Evaluation on the Effect of Acupuncture and Neuromuscular Electrical Stimulation on Mechanical Ventilation Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- ventilator-free days at 28 days
研究概览
简要总结
Acupuncture is a treatment intervention used globally for a wide variety of disorders. Its efficacy has been established over the course of 3000 years, originating in Asia and diversifying worldwide.The scientific basis for acupuncture remains unclear. Nonetheless, acupuncture releases neurochemical substrates, such as endorphins, serotonin, and norepinephrine.Acupuncture is considered to be a safe treatment when applied by a certified acupuncturist.Acupuncture has already been deployed in the treatment of sepsis or muscle weakness.Studies have revealed that acupuncture significantly improved grip strength and respiratory muscle strength in chronic obstructive pulmonary disease participates.Neuromuscular electrical stimulation (NMES) is an alternative to mobilize and exercise because it does not require active patient participation and can be used on bedridden patients.The investigators designed a study to compare the effects of acupuncture, electroacupuncture, and neuromuscular electrical stimulation on mechanical ventilation patients with weaning difficulties
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
- Single (Outcomes Assessor)
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
- •Prolonged mechanical ventilation duration (>72 h)
- •stable oxygen saturation, fraction of inspired oxygen≤55%, and positive end expiratory pressure (PEEP)≤8 cmH2O
- •dose of dopamine<10 μg/kg/min and dose of epinephrine<0.4 μg/kg/min;
- •mean arterial pressure>75 mmHg and urine output>1 mL/kg/h
- •good healing of the incision after surgery;
- •normal cognitive function
- •no history of chronic mental illness or chronic obstructive pulmonary disease
排除标准
- •Inability to perform physical activities
- •long-term MV prior to admission
- •neurological comorbidities involving muscles
- •irreversible disorders with a 6-month mortality rate of>50% according to Acute Physiology and Chronic Health Evaluation II (APACHEII)
- •unsound limbs or unstable fractures
- •administration of glucocorticoids (prednisone or other corticosteroid dose equivalents>20 mg/day) for at least 20 days prior to admission
- •cardiopulmonary resuscitation before admission to the ICU
- •radiotherapy or chemotherapy within the previous 6 months
- •presence of comorbidities, including acute myocarditis, deep venous thrombosis/embolism, and cerebrovascular accident
- •Patients with implanted pacemakers or defibrillators
- •Pregnancy and lactation patients
- •Patients with active bleeding or bleeding tendency
- •Skin infection or injury at the acupuncture site
结局指标
主要结局
ventilator-free days at 28 days
时间窗: up to 28days
次要结局
- Diaphragmatic thickening fraction(DTF)(baseline,Day 3 of mechanical ventilation,Day 7 of mechanical ventilation,before extubation)
- Parasternal Intercostal Muscle Ultrasound(baseline,Day 3 of mechanical ventilation,Day 7 of mechanical ventilation,before extubation)
研究者
JinyanXing
Director
The Affiliated Hospital of Qingdao University