Application of Vibration Therapy as a Measure of Muscle Activation in ICU Patients and Its Effect on Hemodynamics, Intracranial Pressure as Well as Energy Metabolism
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change of vital parameters as a measure of hemodynamic stability to show safety and tolerability
研究概览
简要总结
Vibration therapy is used for different indications in rehabilitation and sports medicine. So far, vibration therapy has not been investigated within the ICU setting. The investigators created this setting to show safety and applicability of vibration therapy in ICU patients. 30 patients will be stimulated by vibration therapy on two separate days during their ICU stay. Three collectives of equal size will be observed: One with patients on mechanical ventilation without signs of infection or suspected intracranial pressure problems, a second one with patients on mechanical ventilation in addition to signs of systemic inflammation but absence of suspected intracranial pressure problems, and a third one with patients on mechanical ventilation, signs of systemic inflammation in addition to presence of controlled intracranial pressure problems. Typical parameters of hemodynamic status, intracranial pressure and energy metabolism will be recorded for a defined period of time before, during and after vibration therapy itself. Vibration therapy will be combined with protocol based physiotherapy.
Our aim is to show the effects of vibration therapy in ICU patients and its safe applicability.
ADDITION 06th of May 2011: Additionally we will perform euglycaemic hyperinsulinemic clamp and intervention on one day of ICU stay in 20 patients. Under clamp conditions we will perform a vibration therapy (ProMedVi Vibrosphere™) on patients' legs. On top we will perform electrical muscle stimulation (schwa-medico, MUSKELaktiv™) on one ventral upper leg, randomized chosen. Measuring the local skeletal muscle metabolism will be done by microdialysis in Vastus lateralis on both sides - comparing vibration therapy and vibration therapy combined with electrical muscle stimulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- 否
入选标准
- •immobilized icu patients:
- •with mechanical ventilation without signs of infection
- •with mechanical ventilation and SIRS or sepsis
- •with mechanical ventilation, with controlled elevated intracranial pressure and with or without SIRS or sepsis
- •signed declaration of consent by the patient or its legal proxy
排除标准
- •age < 18 years old
- •already known neuromuscular disease
- •missing declaration of consent by the patient or its legal proxy
- •implanted heart pacemaker or defibrillator
- •pregnancy
- •acute thrombosis
- •not yet healed fracture ad the part of the body which will be trained
- •implants ad the part of the body which will be trained
- •a nearly done ophthalmic surgery
- •acute disc prolapse
- •infaust prognosis, that means death is expected into the next couple of hours, although maximum therapy is done
结局指标
主要结局
Change of vital parameters as a measure of hemodynamic stability to show safety and tolerability
时间窗: Continuous record for 90 minutes - within 4 blood samples - vibration therapy compared to baseline
Changes in heart rate, arterial blood pressure, saturation of peripheral pulse oximetry, intracranial pressure, mechanical ventilation parameters, electrolytes, blood sugar and lactate levels, blood pH, PICCO-parameters, body temperature as well as pO2 und pCO2 partial pressure.
次要结局
- Change of vital parameters as a measure of hemodynamic stability to show safety and tolerability.(Continuous record for 90 minutes - within 4 blood samples - vibration therapy compared to baseline)
- Change in systemic and local energy metabolism as measure of muscle activation by vibration therapy and electrical muscle stimulation(Continuous record for app. 10 hours - therapy compared to baseline)
- Change in peripheral energy metabolism and hormonal state as a measure of muscle activation and systemic inflammatory reaction induced by vibration therapy.(Continuous record for 90 minutes - within 4 blood samples - vibration therapy compared to baseline)
- Change in peripheral energy metabolism and hormonal state as measure of muscle activation and systemic inflammatory reaction induced by vibration therapy(Continuous record for 90 minutes - within 4 blood samples - vibration therapy compared to baseline)
研究者
Steffen Weber-Carstens
Dr. med. Steffen Weber-Carstens, Dept. of Anesthesiology and Intensive Care Medicine, Charite University, Berlin, Germany.
Charite University, Berlin, Germany