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: 8868000
• 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/8868000
• 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)患者一生中由于活动能力下降和感觉障碍，再加上其他生理变化，都有患压疮(PU)的高风险。本研究的目的是评估：a)在患有脊髓损伤的退伍军人中，表皮下水分(SEM)(皮肤和组织中的水分含量)(衡量组织炎症变化引起的水肿量)与不可见的压力诱导的组织损伤(I期前损伤)和I期骶骨和臀部脓液之间的关系，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)描述患有脊髓损伤的退伍军人连续几周的扫描电子显微镜与压力诱导的组织损伤的关系；2)评估扫描电子显微镜和视觉皮肤评估作为不同解剖位置脓肿的指标的相对强度；3)探索基于PU预防和皮肤保健作用的SEM值的变化。2.背景。一种无创、实用的早期PRU检测方法尚未在脊髓损伤人群中进行评估。来自老年疗养院居民的数据和与患有脊髓损伤的退伍军人的试点工作的数据为评估退伍军人使用扫描电镜措施提供了支持，扫描电子显微镜预测下周红斑/第一期PRU的出现增加。扫描电子显微镜的可行性试验数据收集了来自长滩(LBVA)和海因斯SCI中心的患有SCI的退伍军人，并使用另一种手持真皮相位仪观察了16周。在医院和家庭护理环境中对退伍军人进行跟踪，从骶骨、坐骨、粗隆、臀部和脚后跟获取VSA和扫描电子显微镜。共纳入31例患者(Hines=9例，LBVA=22例)。结果显示，有红斑的部位扫描电子显微镜较高，而有疤痕组织的部位的扫描电子显微镜数值较低。然而，在这一人群中，16周的时间不足以形成红斑。3.预期结果/产品。这项研究解决了预防和早期发现的问题。这项研究的实际影响将是更全面地评估扫描电子显微镜作为检测脊髓损伤退伍军人早期PRU的工具，为更大规模的研究提供基于扫描电子显微镜检测早期皮肤损伤的多组分预防性干预。4.研究方法和研究计划。研究设计和研究方法。一项前瞻性队列描述性研究被提出，以评估手持设备测量的扫描电子显微镜与40周的退伍军人SCI患者每周1期脓液的VSA之间的关系。参与者将接受每周的VSA和扫描电子显微镜测量、病历审查、简短的结构化访谈和PrU风险评估。B.人口和样本。接受门诊或后续治疗的100名SCI患者(Hines和LBVA各50名)符合条件，包括妇女和少数族裔。C.问题的定义。如果扫描电子显微镜能够更好地在早期阶段发现压力引起的皮肤损伤，即使是对不同风险级别的退伍军人，允许及时的预防干预，证据将是通过临床试验评估扫描电子显微镜的有力证据。长期目标是评估扫描电子显微镜作为筛查工具，作为设计更有效的早期干预策略的第一步，以预防患有脊髓损伤的退伍军人发生严重脓液。D.数据来源。每周对受试者的骶骨、左右脚跟、粗隆、坐骨和臀部进行VSA和扫描电子显微镜测量，在40周的家访或门诊中使用湿度计D真皮相仪(用设备棒轻触皮肤8秒)。研究人员将每周就皮肤健康相关行为(活动水平、缓解压力的策略、营养)采访参与者。