A Feasibility Trial to Evaluate the Use of GraduCheck® in Enabling Experienced Tissue Viability Nurses to Achieve Ideal Sub-Bandage Pressures in Healthy Volunteers
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 12
- 主要终点
- Pressure profile
研究概览
简要总结
The purpose of this study is:
- to evaluate the feasibility of using the GraduCheck® device to optimise the compression profile attained by experienced tissue viability nurses (TVNs) using standard, commonly prescribed, multi-layer bandage systems (Actico, Coban and K2) on healthy volunteers.
- to evaluate the feasibility of using the Graducheck® device to ensure that it does not add excessive time to apply the different sorts of compression bandaging (Actico, Coban and K2) when using the GraduCheck® system to monitor the compression.
详细描述
This trial is designed to investigate the feasibility of using the GraduCheck® device to achieve optimal compression profiles under compression bandages by experienced TVNs and to check that this does not add excessive time to the bandaging.
This prospective feasibility trial compares the sub-bandage compression profiles achieved by experienced TVNs when applying compression to volunteers without any pressure feedback (hence using experience only), compared with applying compression whilst using the GraduCheck® numerical display for compression feedback during application.
This comparison will be made using three different compression systems on each volunteer. The last system used should be Urgo K2.
The three multi-layer compression bandaging systems will be:
- Actico
- Coban
- Urgo K2
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 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
- 是
入选标准
- •Adults aged 18 and over
- •Have an ankle brachial pressure index (ABPI) between 0.8-1.2 (at assessment)
- •Have no active ulceration
排除标准
- •Under the age of 18
- •Unable to wear compression bandages of hosiery for any reason
- •Unable to walk unaided and at normal speed for at least one mile
- •Previous history of deep vein thrombosis
- •Have known arterial insufficiency (an ABPI of below 0.8) (at assessment)
- •Unable to tolerate a cuff at 40 mmHg around ankle (at assessment)
- •Have active ulceration
- •Have signs of recent lower limb trauma, active infection, ongoing untreated venous disease, or significant ankle oedema
- •Unable to give informed consent
- •Fragile skin that may be damaged whilst trying to apply compression bandaging
结局指标
主要结局
Pressure profile
时间窗: 1 day
Pressure profile obtained under compression bandaging with and without GraduCheck guidance
次要结局
- Time taken to bandage with GraduCheck guidance(1 day)
研究者
Mark Whiteley
Consultant Venous Surgeon
The Whiteley Clinic