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

NCT07141134 | Not Yet Recruiting

• 1 other identifier: 202505127DIPD
• Study Type: interventional
• Target: 236
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Critical Care, Intensive Care; Nursing Workload; Cost Analysis

Outcome Measures

Primary Outcomes (3)

• Manpower requirements for turning and positioning

  Number of staff members required for each turning episode.

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

• Time spent on turning and positioning

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

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

• 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).

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

Secondary Outcomes (10)

• Incidence of new pressure injuries

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

• Pressure injury incidence density

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

• Pressure injury deterioration rate

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

• Pressure injury deterioration density

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

• Economic evaluation: Total care costs

  Through study completion, up to 30 days after ICU discharge.

Other Outcomes (3)

• Nurse satisfaction with TAPAM

  At 3 months after implementation of the intervention.

• Patient comfort and satisfaction with TAPAM

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

• Adverse events related to TAPAM

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

Study Arms (2)

HSFM + Manual Turning (Standard Care)

ACTIVE COMPARATOR

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.

Device: HSFM; Other: Manual Turning (with pillows, per protocol)

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

EXPERIMENTAL

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.

Device: TAPAM; Other: Positioning Pillows

Interventions

TAPAM DEVICE

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

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

HSFM DEVICE

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

HSFM + Manual Turning (Standard Care)

Manual Turning (with pillows, per protocol) OTHER

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

HSFM + Manual Turning (Standard Care)

Positioning Pillows OTHER

Supplemental pillows used to support and maintain patient position.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

Location

Central Study Contacts

Wei Ling Hsuai, PhD

CONTACT

+886-23123456; hsiao0603@ntuh.gov.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2025
• First Posted: August 26, 2025
• Study Start: September 8, 2025
• Primary Completion (Estimated): June 27, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: September 8, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)