Evaluation of the NeuRx RA/4 Diaphragmatic Pacemaker in Tetraplegic Patients With Spinal Cord Injuries in Ventilator Support
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Volume comparison of the basal with the tidal volume obtained with the NeuRx RA/4 pacemaker in patients with diaphragmatic paralysis
研究概览
简要总结
Permanent dependency of breathing apparatus due to spinal cord injury is traditionally treated with different types of mechanical ventilation. However, the electric ventilation became a possibility through their most current versions, such as diaphragmatic pacemakers.
Diaphragmatic pacemakers rhythmically stimulates the diaphragm to replace the functions of the respiratory center that doesn't works well or is inaccessible. However, this modality has the prerequisite that the phrenic nerve and diaphragm muscle are normal. The reason for the development of diaphragmatic pacemaker freeing the patient from the ventilator.
By using the mechanical energy of the diaphragm of the patient, the patient may come not need the ventilator tubing, tracheostomy, and with the help of their caregivers, the inconvenient mechanical ventilators.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •18 years old or more
- •Cervical spinal cord injuries patients under mechanical ventilation
- •Clinically stable after spinal cord injury
- •Clinical acceptable bilateral phrenic nerve function demonstrated with electromyography and neural conduction time
- •Fluoroscopic visible diaphragmatic movements under stimulation
- •Hemodynamically stable
- •No co-morbidities that can interfere with pacemaker implantation or function
- •Pregnancy negative test for women
- •Patient or legal representative informed consent
排除标准
- •Active pulmonary disease
- •Active cardiovascular disease
- •Active cerebral disease
- •Hemodynamic instability or low oxygen levels in ambient air
- •Hospitalization for infection in the last 3 months
- •Significant scoliosis or chest disease
- •Poor compliance to the protocol from the patient or the caregiver
结局指标
主要结局
Volume comparison of the basal with the tidal volume obtained with the NeuRx RA/4 pacemaker in patients with diaphragmatic paralysis
时间窗: One year
The ability of the NeuRx RA / 4 to obtain clinically acceptable tidal volume during a period of 4 continuous hours will be evaluated by spirometry. Clinically acceptable volume is defined as a volume in excess of 15% above the basal metabolic requirements of the particular patient. For a male patient, the flow volume to meet the basal metabolic requirement is set at 7 ml/kg body weight, while for a female patient, it is defined in 6ml/Kg body weight.
次要结局
- Functional rehabilitation by measure of total usage time, both day and night(One year)
研究者
Miguel L. Tedde
MD, PhD
University of Sao Paulo