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临床试验/NCT00847665
NCT00847665已完成3 期

Comparison of Two Turning Regimens (2 Versus Every 4 Hours) in the Prevention of Pressure Ulcers in Patients on Mechanical Ventilation That Use Alternating-pressure Air Mattresses.

University Hospital Virgen de las Nieves2 个研究点 分布在 1 个国家目标入组 330 人开始时间: 2009年2月1日最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
330
试验地点
2
主要终点
Incidence of Pressure Ulcer (PU) Grade ≥ II

研究概览

简要总结

The purpose of this study is to compare a 2-hour versus every 4-hour turning regimen on the incidence of grade > II pressure ulcers (PU) in patients in ICU on mechanical ventilation ≥ 24h that use alternating-pressure air mattresses (APAMs).

详细描述

Pressure ulcers (PUs) pose a major healthcare challenge and are associated with an increased risk of infection and sepsis, longer hospital stay, and higher hospitalization costs. Their reported incidence in critical care patients varies widely from 1% to 56%. Therefore it is important to take appropriate preventive measures, which can often be successful and less costly than the treatment of established ulcers. Among these measures are the use of pressure-reducing surfaces and repositioning strategies in a protocolized way. Though there is general agreement that critical care patients, including those under mechanical ventilation must use pressure-reducing surfaces, there is no enough evidence in the literature about what is the best repositioning schedule when new, high technology mattresses are used. The use of this new technology has lead to propose that repositioning can be less frequent. In the only clinical trial where this subject (time interval turning) has been addressed (Vanderwee et al, Journal of Advanced Nursing), it is concluded that a turning regimen every 4 hours is equally effective than a 2-hour turning, using this kind of mattresses. Nonetheless this study is not made in critically ill patients, that have more risk factors for developing PUs, the reason we don´t share this findings and recommendations cannot be generalized.

The study hypothesis is that in patients using APAMs, a turning regimen every 2 hour compared to a 4-hour is most effective in the prevention of PUs and could be equally safe.

The objective of this study is to investigate the effect of postural turnings every 2 hours compared to every 4 hours on the incidence of grade > II pressure ulcers (PU) in patients in ICU on mechanical ventilation (MV) ≥ 24h that use alternating-pressure air mattresses (APAMs) The study is an open label, randomized, controlled clinical trial. The main variable is the incidence of Pus grade ≥ II. As secondary variables measures of efficacy and safety of patients will be registered. The study will take place in a 26 bed medical-surgical ICU with APAMs. Randomization will be done between 24h-48h from the beginning of MV. The final analysis will be by intention to treat.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

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

  • Patients admitted to the medical-surgical ICU, requiring more than 24 hours of mechanical ventilation.
  • Patients on alternating-pressure air mattresses.
  • Patients or their legal representative able to provide written informed consent to participate in the study
  • Patients whose weight are within the limits accepted by the mattresses (45-140 Kg)
  • Over 18 years

排除标准

  • Patients with pressure ulcer at ICU admission.
  • Pregnant patients
  • Patients in which informed consent is not obtained in the first 48 hours of mechanical ventilation

结局指标

主要结局

Incidence of Pressure Ulcer (PU) Grade ≥ II

时间窗: Intensive Care Unit (ICU) length of stay (days)

Pressure ulcers were categorized according to the EPUAP-classification system. A grade I PU is non-blanchable erythema, a grade II is an abrasion or blister, a grade III is a superficial ulcer and a grade IV is a deep ulcer

次要结局

  • ICU Mortality(ICU length of stay (an average of 28 days))
  • Workload of Nurses(icu length of stay)
  • Length of Mechanical Ventilation (MV)(ICU length of stay)

研究者

发起方
University Hospital Virgen de las Nieves
申办方类型
Other
责任方
Principal Investigator
主要研究者

Francisco Manzano Manzano

MD,PhD

University Hospital Virgen de las Nieves

研究点 (2)

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