Critical Care, Intensive CareNCT07141134
Turnova: The Clinical Efficacy, Manpower Reduction, and Cost-Effectiveness of Turn-Assist Alternating Pressure Air Mattresses for Pressure Injury Prevention in the ICU
A study testing TAPAM, HSFM and Manual Turning (with pillows, per protocol) in people with Critical Care, Intensive Care and Nursing Workload, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Care, Intensive Care, Nursing Workload, Cost Analysis
- What is being tested?
- TAPAM, HSFM and Manual Turning (with pillows, per protocol)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 236 participants
- Where
- 1 siteTaiwan
- Study dates
- 8 Sep 2025to 30 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the detailed description
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.
- Being tested
- TAPAM, HSFM, Manual Turning (with pillows, per protocol), Positioning Pillows
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAPAMDevice
Device: Turn-Assist Alternating Pressure Air Mattress (TAPAM) Automated lateral turning with pressure redistribution.
HSFMDevice
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 PillowsOther
Supplemental pillows used to support and maintain patient position.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: HSFM; Other: Manual Turning (with pillows, per protocol) |
| 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. Receives: Device: TAPAM; Other: Positioning Pillows |
What is being measured
The primary outcome is the main question the study is designed to answer.
Manpower requirements for turning and positioning
Number of staff members required for each turning episode.
Measured: 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.
Measured: 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).
Measured: Through ICU stay, up to 30 days (average per patient).
Secondary outcomes (10)
Incidence of new pressure injuries
Proportion of patients developing a new pressure injury (Stage 1-4) during ICU stay.
Measured: From ICU admission through ICU discharge (up to 30 days).
Pressure injury incidence density
Number of new pressure injuries per 1,000 patient-days.
Measured: 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.
Measured: From ICU admission through ICU discharge (up to 30 days).
Pressure injury deterioration density
Number of deteriorated pressure injuries per 1,000 patient-days.
Measured: 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).
Measured: 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.
Measured: 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)
Measured: 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).
Measured: Through study completion, up to 30 days after ICU discharge.
Economic evaluation: Cost-effectiveness ratio
Incremental cost-effectiveness ratio comparing intervention and control groups.
Measured: Through study completion, up to 30 days after ICU discharge.
Economic evaluation : Cost-benefit ratio
Cost-benefit ratio comparing intervention and control groups.
Measured: Through study completion, up to 30 days after ICU discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2025
- Study start8 Sep 2025 (estimated)
- Primary completion27 Jun 2026 (estimated)
- Study completion30 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical Care, Intensive CareStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 236 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07141134
- Sponsor's protocol ID
- 202505127DIPD
- Status last verified
- Sep 2025
- First submitted
- 12 Aug 2025
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Turnova: The Clinical Efficacy, Manpower Reduction, and Cost-Effectiveness of Turn-Assist Alternating Pressure Air Mattresses for Pressure Injury Prevention in the ICU
- ClinicalTrials.gov ID
- NCT07141134
- Acronym / sponsor ID
- 202505127DIPD
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 236 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 8 Sep 2025 (estimated)
- Primary completion
- 27 Jun 2026 (estimated)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 26 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HSFM + Manual Turning (Standard Care) | Active comparator | Device: HSFM, Other: Manual Turning (with pillows, per protocol)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. |
| TAPAM (Turn-Assist Alternating Pressure Air Mattress with Positioning Pillows) | Experimental | Device: TAPAM, Other: Positioning PillowsICU 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TAPAMDevice: Turn-Assist Alternating Pressure Air Mattress (TAPAM) Automated lateral turning with pressure redistribution. | Device | TAPAM (Turn-Assist Alternating Pressure Air Mattress with Positioning Pillows) |
| HSFMDevice: High-Specification Foam Mattress (HSFM) Standard ICU care support surface. | Device | HSFM + Manual Turning (Standard Care) |
| Manual Turning (with pillows, per protocol)Nurse-performed scheduled manual turning (target every 2 hours, with pillows). | Other | HSFM + Manual Turning (Standard Care) |
| Positioning PillowsSupplemental pillows used to support and maintain patient position. | Other | TAPAM (Turn-Assist Alternating Pressure Air Mattress with Positioning Pillows) |
Primary outcome
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.
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.
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).
10 secondary outcomes
Incidence of new pressure injuries
Time frame: From ICU admission through ICU discharge (up to 30 days).
Pressure injury incidence density
Time frame: From ICU admission through ICU discharge (up to 30 days).
Pressure injury deterioration rate
Time frame: From ICU admission through ICU discharge (up to 30 days).
Pressure injury deterioration density
Time frame: From ICU admission through ICU discharge (up to 30 days).
Economic evaluation: Total care costs
Time frame: Through study completion, up to 30 days after ICU discharge.
Pressure injury-free days
Time frame: From ICU admission through ICU discharge (up to 30 days).
Economic evaluation:Labor costs
Time frame: From ICU admission through ICU discharge (up to 30 days).
Economic evaluation:Equipment costs
Time frame: Through study completion, up to 30 days after ICU discharge.
Economic evaluation: Cost-effectiveness ratio
Time frame: Through study completion, up to 30 days after ICU discharge.
Economic evaluation : Cost-benefit ratio
Time frame: Through study completion, up to 30 days after ICU discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TAPAM, HSFM and Manual Turning (with pillows, per protocol) in people with Critical Care, Intensive Care and Nursing Workload, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wei Ling Hsuai, PhD (+886-23123456 ext. 263141, hsiao0603@ntuh.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Manpower requirements for turning and positioning (time frame: Through ICU stay, up to 30 days (average per patient).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025.