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 Alzheimers Disease and Related Dementias. Healthy Design is developing the novel ExersidesTM restraint that allows arm mobility but prohibits hands from reaching oral/nasal endotracheal and feeding tubes or intravenous lines. Because it permits mobility, ExersidesTM may reduce agitation and the need for sedatives. In preliminary pilot testing, ExersidesTM has demonstrated very encouraging results. The objectives of this STTR Fast-Track project are to optimize ExersidesTM 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 ExersidesTM 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 ExersidesTM 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 ExersidesTM 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 ExersidesTM 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 ExersidesTM 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.
Public Health Relevance Statement: PROJECT NARRATIVE To prevent self-removal of endotracheal and nasogastric tubes, and intravenous lines, older critically ill patients in the intensive care unit are often restrained with traditional wrist restraints. However, wrist restraints cause agitation, increased use of sedatives, prolonged immobility, and delirium, all of which can lead to long-term cognitive impairment similar to Alzheimers Disease and Related Dementias. Successful completion of this project will demonstrate that use of a novel restraint increases mobility; reduces agitation, use of sedating medications, and delirium; and exhibits high satisfaction and acceptability among patients, family and hospital staff. This 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.
Project Terms: actigraphy; Agitation; Alzheimer's Disease; Analgesics; Antipsychotic Agents; arm; base; Beds; Biomedical Engineering; Biometry; Care given by nurses; Caring; clinical care; Clinical Research; Cognition; Collaborations; Commerce; Critical Care; Critical Illness; Delirium; Dementia; design; Devices; Effectiveness; Elderly; endotracheal; Enrollment; Enteral Feeding; Equipment; Evaluation; Excision; Exhibits; experience; Family; Family member; Family Nursing; Feedback; Goals; Hand; high risk; Hospitals; Immobilization; Impaired cognition; improved; Incidence; Injury; innovation; Intensive Care Units; Intervention; Intravenous; Laceration; Lead; Measurement; Measures; Mechanics; modifiable risk; mortality; multidisciplinary; Muscle Weakness; Nose; novel; older patient; Oral; Outcome; Outcome Measure; Patient risk; Patients; Perception; Pharmaceutical Preparations; Phase; Physical Function; Positioning Attribute; Preparation; prevent; primary outcome; prospective; Prospective Studies; prototype; Qualitative Evaluations; Qualitative Research; Quantitative Evaluations; Randomized Controlled Trials; Recording of previous events; Research; Research Personnel; Resistance; response; restraint; Risk; Risk Factors; Safety; satisfaction; secondary outcome; Sedation procedure; sedative; Site; Skin; Small Business Technology Transfer Research; Specific qualifier value; Testing; Tube; Upper Extremity; Wrist
