Breath Synchronized Electrical Stimulation of the Abdominal Wall Muscles to Prevent Respiratory Muscle Atrophy During the Acute Stages of Mechanical Ventilation Therapy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 6
- 主要终点
- Thickness of the abdominal wall muscles
研究概览
简要总结
Patients requiring prolonged time on the ventilator are susceptible to a wide range of clinical complications and excess mortality. It is therefore imperative for them to wean at the earliest possible time.
Respiratory muscle weakness due to disuse of these muscles is a major underlying factor for weaning failure. Surprisingly, there is not much known about the impact of critical illness and MV on the expiratory abdominal wall muscles.These muscles are immediately activated as ventilation demands increase and are important in supporting respiratory function in patients with diaphragm weakness. Weakness of expiratory abdominal wall muscles will result in a decreased cough function and reduced ventilatory capacity. These are considerable causes of weaning failure and (re)hospitalisation for respiratory complications such as pneumonia.
Recent evidence shows that neuromuscular electrical stimulation (NMES) can be used as a safe therapy to maintain skeletal muscle function in critically ill patients. This study will be the first to test the hypothesis that breath-synchronized NMES of the abdominal wall muscles can prevent expiratory muscle atrophy during the acute stages of MV.
详细描述
Approximately 30-40% of intubated patients at the intensive care unit (ICU) take more than one attempt to wean from mechanical ventilation (MV). 6-14% of intubated patients take longer than 7 days to wean from MV. Patients requiring prolonged time on the ventilator are susceptible to a wide range of clinical complications and excess mortality. It is therefore imperative for them to wean at the earliest possible time.
Respiratory muscle weakness due to disuse of these muscles is a major underlying factor for weaning failure. It is known that diaphragm strength rapidly declines within a few days after the initiation of MV. Surprisingly, there is not much known about the impact of critical illness and MV on the expiratory abdominal wall muscles.These muscles are immediately activated as ventilation demands increase and are important in supporting respiratory function in patients with diaphragm weakness. Weakness of expiratory abdominal wall muscles will result in a decreased cough function and reduced ventilatory capacity. These are considerable causes of weaning failure and (re)hospitalisation for respiratory complications such as pneumonia.
Recent evidence shows that neuromuscular electrical stimulation (NMES) can be used as a safe therapy to maintain skeletal muscle function in critically ill patients, e.g. by stimulating quadriceps muscles in patients receiving MV.
This study will be the first to test the hypothesis that exhalation synchronized NMES of the abdominal wall muscles can prevent expiratory muscle atrophy during the acute stages of MV. The investigators hypothesize that this approach will improve respiratory function and thereby will reduce the amount of time it takes to wean patients from mechanical ventilation.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age > 18 year
- •invasive mechanical ventilation less than 72 hours
- •expected duration of MV after inclusion > 72 hours
排除标准
- •no clearly visible separate layers of the abdominal wall muscles (external oblique, internal oblique and transverse abdominal muscles), assessed with ultrasound during routine care
- •cardiac pacemaker
- •congenital myopathies and/or existing central or peripheral neuropathies
- •refractory epilepsy
- •recent abdominal surgery within four weeks prior to study inclusion
- •body mass index (BMI) greater than 35 kg/m2
- •pregnancy
研究组 & 干预措施
VF03-K active stimulation
NMES applied to the abdominal wall muscles using the VentFree prototype (VF03-K). Stimulation is applied twice daily for 30 minutes, 5 days per week, for 6 weeks or until the patient is weaned from mechanical ventilation, whichever occurs sooner.
干预措施: VentFree prototype (VF03-K) active stimulation (Device)
VF03-K sham stimulation
Sham stimulation applied to the abdominal wall muscles using the VentFree prototype (VF03-K). Sham stimulation is applied twice daily for 30 minutes, 5 days per week, for 6 weeks or until the patient is weaned from mechanical ventilation, whichever occurs sooner.
干预措施: VentFree prototype (VF03-K) sham stimulation (Device)
结局指标
主要结局
Thickness of the abdominal wall muscles
时间窗: Until study completion, up to 6 weeks
Thickness of the abdominal wall muscles over time, for both groups, as measured by ultrasound.
次要结局
- Thickness of the diaphragm(Until study completion, up to 6 weeks)
- Maximum expiratory pressure (MEP)(Within 24 hours after extubation)
- Peak expiratory flow(Within 24 hours after extubation)
- Systemic inflammatory markers(Within 24 hours after extubation)
- Number of patients with respiratory complications after ICU discharge(Up to 6 weeks after ICU discharge)
- Thickness of the rectus abdominis muscle(Until study completion, up to 6 weeks)
- Maximum inspiratory pressure (MIP)(Within 24 hours after extubation)
- Vital capacity (Vc)(Within 24 hours after extubation)
- Number of patients with extubation failure(Within 24 hours after extubation)
研究者
Leo Heunks
MD, Prof
Amsterdam UMC, location VUmc