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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNational Taiwan University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Repeat ICU admission during the study period.

Unstable spinal fracture.

Receiving cervical or skeletal traction.

Body weight >180 kg (exceeds mattress weight limit).

Trial design

Design model

Parallel

Treatments tested in this trial

  • TAPAM

    Device

    Device: Turn-Assist Alternating Pressure Air Mattress (TAPAM) Automated lateral turning with pressure redistribution.

  • HSFM

    Device

    Device: High-Specification Foam Mattress (HSFM) Standard ICU care support surface.

  • Manual Turning (with pillows, per protocol)

    Other intervention

    Nurse-performed scheduled manual turning (target every 2 hours, with pillows).

  • Positioning Pillows

    Other intervention

    Supplemental pillows used to support and maintain patient position.

Treatment groups

236 Participants
are divided into 2 treatment groups
Group A: HSFM + Manual Turning (Standard Care)Active comparator 2 interventions
Group B: TAPAM (Turn-Assist Alternating Pressure Air Mattress with Positioning Pillows)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Manpower requirements for turning and positioning

Number of staff members required for each turning episode.

Time frame
Through ICU stay, up to 30 days (average per patient).
2

Time spent on turning and positioning

Duration (in minutes) from start to completion of each turning episode.

Time frame
Through ICU stay, up to 30 days (average per patient).
3

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).

Time frame
Through ICU stay, up to 30 days (average per patient).

Secondary outcomes

1

Incidence of new pressure injuries

Proportion of patients developing a new pressure injury (Stage 1-4) during ICU stay.

Time frame
From ICU admission through ICU discharge (up to 30 days).
2

Pressure injury incidence density

Number of new pressure injuries per 1,000 patient-days.

Time frame
From ICU admission through ICU discharge (up to 30 days).
3

Pressure injury deterioration rate

Proportion of existing pressure injuries that progress to a more severe stage during ICU stay.

Time frame
From ICU admission through ICU discharge (up to 30 days).
4

Pressure injury deterioration density

Number of deteriorated pressure injuries per 1,000 patient-days.

Time frame
From ICU admission through ICU discharge (up to 30 days).

Other outcomes

1

Nurse satisfaction with TAPAM

Satisfaction scores covering ease of use, functionality, and perceived clinical effectiveness, measured via structured questionnaire using a 5-point Likert scale (range 1-5; higher scores indicate greater satisfaction).

Time frame
At 3 months after implementation of the intervention.
2

Patient comfort and satisfaction with TAPAM

Patient-reported comfort and satisfaction scores with the mattress, measured via structured questionnaire (or proxy report if the patient is unable to respond), using a 5-point Likert scale (range 1-5; higher scores indicate greater satisfaction).

Time frame
At ICU discharge (up to 30 days after ICU admission).
3

Adverse events related to TAPAM

Incidence of events such as tube dislodgement, device malfunction, or electrical failure during use.

Time frame
From device initiation through ICU discharge (up to 30 days).

Sponsors and contacts

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