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临床试验/NCT07454746
NCT07454746已完成不适用

Validity and Reliability Study of the CALCULATE Pressure Injury Risk Scale in Intensive Care Unit Patients

Acibadem University1 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2024年10月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
76
试验地点
1
主要终点
Validity of the CALCULATE Pressure Injury Risk Assessment Scale

研究概览

简要总结

This study aimed to translate and culturally adapt the Critical Care Pressure Ulcer Assessment Tool Made Easy (CALCULATE) into Turkish and to evaluate its validity and reliability for use in ICU patients.

This study sought to answer the following questions:

Is the Turkish version of the CALCULATE Pressure Injury Risk Assessment Scale a valid instrument for determining the risk of pressure injury in patients hospitalized in the Intensive Care Unit (ICU)?

Is the Turkish version of the CALCULATE Pressure Injury Risk Assessment Scale a reliable instrument for determining the risk of pressure injury in patients hospitalized in the Intensive Care Unit (ICU)?

详细描述

Pressure injuries (PIs) are largely preventable adverse events that reduce patients' quality of life and create a substantial financial burden on healthcare systems. A PI is a localized injury to the skin and/or underlying tissue, usually over a bony prominence or related to a medical device, caused by pressure and/or shear forces.

Patients in intensive care units (ICUs) are among the most vulnerable groups because they are exposed to multiple risk factors, including immobility, sedation, mechanical ventilation, hemodynamic instability, and medical devices. As a result, the risk of developing PIs in the ICU is reported to be about four times higher than in other patient groups, and most cases occur between 5 and 25 days of hospitalization.

International evidence shows that PI prevalence and incidence are higher in ICUs than in general wards. PIs, especially advanced-stage injuries, are also associated with significantly increased treatment costs. In Türkiye, although rates vary across institutions, PI occurrence in ICUs remains clinically significant, and medical device-related pressure injuries (MDRPIs) constitute a considerable proportion of cases.

Preventing hospital-acquired PIs is widely accepted as an important indicator of healthcare quality and remains a major clinical priority. The 2025 EPUAP guideline emphasizes that risk assessment should be considered not only as a screening step but as a comprehensive clinical decision-making process that guides individualized preventive care plans. Although more than 40 instruments have been developed to assess PI risk, tools designed for general patient populations may not adequately reflect the unique risk profile of critically ill ICU patients.

Based on this rationale, a validity and reliability study of the CALCULATE Pressure Injury Risk Assessment Scale, which was developed in the United Kingdom, was conducted in Türkiye.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • participants were adults (≥ 18 years)
  • ICU length of stay of ≥24 h
  • No Pressure ınjury at admission

排除标准

  • Patients discharged before completing 24 hours in the ICU
  • Patients who were not cared for on specialized beds used in the ICU

研究组 & 干预措施

ICU Patients

Population consisted of patients admitted to a Level III Anesthesiology and Reanimation ICU

干预措施: ICU pressure injury prevention protocol as standard care (Other)

结局指标

主要结局

Validity of the CALCULATE Pressure Injury Risk Assessment Scale

时间窗: From ICU admission until ICU discharge, with daily risk assessments performed once every 24 hours during ICU stay.

Validity of the CALCULATE Pressure Injury Risk Assessment Scale for assessing pressure injury risk in ICU patients, evaluated using daily risk assessments during ICU stay and comparison with the Braden Scale. The Braden Scale used in clinical settings and generates a total score ranging from 6 to 23, with lower scores indicating a higher risk of PI development. According to the CALCULATE for Pressure Injury risk assessment total score, patients with ≥4 risk factors are categorized as "very high risk," whereas those with ≤3 risk factors are classified as "high risk"

Reliability of the CALCULATE Pressure Injury Risk Assessment Scale

时间窗: From ICU admission until ICU discharge, with daily risk assessments performed once every 24 hours during ICU stay.

Reliability of the CALCULATE Pressure Injury Risk Assessment Scale for assessing pressure injury risk in ICU patients, evaluated using daily risk assessments during ICU stay and comparison with the Braden Scale. The Braden Scale used in clinical settings and generates a total score ranging from 6 to 23, with lower scores indicating a higher risk of PI development. According to the CALCULATE for Pressure Injury risk assessment total score, patients with ≥4 risk factors are categorized as "very high risk," whereas those with ≤3 risk factors are classified as "high risk" .

次要结局

未报告次要终点

研究者

发起方
Acibadem University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ukke Karabacak

Professor

Acibadem University

研究点 (1)

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