Effects of Neuromuscular Electrical Stimulation on Critically Ill Patients With Mechanical Ventilation
试验速览
- 阶段
- 不适用
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- diaphragmatic thickening fraction(DTF)
研究概览
简要总结
Up to 25% of patients who require mechanical ventilation (MV) more than seven days in the intensive care unit (ICU) develop muscle weakness, which comprises deep muscle weakness , including the respiratory muscles.Early active mobilization in ICU patients is a safe and viable strategy to prevent the physical problems caused by immobility. 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.No previous studies have shown whether training-specific respiratory muscles using an electrical stimulation can have overall benefits for ICU patients on MV.For this reason, the aim of this study was to evaluate, the effectiveness of the NMES therapy combined with early rehabilitation in the respiratory muscles of patients on MV.
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 MV(>72 h);
- •Written informed consent was obtained from the patients or their relatives
排除标准
- •Previous neuromuscular disease;
- •Unrelieved pneumothorax, restricted diaphragmatic dyskinesia including abdominal high pressure, a large number of ascites
- •Thoracic or diaphragmatic malformation;
- •Local skin damage and infection;
- •Indwelling a temporary or permanent pacemaker;
- •Severe obesity(BMI>35 kg/m2)
- •Various reasons (severe intestinal gas accumulation, structural abnormalities) lead to the failure of ultrasonic detection of diaphragm movement;
- •Patients with an expected survival time of less than 7 days or with palliative care
研究组 & 干预措施
NMSE Group
Neuromuscular Electrical Stimulation(NMES) group received consecutive daily sessions of electrical stimulation at specific points starting on the first day of randomization.The subjects also receive conventional physical therapy, which included gross motor therapy and respiratory therapy twice a day every day during their stay in the ICU.
干预措施: Neuromuscular Electrical Stimulation (Behavioral)
CPT group
The subjects only receive conventional physical therapy, which included gross motor therapy and respiratory therapy twice a day every day during their stay in the ICU.
结局指标
主要结局
diaphragmatic thickening fraction(DTF)
时间窗: baseline,Day 3 of mechanical ventilation,Day 7 of mechanical ventilation,before extubation
DTF shows varied thickness of the diaphragm at end-expiration and end-inspiration. Te maximum and minimum values of each breathing cycle were taken as the end-inspiratory diaphragm thickness (DTei) and the end-expiratory diaphragm thickness (DTee), respectively. DTF was calculated by DTF=(DTei DTee)/DTee 100%. Te values for 3 consecutive respiratory cycles were recorded and the average value was taken as the fnal value
次要结局
- 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