Healthy Design Ltd. Co. — Department of Health and Human Services STTR Phase I: NIA

Description

ABSTRACT The goal of this Fast Track STTR project is to optimize and test a novel arm restraint in older critically ill mechanically ventilated patients that increases mobilityreduces agitationuse of sedative medicationsand deliriumand exhibits high satisfaction and acceptability among hospital stafffamily membersand patientsOlder mechanically ventilated patients are often immobilized with wrist restraints to prevent self extubation and are sedated to reduce agitation caused by their restraints and endotracheal tubeThis sedation and immobility lead to complicationsincluding delirium and muscle weaknessthat are independently associated with longterm cognitive impairmentreduced physical functioningand mortalitySpecificallythe incidence and duration of delirium in the ICU are strongly and independently associated with long term cognitive impairment that is similar to Alzheimer s Disease and Related DementiasHealthy Design is developing the novel ExersidesTM restraint that allows arm mobility but prohibits hands from reaching oral nasal endotracheal and feeding tubes or intravenous linesBecause it permits mobilityExersidesTM may reduce agitation and the need for sedativesIn preliminary pilot testingExersidesTM has demonstrated very encouraging resultsThe objectives of this STTR Fast Track project are to optimize ExersidesTM and evaluate it in a randomized controlled trialRCTin older critically ill patients at high risk for delirium and associated long term cognitive impairmentThe multidisciplinary investigator team has expertise in critical careextensive experience in conducting ICU RCTsand a history of successful collaborationDuring Phase I Aimthe current ExersidesTM prototype will be revised based on prior feedback and tested inhealthy subjectsIn Phase I Aima prospective study will be performed inolder mechanically ventilated patients to demonstrate thatthe revised ExersidesTM prototype is safe andthe RCT proposed in Phase II is feasibleThe milestones to proceed to Phase II are to demonstrate thatthe revised ExersidesTM restraint has mean incidence rate andltacrosspre specified safety criteria in mechanically ventilated older patients who require restraintandthe RCT in phase II is feasible by successfully enrollingICU patients into Aimand completing at leastof all proposed outcome measuresIn Phase IIAima multi site within patient crossover RCT in older mechanically ventilated patients requiring restraint will be conducted to test the following outcomes in ExersidesTM versus traditional wrist restraintMobility assessed by actigraphyprimary outcomeAgitationdeliriumand medication usesecondary outcomesandSatisfaction with and acceptability perceptions of the devicesecondary outcomesSuccessful completion of this project will result in an ExersidesTM restraint that is ready for final optimzation in preparation for commercizationand is suitable for larger clinical studies to demonstrate effectiveness reducing long term cognitive impairment in older ICU patients PROJECT NARRATIVE To prevent self removal of endotracheal and nasogastric tubesand intravenous linesolder critically ill patients in the intensive care unit are often restrained with traditional wrist restraintsHoweverwrist restraints cause agitationincreased use of sedativesprolonged immobilityand deliriumall of which can lead to long term cognitive impairment similar to Alzheimer s Disease and Related DementiasSuccessful completion of this project will demonstrate that use of a novel restraint increases mobilityreduces agitationuse of sedating medicationsand deliriumand exhibits high satisfaction and acceptability among patientsfamily and hospital staffThis project has high potential to lead to a paradigm shift in the care of older critically ill patients by demonstrating that a novel restraint device reduces physical and cognitive impairment