Clinical Trial

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

Not Yet Recruiting
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Record status
This record was last updated September 8, 2025 (before its estimated June 27, 2026 completion). Its status may not reflect the trial's current state.
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. 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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-08-18.
Trial Details
NCT Number NCT07141134
Lead Sponsor National Taiwan University Hospital
Conditions Critical Care, Intensive Care, Nursing Workload, Cost Analysis
Enrollment 236 participants
Start Date 2025-09-08
Primary Completion 2026-06-27 (estimated)
Study Completion 2026-07-30 (estimated)
Updated on ClinicalTrials.gov 2025-09-08