Koronis Biomedical Technologies Corporation (KBT) proposes to develop an innovative point of care tracheostomy airflow monitoring system with alarm, targeting pediatric patients. Tracheostomy tube placement is an increasingly common pediatric practice in the United States. While this is a lifesaving procedure, it adds significant cost to our healthcare system and continues to be fraught with complications. Two serious risks of tracheostomy are dislodgement and mucous plugging of the tracheostomy tube. These can occur at any time while the child has the device in place. Small children are at particular risk of hypoxia, and are unable to clear their tubes, or communicate distress to caregivers. At present, there are no sufficient technologies to monitor for these events prior to patient hypoxia and deterioration when a child with a tracheostomy tube is not using a mechanical ventilator with its associated monitors and alarms. This condition affects children who are mechanically ventilated only part of the time, receive breathing assistance by CPAP or BiPAP, or are breathing spontaneously. This proposal device will adapt to the standardized end of a tracheostomy tube and will provide early warning to alert caregivers to an obstruction or dislodgement of the tube. The goal of this device is to trigger earlier caregiver intervention to prevent hypoxia related injury to the pediatric patient.
Recent advances in sensor technology enable the development of a tracheostomy tube attachment with integrated flow metering and alarm systems. The introduction of ultrasonic flow metering allows the creation of a precision system that monitors the true airflow at the tracheostomy tube whether the patient is assisted by mechanical ventilation or not. This innovative device will address the unmet need for a reliable monitoring solution that provides early warning of obstruction or decannulation during spontaneous or assisted breathing. (End of Abstract)
