Use of a Biophysical Device to Detect Pressure Ulcers in SCI

使用生物物理设备检测 SCI 中的压疮

• 批准号: 8857155
• 负责人: Marylou Guihan
• 金额: --
• 依托单位: EDWARD HINES JR VA HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-04-01 至 2013-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8857155
• 关键词: Address; Ambulatory Care Facilities; Anatomy; Area; Behavior; Behavioral; Buttocks; Caregivers; Caring; Cicatrix; Clinic Visits; Clinical Trials; Communities; Coupled; Data; Data Sources; Decubitus ulcer; Dermal; Development; Devices; Early Diagnosis; Early Intervention; Edema; Educational process of instructing; Elderly; Enrollment; Erythema; Esthesia; Future; Hand; Healed; Health; Health Care Costs; Healthcare; Healthcare Systems; Heel; High Prevalence; Home visitation; Hospitals; House Call; Individual; Inflammation; Inflammatory; Intervention; Intervention Studies; Interview; Left; Length of Stay; Light; Location; Measures; Medical; Medical Records; Methods; Minority; Nursing Homes; Outcome; Outpatients; Participant; Patients; Persons; Phase; Physiological; Pigments; Pilot Projects; Population; Prevention; Prevention program; Preventive; Preventive Intervention; Provider; Pus; Quality of life; Recurrence; Rehabilitation therapy; Relative (related person); Reporting; Research; Research Design; Research Methodology; Resolution; Risk; Risk Assessment; Sampling; Site; Skin; Skin Tissue; Skin Ulcer; Spinal cord injury; Spinal cord injury patients; Staging; Structure; Time; Tissues; Touch sensation; Trochanters; Variant; Veterans; Visual; Water; Woman; Work; base; cohort; community reintegration; cost; design; follow-up; healing; high risk; improved; ischium; meter; nutrition; patient home care; pressure; prevent; prospective; sacrum; screening; tool

DESCRIPTION (provided by applicant): 1. Purpose. Persons with spinal cord injury (SCI) are at high risk for pressure ulcers (PUs) throughout their lifetime due to decreased mobility and lack of sensation, coupled with other physiologic changes. The purpose of this study is to evaluate: a) the relationship between sub-epidermal moisture (SEM) (water content in skin and tissue), a measure of edema from inflammatory changes in the tissues, and non-visible pressure induced tissue damage (pre-stage I damage) and stage I PUs on the sacrum and buttocks in veterans with SCI, and b) address the strength of the relationship of SEM at various anatomic locations. The specific aims for this study are to: 1) describe the relationship of SEM to pressure induced tissue damage over sequential weeks in veterans with SCI, 2) assess the relative strength of SEM and visual skin assessment as indicators of PUs at various anatomic locations, and 3) explore variation in SEM values based on PU prevention and skin health care actions. 2. Background. A non-invasive, practical method of detecting early PrUs has not been evaluated in the SCI population. Data from elderly nursing home residents at risk of developing PrU and pilot work with veterans with SCI provides support for evaluating use of SEM measures in veterans with Increase in SEM predicted an increased presence of erythema/stage 1 PrU the next week. Feasibility pilot data on SEM were collected with veterans with SCI from the Long Beach (LBVA) and Hines SCI Centers and observed over 16 weeks using an alternative handheld dermal phase meter. Veterans were followed in the hospital and home care settings with VSA and SEM obtained from the sacrum, ischium, trochanters, buttocks, and heels. A total of 31 patients were enrolled (Hines=9; LBVA=22). Results show that SEM was higher at sites with erythema present, and sites with scar tissue showed lower SEM values. However, 16 weeks is insufficient time for development of erythema in this population. 3. Expected Outcomes/Products. This study addresses issues of prevention and early detection. The practical impact of this study will be to more fully evaluate SEM as a tool for detecting early PrUs in veterans with SCI to inform a larger study of a multi-component preventive intervention based on the detection of early skin damage using SEM. 4. Methods and Research Plan. a. Study design and approach. A prospective cohort, descriptive study is proposed to evaluate the relationship between SEM measured with a handheld device and VSA of stage 1 PUs weekly for 40 weeks in veterans with SCI. Participants will receive weekly VSAs and SEM measures, medical record review, brief structured interviews, and PrU risk assessment. b. Population and sample. 100 SCI patients (50 each at Hines and LBVA), who are receiving outpatient or follow-up care are eligible, including women and minorities. c. Definition of the problem. If SEM can better detect pressure induced skin damage at early stages even for veterans with differing risk levels, allowing for prompt prevention interventions, evidence will be powerful for evaluating SEM through a clinical trial. The long-term objective is to evaluate SEM as a screening tool as a first step in designing more potent early intervention strategies to prevent serious PUs in veterans with SCI. d. Sources of data. Weekly VSA and SEM measures of subjects' sacrum, right and left heels, trochanters, ischium, and buttocks will be done at home visits or outpatient clinic visits for 40 weeks with the MoistureMeter D dermal phase meter (a light skin touch with the device wand for 8 seconds). Research staff will interview participants about skin health related behaviors weekly (activity level, strategies for pressure relief, nutrition).

描述（由申请人提供）： 1.目的.脊髓损伤（SCI）患者由于活动能力下降和感觉缺失，加上其他生理变化，一生中患压疮（PU）的风险很高。本研究的目的是评价：a）表皮下水分（SEM）（皮肤和组织中的含水量）（组织中炎症变化引起的水肿的测量）与SCI退伍军人骶骨和臀部上的不可见压力诱导的组织损伤（I期前损伤）和I期PU之间的关系，以及B）解决不同解剖位置的SEM关系的强度。本研究的具体目的是：1）描述连续几周内SCI退伍军人中SEM与压力诱导的组织损伤的关系，2）评估SEM和视觉皮肤评估的相对强度，作为不同解剖位置PU的指标，3）探索基于PU预防和皮肤保健措施的SEM值变化。2.背景尚未在SCI人群中评估检测早期PrU的非侵入性实用方法。来自老年疗养院居民的数据有发展PrU的风险，并与SCI退伍军人进行了试点工作，为评估SEM措施在退伍军人中的使用提供了支持，SEM的增加预测了下周红斑/1期PrU的增加。从长滩（LBVA）和Hines SCI中心收集了关于SEM的可行性试验数据，并使用另一种手持式皮肤相位计观察了16周。退伍军人在医院和家庭护理机构进行了随访，从骶骨、坐骨、转子、臀部和脚跟获得VSA和SEM。共入组31例患者（Hines=9例; LBVA=22例）。结果显示，存在红斑的部位的SEM值较高，而存在瘢痕组织的部位的SEM值较低。然而，16周不足以在该人群中发展红斑。3.预期成果/产品。这项研究涉及预防和早期发现问题。本研究的实际影响将是更全面地评估SEM作为检测SCI退伍军人早期PrU的工具，以告知基于使用SEM检测早期皮肤损伤的多组分预防性干预的更大研究。4.方法和研究计划。a.研究设计和方法。一个前瞻性队列，描述性研究，旨在评估之间的关系SEM测量与手持设备和VSA的阶段1 PU每周40周的退伍军人SCI。参与者将接受每周一次的VSA和SEM测量，医疗记录审查，简短的结构化访谈和PrU风险评估。B.人口和样本。100名正在接受门诊或随访治疗的SCI患者（Hines和LBVA各50名）符合条件，包括女性和少数民族。C.问题的定义。如果SEM可以更好地检测早期阶段的压力引起的皮肤损伤，即使是具有不同风险水平的退伍军人，允许及时的预防干预，证据将是强大的通过临床试验评估SEM。长期目标是评估SEM作为筛选工具，作为设计更有效的早期干预策略以预防SCI退伍军人严重PU的第一步。D.数据来源。在40周的家庭访视或门诊访视中，使用MoistureMeter D皮肤相位计（用器械刀头轻轻触摸皮肤8秒），每周测量受试者骶骨、左右足跟、转子、坐骨和臀部的VSA和SEM。研究人员将每周就皮肤健康相关行为（活动水平、减压策略、营养）对参与者进行访谈。