Neuromuscular Electrical Stimulation in the Critically Ill
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Duration of respiratory support
研究概览
简要总结
Neuromuscular stimulation (NMES) has been used for several years in the rehabilitation of COPD (chronic obstructive pulmonary disease) patients (among others) to improve their resistance to efforts in everyday life. In patients in intensive care, it seems to improve strength, reduce the loss of muscle mass, prevent the development of CIP / CIM (Critical illness polyneuropathy / critical illness myopathy) and perhaps even reduce ventilation days, with expected effects on the duration of hospitalization and the long-term functional outcome. Although its use could sometimes be limited by the development of peripheral edema and use of vasoconstrictors, the main advantage of this technique is the possibility of being used very early, even in patients that require deep sedation . This is extremely important given that the muscular atrophy process already starts 18h after the onset of invasive ventilation and as signs of impaired nerve transmission are developed in one third of patients at risk within 72 hours.
The purpose of the study is to assess the effects, in the short and medium term, of early neuromuscular stimulation in patients who are at higher risk of developing a critical illness polyneuropathy (CIP) / critical illness myopathy (CIM) spectrum disease.
This is a randomized controlled single-blind study comparing a group of patients submitted to NMES early (up to 5 days after admission) versus a control group unstimulated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
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
- •Admission in the ICU of the Brugmann Hospital (Unit 1020) with an intended ICU stay superior to 3 days
- •Aged over 18 years
- •Respiratory assistance needed (invasive and non-invasive ventilation, CPAP or Optiflow and PaO2(arterial oxygen pressure)/FiO2(fraction of inhaled oxygen)<200mmHg)
- •SAPSII (Simplified Acute Physiology Score) between entre 35 et 70.
排除标准
- •Definitive exclusion criteria:
- •patients bearing a pacemaker or an AICD (automatic implantable cardioverter/defibrillator )
- •BMI superior to 35
- •serious neuromuscular pathologies or alterations in the inferior members that make both tights stimulation impossible
- •pregnant women
- •patients admitted from Friday evening to Sunday morning
- •Temporary exclusion criteria:
- •Hemodynamic instability (even with filling up and amines: noradrenaline > 0.5y/kg/min and/or dobutamine >5y/kg/min and/or adrenaline ivc)
- •Extreme severity with suspicion of death within the first 24 h
- •PIC > 20 cmH2O
- •Severe agitation (RASS > +1)
- •Curare utilisation within the last 24h
结局指标
主要结局
Duration of respiratory support
时间窗: Patients will be followed for the duration of their intensive care unit stay.The average duration of an intensive care unit stay in the CHU Brugamnn Hospital in 2014, all pathologies mixed, is 6 days.
The duration of ventilatory support is defined as the time in days, during which the patient requires invasive media type (continuous or not, intubation or tracheotomy and need the help of the respirator) or noninvasive (discontinuous or CPAP NIV (continuous positive airway pressure, noninvasive ventilation)- dependence). This will be assessed during the entire length of stay of the patient inside the intensive care unit (ICU).
Length of stay in the intensive care unit
时间窗: Patients will be followed for the duration of their intensive care unit stay.The average duration of an intensive care unit stay in the CHU Brugamnn Hospital in 2014, all pathologies mixed, is 6 days.
Measured in days
Type of hospital discharge
时间窗: At hospital discharge, within a maximum of two years (approximate study length).
Back to home or to a specialized long term care structure
次要结局
- cross-sectional area of the rectus femoris(The day the patient is discharged from the intensive care unit. The average duration of an intensive care unit stay in the CHU Brugamnn Hospital in 2014, all pathologies mixed, is 6 days.)
- Physical Function ICU Test score (PFIT-s)(the day the patient is discharged from the intensive care unit. The average duration of an intensive care unit stay in the CHU Brugamnn Hospital in 2014, all pathologies mixed, is 6 days.)
- Electromyogram(The day the patient is discharged from the intensive care unit. The average duration of an intensive care unit stay in the CHU Brugamnn Hospital in 2014, all pathologies mixed, is 6 days.)
- Force index - Grip test(The day the patient is discharged from the intensive care unit. The average duration of an intensive care unit stay in the CHU Brugamnn Hospital in 2014, all pathologies mixed, is 6 days.)
- Six minutes Walking Test(one year after the day of admission to the intensive care unit)
- MOS SF-36(one year after the day of admission to the intensive care unit)
- Force index - Bike(The day the patient is discharged from the intensive care unit. The average duration of an intensive care unit stay in the CHU Brugamnn Hospital in 2014, all pathologies mixed, is 6 days.)
研究者
Jacques DEVRIENDT
Head of clinic
Brugmann University Hospital