Abstract
BACKGROUND: Pressure ulcers are insidious complications that affect approximately 2.5 million patients and account for approximately US$11 billion in annual health care spending each year. To date we are unaware of any study that has used a wearable patient sensor to quantify patient movement and positioning in an effort to assess whether adherence to optimal patient turning results in a reduction in pressure ulcer occurrence. METHODS/DESIGN: This study is a single-site, open-label, two-arm, randomized controlled trial that will enroll 1812 patients from two intensive care units. All subjects will be randomly assigned, with the aid of a computer-generated schedule, to either a standard care group (control) or an optimal pressure ulcer-preventative care group (treatment). Optimal pressure ulcer prevention is defined as regular turning every 2 h with at least 15 min of tissue decompression. All subjects will receive a wearable patient sensor (Leaf Healthcare, Inc., Pleasanton, CA, USA) that will detect patient movement and positioning. This information is relayed through a proprietary mesh network to a central server for display on a user-interface to assist with nursing care. This information is used to guide preventative care practices for those within the treatment group. Patients will be monitored throughout their admission in the intensive care unit. DISCUSSION: We plan to conduct a randomized control trial, which to our knowledge is the first of its kind to use a wearable patient sensor to quantify and establish optimal preventative care practices, in an attempt to determine whether this is effective in reducing hospital-acquired pressure ulcers. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02533726 .