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

The goal of this Administrative Supplement to Parent Grant R42AG059451 in response to responsive to PAS-17-065 is to allow mass production of a novel device to provide relief to critically ill patients affected by thesedation shortage resultant from the COVID-19 pandemic. Through access to plastic injection molding,assembly and logistics, Healthy Design will be able to realize an acceptable time frame to produce, makeavailable and support the use of its novel medical device. Healthy Design expects that streamlining productionwill minimize sedation usage while minimizing restraint, agitation, and delirium and increasing mobility withoutextra staff or other valuable resources.The COVID-19 pandemic has caused a ripple effect in our ICU supply chain, not the least of which is asedation shortage. We are conserving as much as possible by utilizing the less expensive and more abundantmedications from the benzodiazepine sedative category which were until now discouraged by published ICUguidelines; however, these supplies are also rapidly depleting. In the ICU setting, sedation is required forconfused patients with vital medical equipment, restrained intubated patients, patients with severe acute lungdisease resulting in ventilator dyssynchrony, and for those dyssynchronous patients who require a paralytic.While all of these categories of illness include COVID and non-COVID patients, in order to reserve sedation forthe most needy patients, we must reduce sedation for other patients. The Exersides™ Refraint™ was createdto safely reduce the need for sedation by reducing restraint and agitation. As immobility, agitation and sedationare known to lead to delirium and post-intensive care syndrome (PICS), there will likely be further benefits ofthe device. Thus far, Exersides™ has successfully completed a preliminary Pilot Study, a Phase I trial and,except for the COVID-related trial suspension, is currently in its multi-site Phase II trial as part of this STTRFast-Track award.Another phenomenon we are facing due to the current pandemic is an almost complete absence of familyvisitation. Together with an overstretched ICU staff, this loss is leading to patients spending more time alonewhile critically ill. Lack of availability to attend to each patient actually encourages increased sedation andrestraint in an attempt to keep everyone safe while caring for more patients. Exersides™ is intended to keepvital tubes and lines safe while allowing thoracic movement for pulmonary secretion clearance, gut functionand muscle tone preservation. Physicians are realizing they will be making difficult choices as to whether it ishumane to place a critically ill patient on a ventilator and strap them to the bed while awake. From our trials todate, we work with nurses and physicians who are familiar with Exersides™ and understand the concept of asafe, alone, awake, mobile intubated patient.The pathway to Healthy Design's ultimate goal of making the Exersides™ Refraint™ available to all hospitalsin time to address the concerns forced upon us by the sedation shortages is clear. Design Controls and aQuality Management System are in place and FDA registration is completed. Design files for translation from3D printing used to make prototypes to injection molding for mass production are in their final stages. HealthyDesign will partner with Progressive Plastics, Egli Machine Co. or Sinicon Plastics, depending on their bidswhich are currently under consideration. Manufacturing Solutions Inc and Kalow Technologies are bidding on acontract to assemble, package and ship the device. Preliminary quotes are listed in the Budget Justificationsection of this application. Vermont Manufacturing Extension Center is providing assistance to Healthy Designto foster its own workforce including receiving, assembly, and distribution. Healthy Design's management teamwill lead the efforts to liaise with hospital administrators and purchasing agents to provide a seamless processfor procurement of the novel device. Clinical educators will be available to provide remote training and supportto sites for onboarding of the Exersides™ Refraint™.