Without proper monitoring, patients with artificial airways in the trachea are at high risk for complications or death. Despite routine maintenance of the tube, dislodged or copious mucus can obstruct the airway. Young children (≤3yrs) have difficulty tending to their own tubes and are particularly vulnerable to blockages. They require external respiratory sensors. In a hospital environment, ventilators, end-tidal CO_2 monitors, thermistors, and other auxiliary equipment provide sufficient monitoring of respiration. However, outpatient monitoring methods, such as thoracic impedance and pulse oximetry, are indirect and prone to false positives. Desensitization of caregivers to frequent false alarms has been cited in medical literature as a contributing factor in cases of child death. Ultrasonic time-of-flight (TOF) is a technique used in specialized industrial applications to non-invasively measure liquid and gas flow. Two transducers are oriented at a diagonal across a flow channel. Velocity measurement is accomplished by detecting slight variations in transit time of contra-propagating acoustic signals with a directional component parallel to air flow. Due to the symmetry of acoustic pathway between sensors, velocity measurements are immune to partial fouling in the tube from mucus, saliva, and condensation. A first generation proof of concept prototype was constructed to evaluate the ultrasonic TOF technique for medical tracheostomy monitoring. After successful performance, a second generation prototype was designed with a smaller form factor and more advanced electronics. This prototype was tested and found to measure inspired volume with a root-mean-square error < 2% during initial trials.
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