Breath Synchronized Abdominal Muscle Stimulation to Facilitate Ventilator Weaning: a Pilot
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Change in Maximum Inspiratory Pressure From Baseline to Extubation
研究概览
简要总结
The primary objective of this study is to determine whether neuromuscular electrical stimulation applied to the abdominal wall muscles in synchrony with exhalation can increase the strength of the respiratory muscles in prolonged mechanical ventilation patients.
详细描述
In the U.S. over 500,000 patients have difficulty weaning from mechanical ventilation every year. These patients cost the health care system $16 billion annually and have an increased risk of medical complications and morbidity.
A major factor responsible for weaning failure is the imbalance between decreased respiratory muscle strength and excessive respiratory load. This study includes an investigational device that applies electrical stimulation to the abdominal muscles in synchrony with exhalation. This is hypothesized to improve the strength of the respiratory muscles. The long term goal of this project is to determine whether this approach can reduce the number of days taken for patients to wean 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
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
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
- •Patients who have been mechanically ventilated for at least fourteen days.
- •Clinically stable: oxygen saturation > 90% with a fractional inspired oxygen ≤ 0.40, external positive end expiratory pressure ≤ 5 centimeters water, temperature ranging from 35.5 to 38.5 degrees celsius, no intravenous administration of vasoactive agents.
排除标准
- •Patients in whom Neuromuscular Electrical Stimulation (NMES) does not elicit a palpable contraction of the abdominal muscles.
- •Patients with broken or irritated skin on the abdominal wall
- •Patients with a history of neuromuscular disease
- •Body Mass Index (BMI) > 35 kg/m2
- •Patients who are not medically stable
- •Patients with a pacemaker
- •Female patients who are pregnant
- •Patients under the age of 18
- •Patients who are expected to die within four weeks
- •Patients who are unable to follow verbal instructions
- •Patients with epilepsy
- •Patients with an abdominal wall hernia
- •Patients with anoxic encephalopathy
- •Patients with history of, or active, substance abuse
结局指标
主要结局
Change in Maximum Inspiratory Pressure From Baseline to Extubation
时间窗: Change from baseline to first extubation, an expected average of 4 weeks
Maximum inspiratory pressure was measured from end expiratory lung volume.
Change in Maximum Expiratory Pressure From Baseline to Extubation
时间窗: Change from baseline to first extubation, an expected average of 4 weeks
Maximum expiratory pressure was measured from total lung capacity
次要结局
- Thickness of the Rectus Abdominis Muscle(Change from baseline to first extubation, an expected average of 4 weeks)
- Number of Days Taken to Wean(The earlier of 6 weeks or first extubation, an expected average of 4 weeks)
- Thickness of the Diaphragm(Change from baseline to first extubation, an expected average of 4 weeks)
- Weaning Success(The earlier of 6 weeks or first extubation, an expected average of 4 weeks)
- Change in Cough Peak Flow From Baseline to Extubation(Change from baseline to first extubation, an expected average of 4 weeks)
- Change in Spontaneous Respiratory Rate From Baseline to Final Study Visit(Change from baseline to final study visit, an expected average of 4 weeks)
- Change in Thickness of the Transverse Abdominis Muscle From Baseline to Extubation(Change from baseline to first extubation, an expected average of 4 weeks)
- Change in Thickness of the External Oblique Muscle From Baseline to Extubation(Change from baseline to first extubation, an expected average of 4 weeks)
- Change in Thickness of the Internal Oblique Muscle From Baseline to Extubation(Change from baseline to first extubation, an expected average of 4 weeks)
- Change in Spontaneous Tidal Volume From Baseline to Final Visit or First Extubation(Change from baseline to final study visit or first extubation, an expected average of 4 weeks)
- Change in Spontaneous Minute Ventilation From Baseline to Final Study Visit(Change from baseline to final study visit, an expected average of 4 weeks)
- Number of Adverse Events That Are Related to Treatment(Though study completion, an expected average of 4 weeks)
- Maximum Sensation of Stimulation Experienced by Patient(Through study completion, an expected average of 4 weeks)