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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HSFM + Manual Turning (Standard Care) | Active Comparator | ICU patients are placed on a high-specification foam mattress with scheduled manual repositioning per unit protocol (target every 2 hours using pillows). All other care follows unit protocols. |
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| TAPAM (Turn-Assist Alternating Pressure Air Mattress with Positioning Pillows) | Experimental | ICU patients receive a turn-assist alternating pressure air mattress that integrates pressure redistribution with automated lateral turning at preset intervals with positioning pillows. The mattress is used continuously during the ICU stay. All other care follows unit protocols. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAPAM | Device | Device: Turn-Assist Alternating Pressure Air Mattress (TAPAM) Automated lateral turning with pressure redistribution. |
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| Measure | Description | Time Frame |
|---|---|---|
| Manpower requirements for turning and positioning | Number of staff members required for each turning episode. | 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. | 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). | Through ICU stay, up to 30 days (average per patient). |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of new pressure injuries | Proportion of patients developing a new pressure injury (Stage 1-4) during ICU stay. | From ICU admission through ICU discharge (up to 30 days). |
| Pressure injury incidence density |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | At 3 months after implementation of the intervention. |
| Patient comfort and satisfaction with TAPAM |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wei Ling Hsuai, PhD | Contact | +886-23123456 | 263141 | hsiao0603@ntuh.gov.tw |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital | Taipei | Taiwan |
Individual participant data (IPD) will not be shared. The study results will be disseminated only in aggregate form through publications and conference presentations. The decision not to share IPD is based on data privacy considerations and institutional policy restrictions.
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| HSFM | Device | Device: High-Specification Foam Mattress (HSFM) Standard ICU care support surface. |
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| Manual Turning (with pillows, per protocol) | Other | Nurse-performed scheduled manual turning (target every 2 hours, with pillows). |
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| Positioning Pillows | Other | Supplemental pillows used to support and maintain patient position. |
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Number of new pressure injuries per 1,000 patient-days.
| 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. | From ICU admission through ICU discharge (up to 30 days). |
| Pressure injury deterioration density | Number of deteriorated pressure injuries per 1,000 patient-days. | 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). | 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. | 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) | 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). | Through study completion, up to 30 days after ICU discharge. |
| Economic evaluation: Cost-effectiveness ratio | Incremental cost-effectiveness ratio comparing intervention and control groups. | Through study completion, up to 30 days after ICU discharge. |
| Economic evaluation : Cost-benefit ratio | Cost-benefit ratio comparing intervention and control groups. | Through study completion, up to 30 days after ICU discharge |
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). |
| At ICU discharge (up to 30 days after ICU admission). |
| Adverse events related to TAPAM | Incidence of events such as tube dislodgement, device malfunction, or electrical failure during use. | From device initiation through ICU discharge (up to 30 days). |