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Commercialization, Adoption, Licensing and Manufacture of Exersides Refraints

Exersides 的商业化、采用、许可和制造

基本信息

批准号：
10516414
负责人：
Marie Pavini
金额：
$ 193.08万
依托单位：
HEALTHY DESIGN, LTD. CO.
依托单位国家：
美国
项目类别：
财政年份：
2021
资助国家：
美国
起止时间：
2021-09-30 至 2024-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10516414
关键词：
Address Adoption Agitation Alzheimer&apos s Disease Alzheimer&apos s disease related dementia American Medical Association Amputation Anatomy Blood Vessels Breathing Caregivers Caring Cessation of life Chemicals Clinical Clinical Trials Code Cognitive Collaborations Communication Consult Consultations Contracts Counseling Critical Illness Delirium Dementia Development Device Designs Devices Distance Education Early Mobilizations Education Elderly Engineering Enteral Feeding Environment Equipment Excision Exhibits Family Nursing Family member Feedback Freedom Goals Growth Hospitals Human Immobilization Impaired cognition Incidence Industrialization Infrastructure Intensive Care Intensive Care Units International Intervention Intravenous Lead Legal Legal patent Licensing Market Research Mechanical ventilation Medical Medical Device Methods Modeling Movement Muscle Weakness Outcome Patients Pharmaceutical Preparations Phase Physical Function Physical Restraint Pilot Projects Positioning Attribute Prevention Process Production Readiness Research Resources Risk Risk Factors Sedation procedure Small Business Technology Transfer Research Source Specialist Syndrome System Testing Tube Wrist arm clinical practice commercialization cost effective decubitus ulcer design economic outcome endotracheal experience improved innovation modifiable risk mortality multi-site trial new technology novel pandemic disease phase 1 testing phase I trial prevent response restraint safe patient satisfaction sedative tool usability

项目摘要

ABSTRACT The goal of this NIA STTR Commercialization Readiness Pilot is to traverse the Valley of Death in the early Launch period of Healthy Design’s commercialization to market a novel arm restraint alternative in older critically ill mechanically ventilated or confused 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.6-15 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.12,15 Healthy Design has developed the novel Exersides™ Refraint™ that allows arm mobility while keeping the patient safe from entanglement in the vital tubes and lines attached to the patient.162-164 Because it permits mobility, Exersides™ may reduce agitation and the need for sedatives. In a Pilot Study and a Phase I testing, Exersides™ has demonstrated very encouraging results. The objectives of this CRP project are to create the infrastructure necessary to meet production requirements and sustain independent growth. Now in Phase II/Year II of its clinical trial, Healthy Design is preparing for imminent Launch. This project has high potential to lead to a paradigm shift in the care of older critically ill or confused patients by demonstrating that a novel restraint device reduces physical and cognitive impairment.

摘要