual monitored with both the new prototype sensor and the gold standard for monitoring airflow with a pneumotachograph. Forced apneas will be performed and recorded from all of the subjects. The resulting data set will then be used to further refine the algorithms and data processing to further improve the sensor output. The final configuration of the sensor and the resulting algorithms should prove to be invaluable to pediatric and special needs clinicians as well as researchers for less invasive monitoring of patient airflow. PUBLIC HEALTH RELEVANCE: The monitoring of respiratory airflow in pediatric and neonatal populations suffers from sensors that can be dislodged, are uncomfortable, and can cause increased airway resistance. This program will design, build and test a small wearable device that will monitor respiratory airflow without the need for a pressure cannula or any other sensors on the child's face. This new sensor will facilitate airflow monitoring for everyone, but the infant and neonatal population will have the most to gain from the new technology.
* information listed above is at the time of submission.