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 mobility; reduces agitation, use of sedative medications, and delirium; and exhibits high satisfaction and acceptability among hospital staff, family members, and patients. Older 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 tube. This sedation and immobility lead to complications, including delirium and muscle weakness, that are independently associated with long- term cognitive impairment, reduced physical functioning, and mortality. Specifically, the 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 Dementias. Healthy Design is developing the novel Exersides? restraint that allows arm mobility but prohibits hands from reaching oral/nasal endotracheal and feeding tubes or intravenous lines. Because it permits mobility, Exersides? may reduce agitation and the need for sedatives. In preliminary pilot testing, Exersides? has demonstrated very encouraging results. The objectives of this STTR Fast-Track project are to optimize Exersides? and evaluate it in a randomized controlled trial (RCT) in older critically ill patients at high risk for delirium and associated long-term cognitive impairment. The multidisciplinary investigator team has expertise in critical care, extensive experience in conducting ICU RCTs, and a history of successful collaboration. During Phase I/Aim 1, the current Exersides? prototype will be revised based on prior feedback and tested in 3 healthy subjects. In Phase I/Aim 2, a prospective study will be performed in 8 older mechanically ventilated patients to demonstrate that 1) the revised Exersides? prototype is safe and 2) the RCT proposed in Phase II is feasible. The milestones to proceed to Phase II are to demonstrate that: 1) the revised Exersides? restraint has mean incidence rate <5% across 7 pre-specified safety criteria in mechanically ventilated older patients who require restraint; and 2) the RCT in phase II is feasible by successfully enrolling 8 ICU patients into Aim 2 and completing at least 90% of all proposed outcome measures. In Phase II, Aim 3 a multi-site within-patient crossover RCT in older mechanically ventilated patients requiring restraint will be conducted to test the following outcomes in Exersides? versus traditional wrist restraint: 1) Mobility assessed by actigraphy (primary outcome); 2) Agitation, delirium, and medication use (secondary outcomes); and 3) Satisfaction with and acceptability/perceptions of the device (secondary outcomes). Successful completion of this project will result in an Exersides? restraint that is ready for final optimzation in preparation for commercization, and is suitable for larger clinical studies to demonstrate effectiveness reducing long-term cognitive impairment in older ICU patients.
