Turnova: The Clinical Efficacy, Manpower Reduction, and Cost-Effectiveness of Turn-Assist Alternating Pressure Air Mattresses for Pressure Injury Prevention in the ICU
NCT ID: NCT07141134
Last Updated: 2025-09-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
236 participants
INTERVENTIONAL
2025-09-08
2026-07-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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HSFM + Manual Turning (Standard Care)
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.
HSFM
Device: High-Specification Foam Mattress (HSFM) Standard ICU care support surface.
Manual Turning (with pillows, per protocol)
Nurse-performed scheduled manual turning (target every 2 hours, with pillows).
TAPAM (Turn-Assist Alternating Pressure Air Mattress with Positioning Pillows)
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.
TAPAM
Device: Turn-Assist Alternating Pressure Air Mattress (TAPAM) Automated lateral turning with pressure redistribution.
Positioning Pillows
Supplemental pillows used to support and maintain patient position.
Interventions
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TAPAM
Device: Turn-Assist Alternating Pressure Air Mattress (TAPAM) Automated lateral turning with pressure redistribution.
HSFM
Device: High-Specification Foam Mattress (HSFM) Standard ICU care support surface.
Manual Turning (with pillows, per protocol)
Nurse-performed scheduled manual turning (target every 2 hours, with pillows).
Positioning Pillows
Supplemental pillows used to support and maintain patient position.
Eligibility Criteria
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Inclusion Criteria
* Admission time between 08:00 and 23:00.
* Clinical condition requires ICU-level care.
Exclusion Criteria
* Unstable spinal fracture.
* Receiving cervical or skeletal traction.
* Body weight \>180 kg (exceeds mattress weight limit).
* Declines participation in the study.
18 Years
ALL
No
Sponsors
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National Taiwan University Hospital
OTHER
Responsible Party
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Locations
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National Taiwan University Hospital
Taipei, , Taiwan
Countries
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Central Contacts
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Other Identifiers
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202505127DIPD
Identifier Type: -
Identifier Source: org_study_id
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