Turnova: The Clinical Efficacy, Manpower Reduction, and Cost-Effectiveness of Turn-Assist Alternating Pressure Air Mattresses for Pressure Injury Prevention in the ICU
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 236
- 试验地点
- 1
- 主要终点
- Time spent on turning and positioning
研究概览
简要总结
Pressure injuries are common in intensive care unit (ICU) patients who cannot reposition themselves. International guidelines recommend using support surfaces to redistribute pressure and regular turning to prevent these injuries. In Taiwan, high-specification foam mattresses (HSFM) with manual turning remain the standard, but frequent repositioning is labor-intensive and challenging in settings with limited nursing staff. The Turn-Assist Alternating Pressure Air Mattress (TAPAM) integrates pressure redistribution with automated lateral turning, potentially reducing nursing workload while maintaining preventive effectiveness. This study will compare TAPAM with HSFM plus manual turning in ICU patients, evaluating manpower requirements, time spent, perceived effort, and clinical outcomes. A cost-effectiveness and cost-benefit analysis will be conducted to assess the overall value of TAPAM for pressure injury prevention in high-risk ICU populations.
详细描述
This prospective comparative study will be conducted in the ICUs of a tertiary medical center in Taiwan. Adult patients at high risk for pressure injury and requiring assistance for repositioning will be enrolled and assigned to one of two interventions: (1) TAPAM, providing alternating pressure relief and programmed lateral turning, or (2) HSFM with manual repositioning according to standard ICU protocol.
Primary outcomes include manpower feasibility (number of staff required, time per turning) and clinical effectiveness (incidence of new pressure injuries). Secondary outcomes include economic indicators such as equipment costs, labor cost savings, and overall cost-effectiveness.
Economic evaluation will be performed from the hospital perspective, incorporating both direct costs (equipment, supplies, labor) and indirect savings from prevented injuries. Results will provide real-world evidence on whether TAPAM can improve care efficiency, reduce staff workload, and deliver cost-effective pressure injury prevention in high-dependency ICU settings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
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
- •Adult patients (≥18 years old) admitted to medical or surgical intensive care units (ICUs).
- •Admission time between 08:00 and 23:
- •Clinical condition requires ICU-level care.
排除标准
- •Repeat ICU admission during the study period.
- •Unstable spinal fracture.
- •Receiving cervical or skeletal traction.
- •Body weight >180 kg (exceeds mattress weight limit).
- •Declines participation in the study.
结局指标
主要结局
Time spent on turning and positioning
时间窗: Through ICU stay, up to 30 days (average per patient).
Duration (in minutes) from start to completion of each turning episode.
Perceived exertion of turning task
时间窗: Through ICU stay, up to 30 days (average per patient).
Nurses' subjective rating of physical effort required for each turning episode, measured using the Perceived Exertion Scale (PES);The scale ranges from 1 (no exertion at all) to 10 (maximal exertion). Higher scores indicate greater perceived exertion (worse outcome).
Manpower requirements for turning and positioning
时间窗: Through ICU stay, up to 30 days (average per patient).
Number of staff members required for each turning episode.
Time spent on turning and positioning
时间窗: Through ICU stay, up to 30 days (average per patient).
Duration (in minutes) from start to completion of each turning episode.
Perceived exertion of turning task
时间窗: Through ICU stay, up to 30 days (average per patient).
Nurses' subjective rating of physical effort required for each turning episode, measured using the Perceived Exertion Scale (PES);The scale ranges from 1 (no exertion at all) to 10 (maximal exertion). Higher scores indicate greater perceived exertion (worse outcome).
次要结局
- Incidence of new pressure injuries(From ICU admission through ICU discharge (up to 30 days).)
- Pressure injury incidence density(From ICU admission through ICU discharge (up to 30 days).)
- Pressure injury deterioration rate(From ICU admission through ICU discharge (up to 30 days).)
- Pressure injury deterioration density(From ICU admission through ICU discharge (up to 30 days).)
- Economic evaluation: Total care costs(Through study completion, up to 30 days after ICU discharge.)
- Pressure injury-free days(From ICU admission through ICU discharge (up to 30 days).)
- Economic evaluation:Labor costs(From ICU admission through ICU discharge (up to 30 days).)
- Economic evaluation:Equipment costs(Through study completion, up to 30 days after ICU discharge.)
- Economic evaluation: Cost-effectiveness ratio(Through study completion, up to 30 days after ICU discharge.)
- Economic evaluation : Cost-benefit ratio(Through study completion, up to 30 days after ICU discharge)