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: 7861566
• 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/7861566
• 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 treatment; 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; Screening procedure; 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; 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). PUBLIC HEALTH RELEVANCE: Significance of Research Currently veterans with SCI and their caregivers are expected to act as if they are constantly at high risk of developing PUs. However, this sense of urgency to perform preventive actions (essentially behavioral regimes) is difficult to maintain consistently over time because the available information is not specific enough to motivate such frequent, repetitive and intrusive behaviors. It is likely that if we can improve the quality of the information, then it may be easier to motivate persons with SCI to respond to changes in SEMs because it provides more meaningful information (e.g., a specific location shows signs of PU development within the next week). If the findings from the preliminary study are duplicated in this study with veterans with SCI, future intervention studies would focus on use of SEMs to reduce health care costs and improve important outcomes among veterans with SCI.

描述（由申请人提供）： 1. 目的。由于活动能力下降、感觉缺失以及其他生理变化，脊髓损伤 (SCI) 患者一生中患压疮 (PU) 的风险很高。本研究的目的是评估：a) 表皮下水分 (SEM)（皮肤和组织中的水含量）（组织炎症变化引起的水肿的衡量标准）与不可见的压力引起的组织损伤（I 期前损伤）和 SCI 退伍军人骶骨和臀部的 I 期 PU 之间的关系，以及 b) 探讨 SEM 在不同解剖位置的关系强度。本研究的具体目的是：1) 描述 SCI 退伍军人连续几周内 SEM 与压力引起的组织损伤的关系，2) 评估 SEM 和视觉皮肤评估作为不同解剖位置 PU 指标的相对强度，3) 探索基于 PU 预防和皮肤保健措施的 SEM 值的变化。 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。来自有发生 PrU 风险的老年疗养院居民的数据以及与 SCI 退伍军人的试点工作为评估 SEM 措施在退伍军人中的使用提供了支持，SEM 的增加预测下周红斑/1 期 PrU 的出现会增加。 SEM 的可行性试点数据是从长滩 (LBVA) 和海因斯 SCI 中心的 SCI 退伍军人那里收集的，并使用替代手持式皮肤相位计观察了 16 周以上。通过从骶骨、坐骨、转子、臀部和脚后跟获取 VSA 和 SEM，对医院和家庭护理机构的退伍军人进行跟踪。共有 31 名患者入组（Hines=9；LBVA=22）。结果显示，存在红斑的部位 SEM 较高，而存在疤痕组织的部位 SEM 值较低。然而，16 周的时间不足以让该人群出现红斑。 3. 预期成果/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 SEM 作为检测 SCI 退伍军人早期 PrU 的工具，为基于使用 SEM 检测早期皮肤损伤的多成分预防干预的更大规模研究提供信息。 4. 方法和研究计划。一个。研究设计和方法。提出一项前瞻性队列描述性研究，以评估 SCI 退伍军人使用手持设备测量的 SEM 与每周 1 期 PU 的 VSA 之间的关系，持续 40 周。参与者将收到每周 VSA 和 SEM 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。正在接受门诊或后续护理的 100 名 SCI 患者（Hines 和 LBVA 各 50 名）符合资格，其中包括女性和少数族裔。 c.问题的定义。如果 SEM 能够在早期更好地检测压力引起的皮肤损伤，即使对于具有不同风险水平的退伍军人来说也是如此，从而能够及时采取预防干预措施，那么通过临床试验评估 SEM 的证据将是有力的。长期目标是评估 SEM 作为一种筛查工具，作为设计更有效的早期干预策略以预防 SCI 退伍军人出现严重 PU 的第一步。 d.数据来源。每周对受试者的骶骨、左右脚跟、转子、坐骨和臀部进行 VSA 和 SEM 测量，为期 40 周，使用 MoistureMeter D 真皮阶段计（用设备棒轻轻接触皮肤 8 秒）在家访或门诊进行。研究人员将每周采访参与者有关皮肤健康相关行为（活动水平、减压策略、营养）。 公共卫生相关性： 研究的意义 目前，患有 SCI 的退伍军人及其护理人员的表现就好像他们始终处于发生 PU 的高风险中一样。然而，随着时间的推移，这种执行预防措施（本质上是行为制度）的紧迫感很难持续保持，因为现有信息不够具体，不足以激发这种频繁、重复和侵入性的行为。如果我们能够提高信息质量，那么可能会更容易激励 SCI 患者对 SEM 的变化做出反应，因为它提供了更有意义的信息（例如，某个特定位置在下周内显示出 PU 发展的迹象）。如果初步研究的结果在本研究中对患有 SCI 的退伍军人进行重复，那么未来的干预研究将侧重于使用 SEM 来降低医疗保健成本并改善患有 SCI 退伍军人的重要结果。