Electronic Neuromuscular Stimulation Versus Intermittent pneumAtic Compression Devices for the pRevention of Venous Thromboembolic Disease in Critically Ill Adults: a Randomised Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Successful application of the intervention
研究概览
简要总结
In this prospective, randomised, open-label, parallel group, feasibility trial; the investigators will objectively assess whether it is feasible to apply the Geko device to critically ill adults for the prevention of venous thromboembolism (VTE) compared to usual care with intermittent pneumatic compression devices (IPCs).
详细描述
VTE is a common problem amongst patients in critical care. Current measures include intermittent pneumatic compression devices, used to aid the venous return of blood from the lower limbs. These devices are contraindicated and/or poorly tolerated by some patients. Neuromuscular stimulation of the lower leg muscles might offer a better tolerated and more physiological alternative to IPCs.
In this feasibility trial the investigators will randomly allocate 40 patients to receive either the Geko device (n=20) or IPCs (n=20) as principal means of mechanical VTE prophylaxis.
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
- 否
入选标准
- •Male or female aged ≥ 18 years.
- •Intact healthy skin at the proposed site of gekoTM device application.
- •Within 24 hours of their admission to critical care
- •Expected to remain in critical care until the day after tomorrow
排除标准
- •Use of any concurrent neuro-modulation drug or device (e.g. neuromuscular blocking agents).
- •Trauma to the lower limbs that would prevent geko™ from stimulating the common peroneal nerve.
- •Inability to palpate the fibula head in order to apply geko device effectively
- •Inability to obtain valid written consent from the participant or their designated legal representative
研究组 & 干预措施
Intervention arm
Application of the Geko device for mechanical VTE prophylaxis up until day 10 / discharge form critical care (whichever comes sooner).
干预措施: Geko device (Device)
Usual care arm
Application of our usual intermittent pneumatic compression devices for mechanical VTE prophylaxis up until day 10 / discharge form critical care (whichever comes sooner).
干预措施: Flowtron DVT (Device)
结局指标
主要结局
Successful application of the intervention
时间窗: Daily measurements up to day 10 after enrolment
Objective measures of feasibility will include successful application of the intervention device. Investigators will make a daily assessment of whether the device is successfully applied to a participant or not. Successful application is defined as a device applied and producing a visible muscle twitch in the participant's lower leg. A predefined threshold of 70% or above would indicate feasibility of effective application of the intervention to trial participants.
次要结局
- Venous return in the lower limbs(Baseline & day 3-5.)