INNOVATIONS UNLIMITED LLC — Department of Health and Human Services SBIR Phase I: NINR

Description

ABSTRACT The objective of the Phasegrant is to designdevelopand demonstrate feasibility of TrachAlarma novellow cost accessory to automatically detect and alert caregivers when a tracheostomy tube has become accidentally removed from the patientTracheostomy provides a criticallife supporting function for overmillion individuals in the United States with overnew procedures performed each yearEach one of the patients would benefit from the TrachAlarmSome tracheostomies are temporary while others are permanentThe tracheotomy procedures are done on patients ranging from birth to the elderlyMany 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 timesPatients living with tracheostomy tubes live with the life threatening danger of accidental decannulationWhen this event occursit is an emergency and requires immediate recognition and reinsertion of the tracheostomy tube due to the rapid closure of the tracheotomy openingThe tracheotomy opening begins to become smaller within moments after the tracheostomy tube is outIf the event is recognized immediatelyit may be possible to reinsert the tracheostomyIf the closure of the tracheotomy has begun and the size of the opening decreasesthe caregiver can attempt to insert smaller sizes of the tracheostomy tubeIf the tracheostomy tube is not reinserted in a timely mannerthe patient is at risk for complications such as hypoxiarespiratory failurepneumothoraxsubcutaneous emphysemapseudotract formationstomal stenosistracheoinnominate fistulasternoclavicular osteomyelitiscardiac arrestand ultimately deathIn essenceimmediate recognition and reinsertion of a tracheostomy tube which is removed from its desired positionis extremely important to sustain life and prevent irreversible damageAccidental decannulation is the number one early complication of tracheostomies and is the cause of morbidity and mortality in hospitalsextended care facilitiesand at homePatients with tracheostomies that have been left unattendedeven brieflyhave been found dead with their tracheostomy tubes nearbyThe TrachAlarm will significantly decrease the number of accidental decannulationsand ultimately death or irreversible damageby 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 mannerthereforereestablishing the airwayThe TrachAlarm will be used for all agesfits multiple sizes and brands of tracheostomy tubesand is cost effectiveBy preventing irreversible damage in patients living with tracheostomy tubesthe TrachAlarm will assist in preventing rising healthcare costs for ventilator dependent patientsHealth care costs for ventilator dependent patients are expected to skyrocket by the yearProject Narrative A solution to Accidental Decannulation Tracheal Dislodgementcontinues to be an unmet need for patients living with tracheostomiesDevelopment of the Trach Alarmwhich alerts the caregiver of movement of the tracheostomy from its desired positionor has completely dislodgedwill 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 sameMore thanpatients have suffered from either permanent damage or death resulting from accidental decannulation tracheal dislodgement in hospitalshealth care facilitiesand at home