Fluidized positioner versus memory foam pillow to prevent head pressure injuries in children
Comparison of the Effectiveness of Fluidized Positioner and Memory Foam Pillow in the Prevention of Pressure Injury in the Children's Head: A Randomised Controlled Study
NA · Koç University · NCT06977152
This trial will try a fluidized positioner versus a memory foam pillow to see which better prevents head pressure injuries in ventilated, immobile children in the pediatric ICU.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 28 Days to 5 Years |
| Sex | All |
| Sponsor | Koç University (other) |
| Locations | 1 site (Istanbul, Zeytinburnu) |
| Trial ID | NCT06977152 on ClinicalTrials.gov |
What this trial studies
This interventional study compares two head supports—a fluidized positioner and a memory foam pillow—in mechanically ventilated, immobile children aged 28 days to 5 years treated in a pediatric intensive care unit. Participants receive one of the two supports during their ICU stay and are monitored for new pressure injuries and local pressure measurements at occipital, parietal, temporal, and ear regions. Outcomes include incidence of pressure injury, measured pressure on head regions, and pressure distribution homogeneity between devices. The study is conducted at Koç University Hospital and excludes patients with existing head PIs, recent head surgery, hydrocephalus, burns, or relevant skin/connective tissue diseases.
Who should consider this trial
Good fit: Mechanically ventilated, immobile children aged 28 days to 5 years treated in the pediatric ICU with guardian consent and no existing head pressure injuries are ideal candidates.
Not a fit: Children with existing head pressure injuries, recent head surgery, hydrocephalus, head burns, significant dermatologic/connective tissue disease, or who cannot provide sufficient monitoring data are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the fluidized positioner could lower the risk of head pressure injuries and protect vulnerable skin in pediatric ICU patients.
How similar studies have performed: Pressure-redistribution devices and specialized pillows have shown benefit in reducing pressure injuries in adult populations, but robust pediatric-specific evidence is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Being treated in the pediatric intensive care unit * Being mechanically ventilated * Being immobile, being in age interval of 28 days to 5 years * Having consent for the participation of the study Exclusion Criteria: * Having surgical intervention in the head region * Parents want to leave at any stage of the project * Having hydrocephalus or burn in the head area * Having PIs on admission to hospital * Existing dermatologic diseases affecting the skin or connective tissue * Having emergence of a new condition during the intervention may significantly affect the risk of pressure injury (e.g., sudden surgery or complication) * Inability to obtain sufficient data during the study (e.g., patient transfer)
Where this trial is running
Istanbul, Zeytinburnu
- Koç University Hospital — Istanbul, Zeytinburnu, Turkey (Türkiye) (RECRUITING)
Study contacts
- Principal investigator: Enes Şimşek, MSc. PhD(c) — Koç University
- Study coordinator: Enes Şimşek, MSc. PhD(c)
- Email: enessimsek19@ku.edu.tr
- Phone: +90 546 250 2050
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pressure Injury, pediatric patients, Pressure injury, Risk assessment, foam pillow, fluidized positioner