The objective of the Phase 1 grant is to design, develop, and demonstrate feasibility of TrachAlarm, a novel, low-cost accessory to automatically detect and alert caregivers when a tracheostomy tube has become accidentally removed from the patient.. Tracheostomy provides a critical, life-supporting function for over 6.5 million individuals in the United States with over 100,000 new procedures performed each year. Each one of the patients would benefit from the TrachAlarm. Some tracheostomies are temporary while others are permanent. The tracheotomy procedures are done on patients ranging from birth to the elderly. Many of the patients are not attached to ventilators and rely on the caregiver to physically monitor and observe the position of the tracheostomy at all times. Patients living with tracheostomy tubes live with the life-threatening danger of accidental decannulation. When this event occurs, it is an emergency and requires immediate recognition and reinsertion of the tracheostomy tube due to the rapid closure of the tracheotomy opening. The tracheotomy opening begins to become smaller within moments after the tracheostomy tube is out. If the event is recognized immediately, it may be possible to reinsert the tracheostomy. If the closure of the tracheotomy has begun and the size of the opening decreases, the caregiver can attempt to insert smaller sizes of the tracheostomy tube. If the tracheostomy tube is not reinserted in a timely manner, the patient is at risk for complications such as hypoxia, respiratory failure, pneumothorax, subcutaneous emphysema, pseudotract formation, stomal stenosis, tracheoinnominate fistula, sternoclavicular osteomyelitis, cardiac arrest, and ultimately death. In essence, immediate recognition and reinsertion of a tracheostomy tube which is removed from its desired position, is extremely important to sustain life and prevent irreversible damage. Accidental decannulation is the number one early complication of tracheostomies and is the cause of morbidity and mortality in hospitals, extended care facilities, and at home. Patients with tracheostomies that have been left unattended, even briefly, have been found dead with their tracheostomy tubes nearby. The TrachAlarm will significantly decrease the number of accidental decannulations, and ultimately death or irreversible damage, by alerting the caregiver of the movement of the tracheostomy tube from its desired position and affording the caregiver the opportunity to reinsert the tracheostomy tube in a timely manner; therefore, reestablishing the airway. The TrachAlarm will be used for all ages, fits multiple sizes and brands of tracheostomy tubes, and is cost effective. By preventing irreversible damage in patients living with tracheostomy tubes, the TrachAlarm will assist in preventing rising healthcare costs for ventilator dependent patients. Health care costs for ventilator dependent patients are expected to skyrocket by the year 2020.

Public Health Relevance

A solution to Accidental Decannulation/Tracheal Dislodgement, continues to be an unmet need for patients living with tracheostomies. Development of the Trach Alarm, which alerts the caregiver of movement of the tracheostomy from its desired position, or 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.

National Institute of Health (NIH)
National Institute of Nursing Research (NINR)
Small Business Innovation Research Grants (SBIR) - Phase I (R43)
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Special Emphasis Panel (ZRG1)
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Diana, Augusto
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Innovations Unlimited, LLC
United States
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