The Effect of Neuromuscular Stimulation on Post-Transplant Leg Edema
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Decrease in edema
研究概览
简要总结
This will be a randomized, controlled trial involving kidney and kidney pancreas transplant patients. There will be 2 groups and patients that will be randomized to one of the two groups. Clinical outcomes will be compared for those in each group and clinical differences between patients who receive routine medical therapy with IPC/TEDS versus the Geko device will also be evaluated.
详细描述
This will be a randomized, controlled trial involving kidney and kidney pancreas transplant patients. There will be 2 groups and patients will be randomized to one of the two; one will receive standard of care IPC or TED stockings to help with circulation, the other group will use the geko device which is a newer device with Health Canada approval. Clinical outcomes will be compared for those in each group and clinical differences between patients who receive routine medical therapy with IPC/TEDS versus the Geko device will also be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •At least 18 years old
- •Undergoing kidney or kidney pancreas transplant surgery as the recipient
- •Able and willing to provide written informed consent
- •Absence of known peripheral vascular disease
- •Body Mass Index of between 18 and 34
- •Leg circumference at site of geko™ device placement is 24" or less
排除标准
- •History of deep vein thrombosis
- •Temporary or permanent cardiac pacing
- •Patient is pregnant
- •Any patient which may be excluded by way of warnings in the Manufacturer's Instructions for Use
- •Any patient who requires an ECG electrode applied on the leg for continuous monitoring throughout therapy
- •Previous leg(s) amputation
- •Presence of any of the following in the site of intended device placement: cancerous lesion, swollen or infected or inflamed areas or skin eruptions i.e. phlebitis, thrombophlebitis, varicose veins
- •History or signs of haematological disorders (especially in relation to clotting or coagulation disorders) including presence or history of thrombus formation
- •BMI index >36
- •Patients with any neurological disorder or disease that would interfere with proper assessment and or conduct of the trial
- •History of implantable brain or other stimulator
- •Patients who can not tolerate the stimulation from the GEKO device
研究组 & 干预措施
Best Medical Therapy
Participants will follow standard post-transplant protocols with IPC
Geko device
Participants will be fitted with the device to ensure that it functions according to the manufacturer's instructions by a trained technician. This device will be changed every 24 hours. The device is worn on both legs and is worn for 24 hours a day. The device will first be put on the first day following the day of surgery and will then be changed the following day at the same time for a total of 7 days after surgery.
干预措施: Geko device (Device)
结局指标
主要结局
Decrease in edema
时间窗: Within 30 days post-transplant
As measured by patient weight and leg diameter
次要结局
- Patient satisfaction(3 and 6 days after transplant)