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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Pressure Injury Development
研究概览
简要总结
This study aims to compare the effectiveness of fluidized positioners and memory foam pillows in preventing pressure injuries in the head among pediatric patients.
H1: There is a significant difference between the fluidized positioner and the memory foam pillow in terms of pressure injury incidence in pediatric intensive care patients.
H2: The fluidized positioner reduces the risk of developing pressure injuries more effectively than the memory foam pillow.
H3: There is a significant difference in the pressure applied to the head region of the patient between the fluidized positioner and the memory foam pillow.
H4: The anatomical locations of pressure injuries (occipital, parietal, temporal, and ear regions) vary depending on the type of pillow used.
H5: Compared to the memory foam pillow, the fluidized positioner is associated with a more homogeneous pressure distribution across the occipital, parietal, and temporal regions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 28 Days 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
Fluidized positioner
Patients in the experimental group will have a fluidized positioner placed under their head and neck immediately after the initiation of mechanical ventilation support in the PICU.
干预措施: Fluidized Positioner (Device)
Memory foam pillow
Patients in the comparison group will have a memory foam pillow placed under their head and neck immediately after the initiation of mechanical ventilation support in the PICU.
干预措施: Memory foam pillow (Device)
结局指标
主要结局
Pressure Injury Development
时间窗: 0-14 days after the beginning of mechanical ventilation support
The study will compare the incidence, stage, and anatomical location of PIs between the two groups.
次要结局
- Pressure Measurement(1st day, 7th day and 14th day of use of support surfaces.)
研究者
Enes Simsek
Principal Investigator
Koç University