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A randomised controlled trial of a turning and positioning system for the prevention of pressure injuries in the Intensive Care Unit

A randomised controlled trial of a turning and positioning system for the prevention of pressure injuries in the Intensive Care Unit

Status
Terminated
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12619000156189
Acronym
TaP ICU
Enrollment
78
Registered
2019-02-04
Start date
2019-08-14
Completion date
2020-05-27
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The aim of the study is to determine the clinical effectiveness of a system for turning and positioning Intensive Care Unit (ICU) patients, when compared to usual care turning and positioning devices, for preventing pressure injuries.

Interventions

Mölnlycke® Tortoise Turning and Positioning System. This system is comprised of two devices, a Turning Pad and a Fluidized Positioner. The Turning Pad is used to position people in bed (move them up and down the bed, across the bed and to roll them over). The Fluidized Positioner is used to support the body while in bed, in this study propped behind the back when the patient is laying in the side lying lateral position. The turning pad is made of nylon, polyester, polyurethane and cotton. Th

Mölnlycke® Tortoise Turning and Positioning System. This system is comprised of two devices, a Turning Pad and a Fluidized Positioner. The Turning Pad is used to position people in bed (move them up and down the bed, across the bed and to roll them over). The Fluidized Positioner is used to support the body while in bed, in this study propped behind the back when the patient is laying in the side lying lateral position. The turning pad is made of nylon, polyester, polyurethane and cotton. The fluidized positioner is comprised of a polyurethane (a common type of plastic) bag which contains predominantly Polydimethylsiloxane (a viscous fluid mix). The Turning and Positioning System may be used by nurses, personal care workers, physiotherapists and doctors. In this study the Turning and Positioning System will be used by nurses and ward support staff (of the Intensive Care Unit at The Northern Hospital) who are involved in the turning and positioning of patients. Patients are typically turned and positioned every 2-4 hours. The Turning and Positioning System will be used for the duration of the participants stay in the ICU, which is on average 2 days. The system will be in use at all times when the participant is in bed.

Sponsors

The University of Melbourne
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Single group
Primary purpose
Prevention
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

The inclusion criteria are: • >18 years of age • ICU admission for critical illness or trauma • High risk of pressure injury development (a score of <12) according to the Braden Scale for Predicting Pressure Sore Risk (Bergstrom, Braden, Laguzza, & Holman, 1987).

Exclusion criteria

The exclusion criteria are: • Has a sacral, ischial tuberosity or buttock pressure injury • Trauma to sacrum, ischial tuberosity or buttock • Suspected or actual spinal injury precluding the patient being turned or requiring immobilization • Has injuries that are not survivable or is receiving palliation • Known sensitivity to nylon, polyester, polyurethane or cotton.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026