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临床试验/NCT02474979
NCT02474979
已完成
不适用

Reduced Pressure for Less Pressure Ulcers. Effect of the CBPM-system in a Swedish University Hospital

Uppsala University1 个研究点 分布在 1 个国家目标入组 190 人2015年3月

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Pressure Ulcer
发起方
Uppsala University
入组人数
190
试验地点
1
主要终点
PU prevalence (Category 1-4) - change from baseline
状态
已完成
最后更新
10年前

概览

简要总结

Pressure ulcers (PU) cause pain and discomfort to affected patients, as well as considerable costs for society. The present study will evaluate the effect of the Continuous Bedside Pressure Mapping (CBPM)- system on PU prevalence and incidence. A RCT including 180 patients will be conducted in a geriatric setting in a Swedish University hospital

详细描述

Background The first national PU prevalence study in Sweden conducted in 2011 showed a prevalence of 16.6% (n=16 466) in hospital settings. High age and reduced mobility/activity are main risk factors. International evidence-based guidelines for prevention of PU are available. Pressure relief (e.g repositioning, mattresses, chair cushions, heel cushions) is the main stay of preventive measures. Recent research shows that PU prevention is not a high priority. For example, the corner stone of prevention, repositioning, is not conducted for risk patients. Aim To evaluate the effect of the CBPM-system on the prevalence and incidence of PU in hospital setting Method Design: A randomised controlled trial will be conducted Sample: All patients admitted to the geriatric unit. Intervention: The CBPM-system will be used from admittance to discharge (not more than 14 days). Standard PU prevention (PU reducing mattress, floating heels, repositioning) Control group: Standard PU prevention (PU reducing mattress, floating heels, repositioning) Randomisation: Sealed envelopes will be used. Procedure: Two study nurses are responsible for inclusion of patients and data collection on day 1,3,7 and discharge. A photo will be taken of any PU. A PU expert will assess the photos after completed data collection (PU category 1-4). She will be blinded to group allocation. Power calculation: The primary outcome of interest is the PU prevalence. Previous point prevalence studies in this geriatric unit shows a prevalence of 45%. The investigators goal is that the CBPM-system results in 20% decrease in the PU prevalence. In order to have 80% power to detect such a decrease with a two-sided two-sample proportions test at the 5% level, 89 patients per treatment group is needed. Intention-to-treat principals will be used. Discussion The prevalence of PU, as well as prevention to risk patients are quality indicators in health care. National studies reveal an urgent need for quality improvement, New nursing methods and equipment must be systematically and scientifically evaluated.The results of this study will be valuable for nursing education and in international and national patient safety work to prevent PU. The results will also be valuable for other health professionals (physicians, physical and occupational therapists).

注册库
clinicaltrials.gov
开始日期
2015年3月
结束日期
2015年12月
最后更新
10年前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

发起方
Uppsala University
责任方
Sponsor

入排标准

入选标准

  • Admitted to geriatric unit 30A during Sunday after 4 pm to Friday until 4 pm

排除标准

  • Expected to be discharged before data collection in day 3

结局指标

主要结局

PU prevalence (Category 1-4) - change from baseline

时间窗: admission to discharge or last assessment at 14 days

The most severe PU for each patient is included in the calculation

次要结局

  • Number of PU per category and patient(admission to discharge or last assessment at 14 days)
  • Number of preventive interventions(admission to discharge or last assessment at 14 days)
  • Peak pressure(admission to discharge or last assessment at 14 days)
  • Patient´s experience of comfort in bed(admission to discharge or last assessment at 14 days)

研究点 (1)

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