About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patients (≥18 years old) admitted to medical or surgical intensive care units (ICUs).
Admission time between 08:00 and 23:00.
Clinical condition requires ICU-level care.
Disqualifiers
Repeat ICU admission during the study period.
Unstable spinal fracture.
Receiving cervical or skeletal traction.
Body weight >180 kg (exceeds mattress weight limit).
Trial design
Parallel
Treatments tested in this trial
TAPAM
DeviceDevice: Turn-Assist Alternating Pressure Air Mattress (TAPAM) Automated lateral turning with pressure redistribution.
HSFM
DeviceDevice: High-Specification Foam Mattress (HSFM) Standard ICU care support surface.
Manual Turning (with pillows, per protocol)
Other interventionNurse-performed scheduled manual turning (target every 2 hours, with pillows).
Positioning Pillows
Other interventionSupplemental pillows used to support and maintain patient position.
Treatment groups
Trial outcomes
Primary outcomes
Manpower requirements for turning and positioning
Number of staff members required for each turning episode.
Time spent on turning and positioning
Duration (in minutes) from start to completion of each turning episode.
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).
Secondary outcomes
Incidence of new pressure injuries
Proportion of patients developing a new pressure injury (Stage 1-4) during ICU stay.
Pressure injury incidence density
Number of new pressure injuries per 1,000 patient-days.
Pressure injury deterioration rate
Proportion of existing pressure injuries that progress to a more severe stage during ICU stay.
Pressure injury deterioration density
Number of deteriorated pressure injuries per 1,000 patient-days.
Other outcomes
Nurse satisfaction with TAPAM
Satisfaction scores covering ease of use, functionality, and perceived clinical effectiveness, measured via structured questionnaire using a 5-point Likert scale (range 1-5; higher scores indicate greater satisfaction).
Patient comfort and satisfaction with TAPAM
Patient-reported comfort and satisfaction scores with the mattress, measured via structured questionnaire (or proxy report if the patient is unable to respond), using a 5-point Likert scale (range 1-5; higher scores indicate greater satisfaction).
Adverse events related to TAPAM
Incidence of events such as tube dislodgement, device malfunction, or electrical failure during use.
Sponsors and contacts
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