NCT02425917撤回不适用
Comparison of Intermittent Pneumatic Compression (IPC) of the Calf and gekoTM Neuromuscular Electrostimulation (NMES) Device on Lower Limb Circulation Following Elective Total Hip Replacement (THR)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Ultra sound measurements of haemodynamics
研究概览
简要总结
This study is designed to compare the effect of IPC on post-operative circulation in lower limbs with gekoTM device after total hip replacement procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and Female
- •Aged over 18-80 years
- •Be in good general health and fitness other than the clinical requirement for a planned hip replacement.
- •Free of significant abnormal findings as determined by medical history (specifically an absence of DVT or haematological disorders.
- •No history or signs of drug abuse (including alcohol), licit or illicit.
- •Has not used any medications (prescribed or over-the-counter including herbal remedies) judged to be significant by the Principal Investigator (PI) during the thirty (30) days preceding the study.
- •Able to understand the Patient Information Sheet and willing to sign the written Informed Consent Form.
- •Able and willing to follow the protocol requirements.
排除标准
- •Are requiring hip revision surgery
- •History or signs of significant haematological disorders (especially in relation to clotting or coagulation or previous deep or superficial vein thrombosis/pulmonary embolism).
- •Significant Peripheral arterial disease (ABPI < 0.8), 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).
- •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 ix. Haematological conditions i.e. coagulation disorders, sickle cell disease
- •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.
- •Any significant illness during the four (4) weeks preceding the hip replacement surgery.
- •Participation in any clinical study during the eight (8) weeks preceding the screening period
研究组 & 干预措施
geko
Experimental
干预措施: geko (Device)
ipc-calf
Active Comparator
intermittent pneumatic compression of the calf
干预措施: IPC-Calf (Device)
结局指标
主要结局
Ultra sound measurements of haemodynamics
时间窗: 10mins
次要结局
- Adverse event rate(3 hrs)
- patient rated tolerability(3 hrs)
研究者
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