NCT07141134

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 236 (estimated)
• Sponsor: National Taiwan University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Critical Care, Intensive Care
• Nursing Workload
• Cost Analysis

Interventions

Type	Name	Description
DEVICE	TAPAM	Device: Turn-Assist Alternating Pressure Air Mattress (TAPAM) Automated lateral turning with pressure redistribution.
DEVICE	HSFM	Device: High-Specification Foam Mattress (HSFM) Standard ICU care support surface.
OTHER	Manual Turning (with pillows, per protocol)	Nurse-performed scheduled manual turning (target every 2 hours, with pillows).
OTHER	Positioning Pillows	Supplemental pillows used to support and maintain patient position.

Timeline

• Start date: 2025-09-08
• Primary completion: 2026-06-27
• Completion: 2026-07-30
• First posted: 2025-08-26
• Last updated: 2025-09-08

Locations

1 site across 1 country: Taiwan