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临床试验/ISRCTN01151335
ISRCTN01151335已完成未知

Pressure RElieving Support SUrfaces: a Randomised Evaluation 2

niversity of Leeds (UK)0 个研究点目标入组 2,029 人开始时间: 2013年5月14日最近更新:
适应症

试验速览

阶段
未知
状态
已完成
发起方
入组人数
2,029

研究概览

简要总结

2016 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/27993145 2017 photographic validation sub-study protocol in: https://www.ncbi.nlm.nih.gov/pubmed/28320482 2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/31559948 (added 01/10/2019) 2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/31709401 (added 13/11/2019) 2021 results in https://pubmed.ncbi.nlm.nih.gov/33910607/ (added 30/04/2021)

研究设计

研究类型
Interventional

入排标准

性别
All

入选标准

  • •Current inclusion criteria as of 04/07/2014:
  • •1. Evidence of acute illness through:
  • •1.1. Acute admission to secondary care hospital, community hospital or NHS-funded intermediate care/rehabilitation facility
  • •1.2. Secondary care, community hospital or NHS-funded intermediate care/rehabilitation facility in-patient with onset of acute illness secondary to elective admission
  • •1.3. Recent secondary care hospital discharge to community hospital or NHS-funded intermediate care/ rehabilitation facility
  • •2. Aged 18 years or over, either sex
  • •3. Have an expected total length of stay of 5 or more days
  • •4. At high risk of PU development due to one or more of the following:
  • •4.1. Bedfast/chairfast AND completely immobile/very limited mobility (Braden Activity score 1 or 2 and Mobility score 1 or 2)
  • •4.2. Category 1 PU on any pressure area skin site
  • •4.3. Localised skin pain on any pressure area skin site
  • •5. Consent to participate (written, informed consent/witnessed verbal consent/consultee agreement)
  • •6. Expected to be able to comply with follow-up schedule
  • •Previous inclusion criteria:
  • •1. Acute hospital admission under the care of a vascular, orthopaedic, surgery, medical or care of the elderly hospital consultant; or community hospital admission (i.e., rehabilitation ward/unit) receiving consultant-led care
  • •2. Aged 18 years or over, either sex
  • •3. Have an expected total length of stay of 5 or more days
  • •4. At high risk of PU development due to one or more of the following:
  • •4.1. Bedfast/chairfast AND completely immobile/very limited mobility (Braden Activity score 1 or 2 and Mobility score 1 or 2)
  • •4.2. Category 1 PU on any pressure area skin site
  • •4.3. Localised skin pain on any pressure area skin site
  • •5. Consent to participate (written, informed consent/witnessed verbal consent/consultee agreement)
  • •6. Expected to be able to comply with follow-up schedule.

排除标准

  • •Current exclusion criteria as of 04/07/2014:
  • •1. Have previously participated in the Pressure 2 trial
  • •2. Have a current or previous Category 3 or greater PU
  • •3. Have planned admission to ICU (where standard care is alternating pressure mattress provision)
  • •4. Unable to receive the intervention (for example, sleep at night in a chair or unable to be transferred to randomised mattress)
  • •5. Patient weight is lower or higher than weight limits for HSF and alternating pressure mattresses (<45 kg/>180 kg)
  • •6. It is ethically inappropriate to approach the patient
  • •Previous exclusion criteria:
  • •1. Acute hospital admission under the care of the General Practitioner
  • •2. Have previously participated in the trial
  • •3. Have a current or previous Category 3 or greater PU
  • •4. Have planned admission to ICU (where standard care is alternating pressure mattress provision)
  • •5. Unable to receive the intervention (for example, sleep at night in a chair or unable to be transferred to randomised mattress)
  • •6. Patient weight is lower or higher than weight limits for HSF and alternating pressure mattresses (<45 kg/>180 kg)

研究者

发起方
niversity of Leeds (UK)

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