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【ChiCTR-IOR-17010484】保持ICU機械通氣危重病人四肢肌肉量

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基本信息

登记号

ChiCTR-IOR-17010484

试验状态

结束

药物名称

药物类型

规范名称

首次公示信息日的期

2017-01-19

临床申请受理号

靶点

适应症

Respiratory and cardiac

试验通俗题目

保持ICU機械通氣危重病人四肢肌肉量

试验专业题目

保持ICU機械通氣危重病人四肢肌肉量

申办单位信息

申请人联系人

申请人名称

联系人邮箱

联系人邮编

联系人通讯地址

临床试验信息

试验目的

The present study aimed to (1) examine the effect of early neuromuscular electrical stimulation (NMES) on quadriceps and biceps muscles size (in terms of thickness and cross sectional area) in patients who are mechanically ventilated in intensive care unit (ICU), and (2) elevate the quality of life and functional status of those patients receiving NMES at ICU discharge and (3) quantify the ICU length of stay, hospital length of stay and number of patients who were diagnosed with ICU acquired weakness at ICU discharge.

试验分类

试验类型

随机平行对照

试验分期

其它

随机化

Patients will be randomly assigned with one limb for NMES treatment by drawing lots and the other limb will act as a control without intervention.

盲法

试验项目经费来源

Self finance

试验范围

目标入组人数

实际入组人数

第一例入组时间

2015-10-01

试验终止时间

2017-03-31

是否属于一致性

入选标准

1. Adult patients at ICU who are on mechanical ventilator due to acute respiratory failure, trauma, sepsis, and acute coronary syndromes; 2. Cardiorespiratory stability: FiO2≤ 55% & noradrenaline ≤ 0.2 ug/kg/min.；

排除标准

1. Conditions contraindicated for NMES such as skin allergy, open wounds or superficial metal implants over stimulation sites, etc.; 2. Trauma or surgery of leg, pelvis, or lumbar spine; 3. Open abdominal wounds; 4. Extreme obesity (BMI > 35kg/m2); 5. Serious bedsore or venous ulcers; 6. Pre-existing diagnosis causing neuromuscular weakness; 7. Acute stroke, Status epilepticus; 8. Coagulation disorders (INR>1.5 or platelets < 50,000/mm3); 9. Psychiatric disorder or emotional instability; 10. Cardiorespiratory instability: - PaO2 <8.66kPa; - Minute ventilation >150mL/kg body weight; - Respiratory rate >30 BPM; - On vasopressive support (noradrenaline > 0.2μgkg-1.min-1, dobutamine > 8μg.kg-1.min-1). 11. Acute renal failure with increased serum creatinine level (normal result is 0.7 to 1.3 mg/dL for men and 0.6 to 1.1 mg/dL for women); 12. APACHE II score ≥ 30.；

研究者信息

研究负责人姓名

试验机构

香港理工大學伊麗莎白女王醫院理療科

研究负责人电话

研究负责人邮箱

研究负责人邮编

联系人通讯地址

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