An RCT on Support Surfaces for Pressure Ulcer Prevention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 457
- 试验地点
- 2
- 主要终点
- Pressure Injury
研究概览
简要总结
Pressure injuries are a serious health care problem and affect millions of people. Most pressure injuries are avoidable with the application of best practices and with the use of appropriate technology. Support surfaces are a crucial component of any comprehensive prevention strategy. Decades of research have produced moderate and low levels of evidence upon which to base clinical decisions concerning how and when to apply support surfaces for prevention. This knowledge has been periodically assessed and assembled into clinical practice guidelines. There is good evidence that the combined group of active and reactive support surfaces is effective in preventing pressure injuries and that high-specification reactive foam surfaces are effective in preventing pressure injuries. But there is insufficient evidence that low air loss surfaces are more or less effective than other types of surfaces. Yet, low air loss surfaces are used for more than 17% of patients in acute care at high risk of developing pressure injuries.
The study is designed to determine if and when low air loss is effective in preventing pressure injuries, and what level of heat and moisture control performance is necessary for prevention effectiveness. The primary aim of the project is to compare the effectiveness of reactive support surfaces with low air loss to reactive support surfaces without low air loss in preventing pressure injuries for people with moisture risk factors in acute care. Support surfaces are currently marketed and identified by practitioners based on device features (e.g., low air loss, air fluidization, alternating pressure), categories (powered, non-powered, reactive, and active) and components (e.g., foam, gel, fluid).
The critical performance characteristics of low air loss systems are moisture, humidity and temperature management. Preliminary work has revealed that these characteristics vary widely among different low air loss products. A secondary aim of the proposed study is to explore associations between support surface performance characteristics and pressure injury outcomes to identify which low air loss performance characteristics and what level of those performance characteristics are necessary for the technology to be effective.
Successful completion of this project will fill a critical gap in evidence regarding the effectiveness of support surfaces with low air loss, and could influence a shift in the way support surfaces are characterized away from the current feature-based paradigm toward a more clinically relevant and generalizable performance-based paradigm.
详细描述
Pressure injuries are a serious health care problem and threaten the health and well-being of millions of people. Most pressure injuries are avoidable with the application of standard practices and proper utilization of existing technology. Support surface technology has been shown to prevent pressure injuries, but the effectiveness of specific features designed for management of tissue loads, microclimate (i.e., heat and moisture), and/or other therapeutic functions are unknown. Preclinical research has demonstrated that heat and moisture are important pressure injury risk factors. Low air loss is a support surface feature designed to manage the heat and moisture at the interface between the person and the surface. It is a feature that is invariably combined with the provision of pressure redistribution through immersion and envelopment. Clinical research has produced evidence to support the use of reactive support surfaces with good immersion and envelopment characteristics, but there is a gap in evidence regarding the effectiveness of microclimate management features.
This study aims to first determine if low air loss is effective for preventing pressure injuries. Second, to facilitate translation of the results to clinical practice, the study is designed to identify which low air loss performance characteristics and what levels of those performance characteristics are necessary for the technology to be effective.
Aim 1 will compare the effectiveness of reactive support surfaces with low air loss to reactive support surfaces without low air loss in preventing pressure injuries for people with moisture risk factors in acute care. This aim will also investigate the comparative effectiveness in subgroups defined by age, body mass index (BMI), Braden score, and Braden mobility subscale score. We will also investigate the association between pressure injury severity and treatment group.
Aim 2 will explore associations between support surface performance characteristics and pressure injury outcomes. Performance will be quantified by the microclimate control measures of evaporative capacity and heat flux.
An individual randomized design with 816 subjects will be used to achieve the aims. Participants will be randomized into either a low air loss or no-low air loss surface type across seven possible groups differentiated only by the support surface assignment. The seven surfaces will have a range of heat and moisture control performance characteristics. Biological variables, pressure injury incidence, pressure injury risk factors and related clinical conditions and procedures will be recorded and analyzed. For Aim 2, to explore associations between support surface performance characteristics and pressure injuries, we will determine threshold and cutoff values for optimum effectiveness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •total Braden Score <= 18
- •Braden Moisture sub-scale score 1 or 2
- •projected length of stay in hospital >= 4 days
- •absent of pressure injuries
排除标准
- 未提供
研究组 & 干预措施
Reactive, non-low air loss
Participants in this arm will use a reactive support surface without a low air loss feature
干预措施: Non-LAL (Device)
Reactive, Low air loss support surface
Participants in this arm will use a reactive support surface with a low air loss feature
干预措施: LAL (Device)
结局指标
主要结局
Pressure Injury
时间窗: Through study completion, an average of 7 days
Number of participants who had a new pressure injury occur during study participation
次要结局
未报告次要终点
研究者
David Brienza
Professor
University of Pittsburgh