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The Effect of Repositioning Frequency Determined According to BMI on Pressure Ulcer Development Time

2022年8月17日 更新者:Ebru Bulut、Aydin Adnan Menderes University

The Effect of Repositioning Frequency Determined According to Body Mass Index on Pressure Ulcer Development Time: Randomized Controlled Trial

The research will be carried out in an experimental/randomized controlled manner in order to determine the effect of the frequency of repositioning according to body mass index on the development of pressure ulcers in adults.

The sample size was determined as 66 people by power analysis. However, considering the losses, the number of patients included in the sample will 30% higher than the calculated value and it was planned to include 86 patients (43 intervention group, 43 control group) in the study. In the first 24 hours of hospitalization, body mass index will be calculated by skinfold thickness measurement, and data will be collected using the "Structured Questionnaire" for patients with no pressure sores, bedridden, high and very high risk according to the Braden Risk Assessment Scale. In calculating the body mass index of bedridden patients, skinfold thickness measurement, measurement of the interface pressure, which is the most important factor in the development of pressure sores, and calf circumference measurement will be performed to determine the decrease in muscle mass. The research will continue with position change applications between 08-24 hours every day of the week. Patients in the intervention group will be given 30 degrees right lateral, supine, and 30 degrees left lateral positions, 1 hour apart, respectively. Patients in the control group will be given 30 degrees right lateral, supine and 30 degrees left lateral positions, respectively, at 2 hour intervals according to the hospital routine practice. In the initial evaluation, the interface pressure will be measured with the Palm Q-Portable Interface Pressure Sensor from the occipital, scapula, sacrum, heels when the patients are in the supine position, and from the pressure points of the acromion, greater thoracantary, and malleolus prominence when they are in the 30 degrees right and 30 degrees left lateral positions. Patients will be evaluated first within the first 24 hours of hospitalization and on day 21 if a pressure ulcer develops or does not develop a pressure sore a second time.

If the study is successful, it is expected that pressure ulcers will not develop in patients who are positioned at more frequent intervals.

研究概览

地位

招聘中

条件

详细说明

Pressure sores usually occur with ischemia and cell death over bony prominences. It is one of the most common complications in bedridden patients in healthcare institutions worldwide. Its prevalence is used as a worldwide quality indicator and shows that pressure sores are a common health problem worldwide. Its incidence has been found in a wide range between 0% and 72.5% worldwide.

Pressure sores slow down the healing process, prolong the hospital stay, increase the risk of complications, and therefore adversely affect the quality of life of the patients. It increases the cost of maintenance and threatens life. Prevention of pressure sores and early diagnosis of possible tissue damage is important. For this, measures should be taken to eliminate or reduce the effects of risk factors by evaluating them correctly.

In the researches, the importance of body mass index, which plays a role in the development of pressure sores, has been determined. External pressure, which varies according to the body mass index, the physical characteristics of the patient and the characteristics of the support surface used, is the most important factor that plays a role in the development of pressure sores. Pressure sores occur due to external pressure.

The interface pressure, which occurs during the transmission of external pressure to the subcutaneous tissues between the support surface and the skin, may be different in people with different body structures. In studies, it is stated that collagen, muscle mass, adipose tissue density and body mass index around the capillaries affect the interface pressure. It is known that the density of collagen, muscle mass and adipose tissue is different in people with different body mass indexes.

It is important to keep the interface pressure low to allow the return of blood flow to prevent the formation of pressure-related wound.

For this, it is thought that by changing the frequency of repositioning, the interface pressure will prevent blood flow for a long time and tissue damage will be prevented.

研究类型

介入性

注册 (预期的)

66

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

  • 姓名:Zeynep Günes, Professor
  • 电话号码:2924 +90 256 218 00 00
  • 邮箱zgunes@adu.edu.tr

学习地点

      • Aydin、火鸡
        • 招聘中
        • Aydin Adnan Menderes University Research and Application Hospital
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Bedridden (1 and 2 points from the activity and movement subheadings of the Braden Risk Assessment Scale)
  • Pressure ulcer not yet developed
  • In the first 24 hours of hospitalization, it was evaluated according to the Braden Risk Assessment Scale and determined to be at high risk (range of 10-12 points) for the development of pressure ulcers

Exclusion Criteria:

  • With hip fracture
  • The position is not considered appropriate by the physician.
  • Connected to Mechanical Ventilator
  • Presence of septic shock
  • Albumin value ≤3.5 mg/dl

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:预防
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:İntervention group
Patients in the intervention group will be given 30 degrees right lateral, supine, and 30 degrees left lateral positions, 1 hour apart, respectively.
Patients in the intervention group will be given 30 degrees right lateral, supine, and 30 degrees left lateral positions, 1 hour apart, respectively.
无干预:Control group
Patients in the control group will be given 30 degrees right lateral, supine and 30 degrees left lateral positions, respectively, at 2 hour intervals according to the hospital routine practice.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
The rate of pressure ulcer development is changed in patients who are positioned more frequently.
大体时间:21 days
If the study is successful, it is expected that the pressure ulcer development time will be prolonged or pressure ulcer will not develop in patients who are positioned more frequently.
21 days

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Ebru Bulut, Researcher、Researcher
  • 研究主任:Zeynep Günes, Professor、Researcher

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2022年7月1日

初级完成 (预期的)

2023年1月31日

研究完成 (预期的)

2023年6月30日

研究注册日期

首次提交

2022年8月3日

首先提交符合 QC 标准的

2022年8月16日

首次发布 (实际的)

2022年8月17日

研究记录更新

最后更新发布 (实际的)

2022年8月19日

上次提交的符合 QC 标准的更新

2022年8月17日

最后验证

2022年8月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • AdnanMenderesU

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

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