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NCT Number: NCT07141134

Turnova: The Clinical Efficacy, Manpower Reduction, and Cost-Effectiveness of Turn-Assist Alternating Pressure Air Mattresses for Pressure Injury Prevention in the ICU

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.

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Key information

Conditions

Critical Care, Intensive Care Cost Analysis Nursing Workload

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan University Hospital

Taipei, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

TAPAM

Device

Device: Turn-Assist Alternating Pressure Air Mattress (TAPAM) Automated lateral turning with pressure redistribution.

HSFM

Device

Device: High-Specification Foam Mattress (HSFM) Standard ICU care support surface.

Manual Turning (with pillows, per protocol)

Other

Nurse-performed scheduled manual turning (target every 2 hours, with pillows).

Positioning Pillows

Other

Supplemental pillows used to support and maintain patient position.

Primary outcomes

  1. Manpower requirements for turning and positioning

    Time frame: Through ICU stay, up to 30 days (average per patient).

    Number of staff members required for each turning episode.

  2. Time spent on turning and positioning

    Time frame: Through ICU stay, up to 30 days (average per patient).

    Duration (in minutes) from start to completion of each turning episode.

  3. Perceived exertion of turning task

    Time frame: 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).

Secondary outcomes

  1. Incidence of new pressure injuries

    Time frame: From ICU admission through ICU discharge (up to 30 days).

    Proportion of patients developing a new pressure injury (Stage 1-4) during ICU stay.

  2. Pressure injury incidence density

    Time frame: From ICU admission through ICU discharge (up to 30 days).

    Number of new pressure injuries per 1,000 patient-days.

  3. Pressure injury deterioration rate

    Time frame: From ICU admission through ICU discharge (up to 30 days).

    Proportion of existing pressure injuries that progress to a more severe stage during ICU stay.

  4. Pressure injury deterioration density

    Time frame: From ICU admission through ICU discharge (up to 30 days).

    Number of deteriorated pressure injuries per 1,000 patient-days.

  5. Economic evaluation: Total care costs

    Time frame: Through study completion, up to 30 days after ICU discharge.

    Total direct and indirect care costs during ICU stay, reported in U.S. dollars (USD).

  6. Pressure injury-free days

    Time frame: From ICU admission through ICU discharge (up to 30 days).

    Number of days without a new pressure injury during ICU stay.

  7. Economic evaluation:Labor costs

    Time frame: From ICU admission through ICU discharge (up to 30 days).

    Nursing and staff labor costs related to turning and positioning, reported in U.S. dollars (USD)

  8. Economic evaluation:Equipment costs

    Time frame: Through study completion, up to 30 days after ICU discharge.

    Equipment-related costs (e.g., mattress and positioning aids), reported in U.S. dollars (USD).

  9. Economic evaluation: Cost-effectiveness ratio

    Time frame: Through study completion, up to 30 days after ICU discharge.

    Incremental cost-effectiveness ratio comparing intervention and control groups.

  10. Economic evaluation : Cost-benefit ratio

    Time frame: Through study completion, up to 30 days after ICU discharge

    Cost-benefit ratio comparing intervention and control groups.

Other outcomes

  1. Nurse satisfaction with TAPAM

    Time frame: At 3 months after implementation of the intervention.

    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).

  2. Patient comfort and satisfaction with TAPAM

    Time frame: At ICU discharge (up to 30 days after ICU admission).

    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).

  3. Adverse events related to TAPAM

    Time frame: From device initiation through ICU discharge (up to 30 days).

    Incidence of events such as tube dislodgement, device malfunction, or electrical failure during use.

Study contacts

Contact information is provided by the study sponsor or research team.

Wei Ling Hsuai, PhD

CONTACT

[email protected]

+886-23123456 ext. 263141

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 26, 2025
Registry last updated
Sep 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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