Evaluation of the Efficacy of Two Levels of Frequency of Repositioning in Adults Hospitalized in Intensive Care Units, in the Reduction of Pressure Ulcers: A Randomized Cluster Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 3,300
- 试验地点
- 21
- 主要终点
- The incidence (incidence rata ration) of new pressure ulcers in each Intensive Care Unit (ICU)
研究概览
简要总结
PENFUP FASE 2, It is a multicenter study by parallel conglomerates, planned in order to evaluate the efficacy between two levels of frequency of postural change in intensive care units for adults of hospitals in various regions of Colombia.
详细描述
Taking into account a design effect of 6.7, Investigators planned to include 150 participants from each ICU. Investigators did calculate that a total of 22 ICUs are required, in which 11 will be assigned to the low frequency and 11 will be assigned to a high frequency group of postural change until obtaining a total of 1,650 patients in each arm of the study and a total of 3,300 participants in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Telephone randomization Random numbers centers Blinded for analyst and researchers
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The ICU manage adult patients, over 18 years of age, with any type of emphasis (surgical, medical, neurological, or mixed);
- •Patients are admitted in critical condition (with life support);
- •The director accepts the commitment of the care assigned in the randomization (for a period of 3 months).
排除标准
- •Intermediate care units in which patients mobilize themselves.
- •Covid patients or other patients exposed to different mobilization patterns (e.g., 12 hours prone vs 12 supine)
研究组 & 干预措施
High frequency postural change
Repositioning or rotation of patients hospitalized in bed in intensive care units will be carried out with a frequency interval that we call "high-frequency". It has to be performed on each patient between an interval less than or equal to every 2 hours in a full day (24 hours) (minimum goal of 8-10 in 24 hours subtracting 2 or 4 at night and not alter the circadian cycle). The position must be modified in each postural change to the right lateral, supine, left lateral, supine, or prone position to supine position. The repositioning will be provided until a patient is discharged from ICU, die or begin ambulation. When providing each repositioning, avoid dragging the patient, the shear, and the friction to increase UPP risk. This must be applied to avoiding massage. Patients in any position should use pressure-reducing items such as pillows.
干预措施: High frequency postural change (Other)
Conventional care
Repositioning or rotation of patients hospitalized will be the conventional or usual care. Units in this group are not going to receive any intervention. Will be only observed in their current intervention of repositioning.
干预措施: Conventional care (Other)
结局指标
主要结局
The incidence (incidence rata ration) of new pressure ulcers in each Intensive Care Unit (ICU)
时间窗: " 1 month after admission"
The number of pressure injuries at any stage, new acquired in the ICU after admission per 1,000 patient days in the ICU.
次要结局
- Security outcomes("1 month after admission")
- Risk index (HR) and time to event of Pressure ulcers of the patients("1 month safter admission")
研究者
Olga Cortés, RN, MSc, PhD
Reseear Associated, Research Department, Principal Investigator
Fundación Cardioinfantil Instituto de Cardiología