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

National Taiwan University

Status: Not yet enrolling

Conditions: Nursing Workload; Critical Care, Intensive Care; Cost Analysis

Treatments: Other: Positioning Pillows; Device: HSFM; Other: Manual Turning (with pillows, per protocol); Device: TAPAM

Study type: Interventional

Funder types: Other

Identifiers

NCT07141134

202505127DIPD

Details and patient eligibility

About

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.

Full 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.

Enrollment: 236 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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236 participants in 2 patient groups

HSFM + Manual Turning (Standard Care)

Active Comparator group

Description:

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.

Treatment:

Other: Manual Turning (with pillows, per protocol)

Device: HSFM

TAPAM (Turn-Assist Alternating Pressure Air Mattress with Positioning Pillows)

Experimental group

Description:

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.

Treatment:

Device: TAPAM

Other: Positioning Pillows