Novel Arm Restraint For Critically Ill Patients To Reduce Immobility, Sedation, Agitation and Cognitive Impairment

NIH RePORTER · NIH · R42 · $374,498 · view on reporter.nih.gov ↗

Abstract

Novel Arm Restraint for Critically Ill Patients To Reduce Immobility, Sedation, Agitation and Cognitive Impairment Older, mechanically ventilated patients are often immobilized with wrist restraints to prevent self-extubation, and 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, as well as 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. The COVID-19 pandemic has caused a ripple effect in our ICU supply chain, not the least of which is a sedation shortage. In the US, widespread efforts to conserve include utilizing less expensive, more abundant medications from the benzodiazepine sedative category, which are discouraged by published ICU guidelines because of their well-documented detrimental effects on patients’ cognitive status. The goal of this Administrative Supplement to Parent Grant R42AG059451 is to allow mass production of Exersides™ to provide relief to critically ill patients affected by the sedation shortage resultant from the COVID-19 pandemic. As immobility, agitation and sedation are known to lead to delirium and post-intensive care syndrome (PICS), there will likely be further benefits of the device. Another impact of the COVID-19 pandemic is an almost complete absence of family visitation, and together with an overstretched ICU staff, this loss is leading to patients spending more time alone while critically ill. Exersides™ is intended to keep vital tubes and lines safe while allowing thoracic movement for pulmonary secretion clearance, gut function and muscle tone preservation. Healthy Design will be able to realize an acceptable time frame to produce, make available and support the use of Exersides™. Streamlined production of Exersides™ will help minimize sedation and also minimize restraint, agitation, and delirium, and increase mobility without extra staff or other resources. The pathway to Healthy Design’s ultimate goal of making the Exersides™ Refraint™ available to all hospitals in time to address the concerns forced upon us by the sedation shortages is clear.

Key facts

NIH application ID
10140229
Project number
3R42AG059451-02S1
Recipient
HEALTHY DESIGN, LTD. CO.
Principal Investigator
Dale Murray Needham
Activity code
R42
Funding institute
NIH
Fiscal year
2020
Award amount
$374,498
Award type
3
Project period
2018-04-01 → 2021-06-30