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Air Suspension Biodegradable Patient Transport Pad

The Design and Application of Air Suspension Biodegradable Patient Transport Pad

On the one hand, transferring patient from bed to bed is usually handling by the manual lifting of several staffs or utilizing bedsheet, slide sheet , shovel-style stretcher or other devices to move and lift patients. Whatever, there are some advantages using these devices.

On the other hand, nurses are among the professionals at the highest risk for musculoskeletal disorders. The Bureau of Labor Statistics has shown that overexertion in manual lifting was the main event or exposure leading to injury or illness involving time away from work. Excessive weights, awkward postures, and repetitive motions are some of the known risk factors that contribute to sprains/strains and back injuries. During the process of patient transferring , it refers to the above risk factors for health-care workers. It recommended that using appropriate assistive equipment can reduce the injuries. If staff is safe, patients are safer.

The research team has designed and produced a new transport assistive devices-- biodegradable and air-suspending transfer mattress, which was precisely controlled by gas flow and based on ergonomics. And then apply it to the clinic in order to find whether it's benefit for patients and nursing staff.

It is a randomized controlled trial design.

研究概览

详细说明

Research design:randomized controlled trials. Computer generated random numbers. The patients were randomly divided into three groups, ① transfer patients by air-suspending mattress, ② transfer patients by slide board, ③ transfer patients by bedsheets.

Participants: passive patient with transports needs, such as CT/ MRI examination etc. The sample size estimation was according to the formula of multiple parallel design. The main outcome measure was the perceived exertion.

研究类型

介入性

注册 (预期的)

300

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。

学习地点

    • Zhejiang
      • Hangzhou、Zhejiang、中国、310009
        • Second Affiliated Hospital, School of Medicine, Zhejiang University

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

15年 及以上 (孩子、成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Passive patient with transfer requirements, such as CT/ MRI examination , transfer from one department to another etc;Patients or their family signed an informed consent.

Exclusion Criteria:

  • The patients weighted over 150kg and have spine fracture ;age< 15 years old.

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:Experimental group
Patients in experimental group were transferred by air-suspending mattress.
Put mattress in advance on the bed. When patients need to be transferred from bed to bed, fill the mattress with gas and keep it inflated, then pull the mattress .
有源比较器:control group 1
Patients in control group 1 were transferred by slide board.
When patients need to be transferred from bed to bed, insert slide board under patient, then pull the slide board.
有源比较器:control group 2
Patients in control group 2 were transferred by bedsheet.
When patients need to be transferred from bed to bed, just lift the bedsheet.

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
Force value
大体时间:Day 1
Spring balance was used to measured the pulling force while transferring patients.(Force value in N)
Day 1
perceived exertion
大体时间:Day 1
Perceived exertion was evaluated by using the Borg Scale of 6-20, which the values near 6 and 20 represent low and high physical exertion, respectively.(perceived exertion in scores)
Day 1

次要结果测量

结果测量
措施说明
大体时间
respiration rate
大体时间:Day 1(before and after transferring)
Be recorded by ECG monitor the moment before and after transferring.(respiration rate in bpm)
Day 1(before and after transferring)
blood pressure
大体时间:Day 1(before and after transferring)
Be recorded by ECG monitor the moment before and after transferring.(blood pressure in mmHg)
Day 1(before and after transferring)
heart rate
大体时间:Day 1(before and after transferring)
Be recorded by ECG monitor the moment before and after transferring.(heart rate in bpm)
Day 1(before and after transferring)
oxygen saturation
大体时间:Day 1(before and after transferring)
Be recorded by ECG monitor the moment before and after transferring.
Day 1(before and after transferring)
Transfer time
大体时间:Day 1
Stopwatch was used to record the time from using the assistive devices to moving the patients to another bed.(transfer time in minutes)
Day 1

其他结果措施

结果测量
措施说明
大体时间
Satisfaction of patient
大体时间:Day 1
Self-made satisfaction questionnaire was used to get the patients' satisfaction about the assistive devices after transferring patients.It includes five items about the feelings of assistive devices while moving--comfort, safety, pain, stability and sound. All the answers take five levels, level five means very satisfied and level one represents very dissatisfied.(Satisfaction of patient in scores)
Day 1
Satisfaction of nurse staff
大体时间:Day 1
Self-made satisfaction questionnaire was used to get nurse staffs' satisfaction about the assistive devices after transferring patients. It includes seven items about using the devices to move patients --no adverse events, saving energy, saving time, convenience, applicability, strong support and total satisfaction. All the answers take five levels, level five means very satisfied and level one represents very dissatisfied.(Satisfaction of patient in scores)
Day 1

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:Jingfen Jin, Master、The Second Affiliated Hospital of Medical College of Zhejiang University

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)

2018年3月28日

初级完成 (实际的)

2019年12月31日

研究完成 (预期的)

2020年6月30日

研究注册日期

首次提交

2019年2月18日

首先提交符合 QC 标准的

2019年2月26日

首次发布 (实际的)

2019年2月28日

研究记录更新

最后更新发布 (实际的)

2020年2月12日

上次提交的符合 QC 标准的更新

2020年2月11日

最后验证

2020年2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

  • 2018PY011

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

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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