Effects of Physical Therapy With Neuromuscular Electrical Stimulation in Critically Ill Patients: a Randomised Crossover Clinical Trial Protocol.
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Change of Oxygen consumption (VO2),from baseline and interventions.
研究概览
简要总结
The study will investigate the effects of neuromuscular electrical stimulation (NMES) in critically ill patients. The objective of this study will be investigate the effects of neuromuscular electrical stimulation (NMES) in critically ill patients.
详细描述
The study will investigate the effects of neuromuscular electrical stimulation (NMES) in critically ill patients. It will be a randomised crossover clinical trial. Thirty-one patients will enrolled. Patients will be selected, randomly, to the intervention Protocol (decubitus position with the limbs raised and NMES) and control (decubitus position with the limbs raised without NMES).The patients will be allocated in Group 1 (intervention and control) or group 2 (control and intervention) with a wash-out period of 4 to 6 hours between them.
The main outcome will be metabolic data. Linear mixed model will be used for analysis of dependent variables and estimated values of the mean of the differences of each effect.
The results of this study will allow better understanding of the metabolic effects of NMES in patients critically ill.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients that will be admitted to the intensive care unit
- •Hemodynamic stability
- •Mechanical ventilation.
排除标准
- •In general:
- •a. Pregnant women
- •b. Brain death
- •c. Neuromuscular diseases
- •d. Use of pre-existing neuromuscular blocker in the last 24 hours, prior to the study protocol.
- •Contraindications for the use of NMES:
- •a. Fractures
- •c. Skin lesions
- •d. Systemic vascular impairment diseases such as systemic lupus erythematosus, thromboembolic disease, deep vein thrombosis (which was not therapeutically anticoagulated for a time greater than 36 hours)
- •e. Lower limb amputations
- •f. Cardiac pacemaker,
- •g. Thrombocytopenia less than 20,000/mm3
- •h. BMI greater than 35 kg/m2
- •i. Important lower extremity oedema
- •j. Agitation and/or signs of pain during the electrical stimulation.
- •Contraindications to begin or continue NMES procedure:
- •a. Mean arterial blood pressure less than 65 mmHg
- •b. Use of vasopressor >50% of themaximum dose (dopamine >12.5 μg/kg per minute; vasopressin >0.02U/min and norepinephrine >1 μg/kg per minute),
- •c. Heart rate <50 or >140bpm
- •d. Arrhythmias with hemodynamic consequences
- •e. Myocardial ischemia,
- •f. Temperature <34 or >39oC
- •g. Intracranial pressure >20 cmH2O
- •h. Decrease in 10% of SpO2 baseline value or <88% for more than one minute.
结局指标
主要结局
Change of Oxygen consumption (VO2),from baseline and interventions.
时间窗: VO2 will be taken during the each intervention, it will be taken only the first day
Change of Oxygen consumption (VO2) will be evaluated by calorimetry
次要结局
- Change of Carbon dioxide production (VCO2) from baseline and interventions.(VCO2 will be taken during the each intervention, it will be taken only the first day)
研究者
Ada Clarice Gastaldi
Principal Investigator
University of Sao Paulo