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临床试验/NCT03317145
NCT03317145已完成不适用

Intermittent Pneumatic Compression (IPC) of the Foot Versus Geko™ Neuromuscular Electrostimulation (NMES): Comparison of Lower Limb Circulation Following Elective Total Hip Replacement (THR)

Hampshire Hospitals NHS Foundation Trust0 个研究点目标入组 10 人开始时间: 2013年7月24日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
10
主要终点
Venous flow at baseline

研究概览

简要总结

The aim of this pilot study was to assess venous flow parameters in patients following total hip arthroplasty, comparing an intermittent pneumatic compression foot device with a portable neuromuscular electrostimulator device. Assessments were performed in a single sitting before hospital discharge, between days 1 to 4 post operatively. The total duration of participation for each patient who completed the study was approximately 2.5 hours.

详细描述

Ethical approval was obtained from the National Research Ethics Service (Edgbaston), reference 13/WM/0139. Upon admission to hospital for THA, eligible patients were invited to participate in the study. Inclusion criteria were: patients undergoing primary THA, in good general health and fitness, age 18 years or over and the ability to provide written informed consent. Patients were taken to the ultrasound suite within the first three days following surgery.

Baseline ultrasound Patients lay in bed, the back supported at approximately 45 degrees, legs lying horizontal with their knees extended. Duplex ultrasound was then performed on the superficial femoral vein (Acuson S2000, Siemens). Baseline bilateral venous assessments of peak velocity, mean velocity, volume flow and vessel diameter were taken in triplicate. All scans were performed by the same ultrasonographer for consistency. Gate size was adjusted to just within the vessel wall.

Randomisation Following baseline measurements, patients were fitted with either the NMES device or an IPC device, the order determined by randomisation using online software. A representative from the study sponsor provided sealed envelopes containing the arm to be randomised which was opened on the day of testing.

Patients were randomised into arm A (NMES first, IPC second) or arm B (IPC first, NMES second). Blinding was not possible because the obvious physical differences between the two devices. Following testing of the first device, a 30-minute rest period was then given. The second device was then tested. All devices were fitted by the first author. All patients underwent scanning by the same sonographer to ensure consistency in data recording.

NMES application The NMES device (Geko T-1, Firstkind Ltd., High Wycombe, United Kingdom) was applied to both legs as per the manufacturer's instructions. The skin over the fibula head was prepared with an exfoliation pad, followed by an alcohol wipe. The device was applied to the skin using an adhesive strip and positioned so that the built-in electrodes were positioned over the common peroneal nerve. An overlay strip was then used to improve skin contact. A charge balanced short single pulse with a current of 27mA was delivered at a frequency of once per second. The pulse width adjustment has seven selectable stimulation settings ranging from 70 - 560 μs and was increased until a visible foot twitch was produced. Following successful application of the device for ten minutes, venous blood flow measurements were repeated.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
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

入选标准

  • patients undergoing primary THA,
  • in good general health and fitness,
  • age 18 years or over
  • able to provide written informed consent.

排除标准

  • Are requiring hip revision surgery
  • Previous or current diagnosis of deep vein thrombosis (DVT) or pulmonary embolism (PE).
  • History or signs of significant haematological disorders (especially in relation to clotting or coagulation) or thrombophlebitis.
  • Peripheral arterial disease, clinically significant varicose veins or lower limb ulceration or ischemia.
  • Recent surgery within the last 3 months (such as abdominal, gynaecological, hip or knee replacement).
  • Recent trauma to lower limb.
  • Chronic Obesity (BMI Index >40kg/m2).
  • Pregnancy.
  • Significant history of following diseases i. Cardiovascular: Recent MI (< 6 months) ii. Percutaneous Coronary Intervention (PCI) with stent (< 3 months for Bare metal stent (BMS) and < 12 months for Drug Eluding Stent (DES) iii. Moderate to severe CCF, uncontrolled AF iv. Neurological: Stroke, Hemiplegia/Paraplegia, Myopathies v. Renal: Moderate to severely impaired renal function vi. Hepatic: Moderate to severely impaired hepatic function vii. Psychiatric disorders viii. Dermatological conditions affecting lower limbs
  • On LMWH/Heparin (Prophylactic/therapeutic doses) or Warfarin or warfarin stopped recently and replaced by LMWH/ Heparin
  • Long term steroid use with dermatological changes
  • A pulse rate of less than 40 beats/minute
  • A sitting systolic blood pressure >180 and <100 mmHg and/or a sitting diastolic pressure of >100 mmHg.
  • Participation in any clinical study during the eight (8) weeks preceding the screening period
  • THR done for hip fracture

结局指标

主要结局

Venous flow at baseline

时间窗: "t0" - 30 minutes to include the ultrasound assessment, performed between days 1 and 4 post operatively

Measured within the superficial femoral vein using ultrasound

Venous flow after application of device 2

时间窗: "t2" - 150 minutes to include the ultrasound assessment

Measured within the superficial femoral vein using ultrasound

Venous flow after application of device 1

时间窗: "t1" - 90 minutes to include the ultrasound assessment

Measured within the superficial femoral vein using ultrasound

次要结局

  • Patient satisfaction with device 1(Immediately after completion of the ultrasound assessment for device 1, at "t1" - 90 minutes)
  • Patient satisfaction with device 2(Immediately after completion of the ultrasound assessment for device 2, at "t2" - 150 minutes)

研究者

申办方类型
Other
责任方
Sponsor

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