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 the sedation 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, make available and support the use of its novel medical device. Healthy Design expects that streamlining production will minimize sedation usage while minimizing restraint, agitation, and delirium and increasing mobility without extra 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 a sedation shortage. We are conserving as much as possible by utilizing the less expensive and more abundant medications from the benzodiazepine sedative category which were until now discouraged by published ICU guidelines; however, these supplies are also rapidly depleting. In the ICU setting, sedation is required for confused patients with vital medical equipment, restrained intubated patients, patients with severe acute lung disease 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 for the most needy patients, we must reduce sedation for other patients. The Exersides? Refraint? was created to safely reduce the need for sedation by reducing restraint and agitation. 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. 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 STTR Fast-Track award. Another phenomenon we are facing due to the current pandemic is an almost complete absence of family visitation. Together with an overstretched ICU staff, this loss is leading to patients spending more time alone while critically ill. Lack of availability to attend to each patient actually encourages increased sedation and restraint in an attempt to keep everyone safe while caring for more patients. Exersides? is intended to keep vital tubes and lines safe while allowing thoracic movement for pulmonary secretion clearance, gut function and muscle tone preservation. Physicians are realizing they will be making difficult choices as to whether it is humane to place a critically ill patient on a ventilator and strap them to the bed while awake. From our trials to date, we work with nurses and physicians who are familiar with Exersides? and understand the concept of a safe, alone, awake, mobile intubated patient. 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. Design Controls and a Quality Management System are in place and FDA registration is completed. Design files for translation from 3D printing used to make prototypes to injection molding for mass production are in their final stages. Healthy Design will partner with Progressive Plastics, Egli Machine Co. or Sinicon Plastics, depending on their bids which are currently under consideration. Manufacturing Solutions Inc and Kalow Technologies are bidding on a contract to assemble, package and ship the device. Preliminary quotes are listed in the Budget Justification section of this application. Vermont Manufacturing Extension Center is providing assistance to Healthy Design to foster its own workforce including receiving, assembly, and distribution. Healthy Design?s management team will lead the efforts to liaise with hospital administrators and purchasing agents to provide a seamless process for procurement of the novel device. Clinical educators will be available to provide remote training and support to sites for onboarding of the Exersides? Refraint?.
Sedation is provided to patients who are restrained and intubated due to critical illness to ameliorate the agitation from forced immobilization and inability to communicate while critically ill. Sedation is also given to non- intubated confused patients to reduce the likelihood of self-removal of vital medical equipment The sedation shortage due to the COVID-19 pandemic has resulted in the increased use of more abundant, more harmful forms of sedation which are themselves in short supply. The effects of this viral illness preferentially affect the elderly who are also at increased risk of critical illness in general. Successful completion of this project will result in timely access to a novel device to reduce sedation needs and usage through restraint and agitation reduction.
