Tracheostomy provides a critical, life-supporting function for over 6.5 million individuals in the U.S. with over 110,000 new procedures each year. The TrachAlarm is a novel, low-cost accessory to automatically detect and alert caregivers when a tracheostomy tube is accidentally removed from a patient. It provides a low-cost, accessible solution for tracheostomy patients and caregivers by utilizing magnetic sensing and smart alarms. The system integrates magnetic sensors in the patient dressing, and an alarm unit that easily connects to a tracheostomy flange and trach-tie. When the dressing is placed on the patient?s neck, magnetic sensors automatically align (around the periphery of the stoma) with the trachea insertion location. The alarm unit includes circuitry to detect the magnetic field. If the tube is moved away from the trachea, the alarm unit moves along with it, removing the detected magnetic field, creating an audible and visual alarm for the caregiver. Significant innovations distinguish the TrachAlarm from other market technologies. First, existing sensors and alarms are only available on ventilators that may be connected, but not for patients not requiring ventilators. Second, magnetic field technology provides a low-cost, low-burden device, easy for caregivers to use. These features will greatly improve technology accessibility to wide ranging demographics and socioeconomic disparate populations. Finally, accurate and automated alarms provide a significant benefit to patients by improving safety and preventing adverse events with overall burden to caregivers reduced. Phase II will expand upon successful Phase I prototype results to launch a commercially and clinically deployable TrachAlarm. The project is strategically positioned with four main objectives over a two-year period with specific tasks and success milestones.
Aim 1 will use Phase I results to optimize device components, system packaging and alarm delivery. This includes finalizing all electronic components, device form factor, and developing all system packaging, user guides, and labeling for shipping and use. This task will enhance device safety and effectiveness by extending the on-device alarm to wireless mobile alarming. All modifications and additions will be technically verified by formal test cases.
Aim 2 will target algorithmic enhancements to the alarming strategy to optimize both sensitivity and specificity. While the device requires 100% sensitivity, it is critical high specificity is also achieved to ensure users respond to the alarm when it occurs.
Aim 3 will transition all engineering designs to formal manufacturing and quality procedures. This will include scaling the design for large scale production, minimizing costs, supplier assessments, and assembly instructions. A pre-production run of devices using the full-scale manufacturing procedures will be tested as per all required input specifications, medical device standards, and quality regulations. Finally, Aim 4 will complete a final update to any device design or manufacturing procedures and produce first article devices. These devices will be implemented in a large- scale field usability study to determine performance, effectiveness, and safety in the target user population.
A solution to Accidental Decannulation/Tracheal Dislodgement, continues to be an unmet need for patients living with tracheostomy tubes. Development of the TrachAlarm?, which alerts the caregiver of movement of the tracheostomy tube from its desired position, or that it has completely dislodged, will allow the caregiver to immediately recognize the event and reinsert the tracheostomy tube in a timely manner and significantly decrease the number of deaths or irreversible damage resulting from same. More than 50,000 patients have suffered from either permanent damage or death resulting from accidental decannulation/tracheal dislodgement in hospitals, health care facilities, and at home.