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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
236
Device: Turn-Assist Alternating Pressure Air Mattress (TAPAM) Automated lateral turning with pressure redistribution.
Device: High-Specification Foam Mattress (HSFM) Standard ICU care support surface.
Nurse-performed scheduled manual turning (target every 2 hours, with pillows).
Supplemental pillows used to support and maintain patient position.
National Taiwan University Hospital
Taipei, Taiwan
Manpower requirements for turning and positioning
Number of staff members required for each turning episode.
Time frame: Through ICU stay, up to 30 days (average per patient).
Time spent on turning and positioning
Duration (in minutes) from start to completion of each turning episode.
Time frame: Through ICU stay, up to 30 days (average per patient).
Perceived exertion of turning task
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).
Time frame: Through ICU stay, up to 30 days (average per patient).
Incidence of new pressure injuries
Proportion of patients developing a new pressure injury (Stage 1-4) during ICU stay.
Time frame: From ICU admission through ICU discharge (up to 30 days).
Pressure injury incidence density
Number of new pressure injuries per 1,000 patient-days.
Time frame: From ICU admission through ICU discharge (up to 30 days).
Pressure injury deterioration rate
Proportion of existing pressure injuries that progress to a more severe stage during ICU stay.
Time frame: From ICU admission through ICU discharge (up to 30 days).
Pressure injury deterioration density
Number of deteriorated pressure injuries per 1,000 patient-days.
Time frame: From ICU admission through ICU discharge (up to 30 days).
Economic evaluation: Total care costs
Total direct and indirect care costs during ICU stay, reported in U.S. dollars (USD).
Time frame: Through study completion, up to 30 days after ICU discharge.
Pressure injury-free days
Number of days without a new pressure injury during ICU stay.
Time frame: From ICU admission through ICU discharge (up to 30 days).
Economic evaluation:Labor costs
Nursing and staff labor costs related to turning and positioning, reported in U.S. dollars (USD)
Time frame: From ICU admission through ICU discharge (up to 30 days).
Economic evaluation:Equipment costs
Equipment-related costs (e.g., mattress and positioning aids), reported in U.S. dollars (USD).
Time frame: Through study completion, up to 30 days after ICU discharge.
Economic evaluation: Cost-effectiveness ratio
Incremental cost-effectiveness ratio comparing intervention and control groups.
Time frame: Through study completion, up to 30 days after ICU discharge.
Economic evaluation : Cost-benefit ratio
Cost-benefit ratio comparing intervention and control groups.
Time frame: Through study completion, up to 30 days after ICU discharge
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