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临床试验/NCT03270345
NCT03270345已完成不适用

Multicentre International One-Day Prevalence Study on Pressure Injuries in Intensive Care Units

European Society of Intensive Care Medicine1 个研究点 分布在 1 个国家目标入组 13,340 人开始时间: 2018年5月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
13,340
试验地点
1
主要终点
major risk factors for pressure injury development.

研究概览

简要总结

The objective of this study is to provide an up-to-date, global picture of the extent and patterns of pressure injuries in ICUs. Point prevalence studies are only of value when performed on a vast scale. To sample a representative cohort, it is the intention to recruit about 1200 ICUs with all continents covered and as many countries as possible within each continent.

详细描述

The objective is to provide an up-to-date, international "global" picture of the extent and patterns of pressure injuries in ICUs. Thereto , the plan is to perform a 1-day, prospective, multicenter point-prevalence study. The large scale of the project should allow thorough epidemiological analyses. More precisely the study will enable to identify:

  • major risk factors for pressure ulcer development;
  • preventive measures used in distinct ICU populations and countries;
  • shortages in the availability of evidence-based measures to prevent pressure sores;
  • malpractice pressure sore prevention in particular regions or countries;
  • occurrence rates of pressure ulcers with/without accurate adjustment for risk profile and preventive measures taken;
  • benchmarking between regions/countries; clinical outcomes associated with pressure ulcers (major organ derangements and mortality);
  • economic outcomes associated with pressure ulcers (length of ICU stay) and linking these outcomes with local practice regarding prevention measures applied/available.
  • country and regional differences in prevalence of pressure ulcers and outcome.

Pressures ulcer stages will be graded following the classification system jointly developed by the National Pressure Ulcer Advisory Panel and European Pressure Ulcer Advisory Panel.

Data to be recorded include patient demographics, data on severity of underlying disease and acute illness, organ failure, pressure ulcers, major risk factors for pressure ulcers, and measures taken to prevent pressure ulcers.

Statistical Plan

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

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

  • All adult patients (>18 years of age) present on the date of data collection

排除标准

  • There are no exclusion criteria. All patients should be included. Patients with severe clinical conditions not allowing safe pressure ulcer identification should not be evaluated for the respective risk zones. If it is known that the patient has a pressure ulcer at the body sites that cannot be safely evaluated, the stage of the pressure ulcer should be recorded as previously known. If it is unknown whether the patient has a pressure ulcer at these body sites, this should be indicated with a '?' in the Case Report Form

结局指标

主要结局

major risk factors for pressure injury development.

时间窗: on the data collection day of 18 May 2018 (84 days follow-up)

Pressures injury stages will be graded following the classification system jointly developed by the National Pressure Ulcer Advisory Panel, European Pressure Ulcer Advisory Panel, and Pan Pacific Pressure Injury Alliance. Data to be recorded include patient demographics, data on severity of underlying disease and acute illness, organ failure, pressure ulcers, major risk factors for pressure ulcers, and measures taken to prevent pressure injuries.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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