Trach Sense

Emergencies involving tracheostomies, such as improper placement, obstruction, and accidental decannulation, pose critical risks, particularly in pediatric patients. These events can result in severe injury or death within minutes due to delayed detection. Current monitoring technologies, such as pulse oximeters, fail to provide real-time alerts for tracheostomy-specific complications.

About 20% of tracheostomized children experience an emergency like obstruction or decannulation, with a 4 to 6% mortality rate. Approximately 4,000 pediatric tracheostomies are performed annually in the U.S. and 25,000 globally, for durations that range from six months to a lifetime.

Accidental decannulation and airway obstruction are among the leading causes of tracheostomy-related complications in children, and either can cause permanent neurological damage or death if it is not caught within minutes. Despite that risk, no existing medical technology reliably detects these events in a tracheostomized child who is not ventilator-dependent, the group most likely to be mobile and unmonitored during the day.

To study the problem safely, we developed a pediatric tracheal breathing model system. Anatomically accurate airway models for three age groups (0 to 3 months, 2 to 4 years, and 10 to 12 years) were built with modeling software and a 3D printer, then paired with a breathing simulator that reproduces age-dependent respiration patterns. The model let us stage realistic tracheostomy emergencies and see exactly what a monitoring device would need to detect.

Published work behind this project: Equitable Care for Children With a Tracheostomy, “100 Things I Wish Someone Would Have Told Me”, and Tracheostomy Tube Monitoring Accessory to Detect Accidental Decannulation and Obstruction Emergencies. All three abstracts are here.

We engineered a custom carbon-dioxide monitoring attachment for the tracheostomy tube and used it to collect breathing-waveform data while staging the three emergency types on the model: improper insertion, accidental decannulation, and mucus obstruction, across all three age groups.

The CO2 waveforms told each emergency apart. During incorrect insertion, accidental decannulation, and complete blockage, exhaled carbon dioxide stayed flat at ambient levels; partial mucus obstruction lowered the waveform amplitude relative to normal breathing. These distinct signatures are the basis for the emergency-detection software now being built into the Trach Sense sensing accessory.

In 2024 and 2025 the Biodesign Program at Children’s National Hospital was awarded non-diluted funding for developing Trach Sense through the Children’s Hospital Founder’s Auxiliary Board and The Alliance for Pediatric Device Innovation (APDI). We have filed a patent, engaged early with the FDA through a PCI meeting, and have submitted our FDA Pre-Submission application. We have conducted our second phase of pre-clinical testing. Approved by the IRB in 2026, our clinical pilot study puts Trach Sense against the gold standard for detecting an airway event, a ventilator, at Children’s National Hospital. If you are interested in this technology please visit The CNH Innovation Ventures Licensing Office.

Design Team: Jules Sherman, MS, MFA, Kaylee Meyers, Ph.D., Ghee Ong, Ph.D., Habib G. Zalzal, MD, FACS, Ethan L Cooper, Arsalan Siddiqui, Noah Jagdman, Shahmeel Naseem, Tuan Ishaque Aqeel Muthaliff

Special thanks to the Fischell Institute for Biomedical Devices at the University of Maryland, College Park for developing and conducting the experiments.

Patent Pending: Tracheostomy Tube Complication Monitoring Accessory and Uses Thereof (2023-008-02, 63654838 filed 5/31/2024; 19/223,580 filed 5/30/2025)