Wong Holly, Kaufman Jaime, Baylis Barry, Conly John M, Hogan David B, Stelfox Henry T, Southern Danielle A, Ghali William A, Ho Chester H
W21C Research and Innovation Centre, Cumming School of Medicine, GD01 Teaching Research & Wellness Building, University of Calgary, 3280 Hospital Drive, NW, Calgary, AB, T2N-4Z6, Canada.
Division of General Internal Medicine, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.
Trials. 2015 Sep 29;16:434. doi: 10.1186/s13063-015-0949-x.
Interface pressure is a key risk factor in the development of pressure ulcers. Visual feedback of continuous interface pressure between the body and support surface could inform clinicians on repositioning strategies and play a key role in an overall strategy for the prevention and management of pressure ulcers.
METHODS/DESIGN: A parallel two-group randomized controlled clinical trial will be conducted to study the effect of continuous pressure imaging on reducing interface pressure and on the incidence of pressure ulcers in vulnerable hospital patients. A total of 678 eligible consenting inpatients at risk of pressure ulcer development in a tertiary acute care institution will be randomly allocated to either having the ForeSite PT™ system with the liquid-crystal display monitor turned on to provide visual feedback to the clinicians while also collecting continuous interface pressure data (intervention group) or to having the ForeSite PT™ system with monitor turned off (that is, not providing visual feedback) but still collecting continuous interface pressure data (control group), in a ratio of 1:1. Continuous interface pressure data will be collected in both groups for 3 days (72 h). Data collection will continue until discharge for a subset of approximately 60 patients. The primary outcome will be the differences in the two groups' interface pressure analysis. Interface pressure readings will be collected through hourly samplings of continuous interface pressure recordings. Secondary outcomes will be the differences between the two groups in pressure-related skin and soft tissue changes in areas at risk of pressure ulcer (obtained at baseline within 24 h of admission) and on the third day of the trial or at discharge and perceptions of the intervention by patients and clinicians (obtained on the third day or at discharge).
This will be the first randomized controlled trial to investigate the effect of visual feedback with continuous interface pressure of vulnerable hospital patients across different care settings, and the association between interface pressure and development of pressure-related skin and soft tissue changes. The results could provide important information to guide clinical practice in the prevention and management of pressure ulcers.
ClinicalTrials.gov NCT02325388 (date of registration: 24 December 2014).
界面压力是压疮形成的关键风险因素。身体与支撑面之间持续界面压力的视觉反馈可为临床医生提供重新定位策略的信息，并在压疮预防和管理的整体策略中发挥关键作用。
方法/设计：将进行一项平行两组随机对照临床试验，以研究连续压力成像对降低界面压力及对易患压疮的住院患者压疮发生率的影响。在一家三级急性护理机构中，共有678名符合条件且同意参与的有发生压疮风险的住院患者将被随机分配，按1:1的比例，一组使用开启液晶显示器的ForeSite PT™系统，为临床医生提供视觉反馈，同时收集连续界面压力数据（干预组）；另一组使用关闭显示器的ForeSite PT™系统（即不提供视觉反馈），但仍收集连续界面压力数据（对照组）。两组均收集3天（72小时）的连续界面压力数据。对于约60名患者的子集，数据收集将持续至出院。主要结局将是两组界面压力分析的差异。界面压力读数将通过每小时对连续界面压力记录进行采样来收集。次要结局将是两组在压疮风险区域（入院后24小时内基线时获取）以及试验第三天或出院时与压力相关的皮肤和软组织变化的差异，以及患者和临床医生对干预的看法（在第三天或出院时获取）。
这将是第一项随机对照试验，旨在研究在不同护理环境下，为易患压疮的住院患者提供连续界面压力视觉反馈的效果，以及界面压力与压力相关皮肤和软组织变化发展之间的关联。研究结果可为指导压疮预防和管理的临床实践提供重要信息。
ClinicalTrials.gov NCT02325388（注册日期：2014年12月24日）。
