Multi-Center Pivotal Study of NeuRx RA/4 Ventilatory Assist Device
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 10
- 主要终点
- Enrolled Subjects Achieve Clinically Acceptable Tidal Volume Sustained Over a Continuous 4 Hour Period.
研究概览
简要总结
OBJECTIVES:
The objectives of this study are to test the Diaphragm Pacing Stimulation (DPS) System for treating chronic ventilatory insufficiency in persons with respiratory muscle paralysis. The hypothesis being tested in the clinical trial is that laparoscopic stimulation of the diaphragm at the motor point with intramuscular electrodes is safe and effective in providing significant ventilatory support to individuals who are otherwise dependant on a mechanical ventilator. Patients in our initial study group have all suffered from high-level spinal cord injury and were full-time dependant on positive pressure mechanical ventilation prior to inclusion.
详细描述
System: NeuRx RA/4 Diaphragm Pacing Stimulation System
Summary:
The NeuRx-RA/4 is intended to be used by individuals that have sustained a spinal cord injury, requiring aid with respiration. The device connects to the diaphragm which delivers current to stimulate muscle contractions to aid in respirations.
This device currently holds an Investigational Device Exemption No. G920162 in the United States and is currently undergoing clinical trials at University Hospitals (Cleveland), Shepherd Center (Atlanta) and Vancouver (Canada).
Introduction:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Age 18 years or older
- •Cervical spinal cord injury dependent on mechanical ventilation
- •Clinically stable following acute spinal cord injury
- •Bilateral phrenic nerve function clinically acceptable as demonstrated with EMG recordings and nerve conduction times
- •Diaphragm movement with stimulation visible under fluoroscopy
- •Clinically acceptable oxygenation on room air (>90%)
- •Hemodynamically stable
- •No medical co-morbidities that would interfere with the proper placement or function of the device
- •Committed primary caregiver
- •Negative pregnancy test in females of child-bearing potential
- •Informed consent from patient or designated representative
排除标准
- •Co-morbid medical conditions that preclude surgery
- •Active lung disease (obstructive, restrictive or membrane diseases)
- •Active cardiovascular disease
- •Active brain disease
- •Hemodynamic instability or low oxygen levels on room air
- •Hospitalization for or a treated active infection within the last 3 months
- •Significant scoliosis or chest deformity
- •Marked obesity
- •Anticipated poor compliance with protocol by either patient or primary caregiver
- •Currently breastfeeding
结局指标
主要结局
Enrolled Subjects Achieve Clinically Acceptable Tidal Volume Sustained Over a Continuous 4 Hour Period.
时间窗: Within one year after implantation
Number of enrolled subjects that successfully maintained clinically acceptable tidal volumes greater than basal requirements over a continuous 4 hour period.
次要结局
- Number of Patients That Use NeuRx DPS to Breathe Without the Assistance of a Mechanical Ventilator for 24 Continuous Hours a Day(Within one year of implantation)
- Achieve Clinically Acceptable Basal Metabolic Requirement of Tidal Volume Measured in ml During Chronic Stimulation.(Within one year after implantation)