Feasibility Study Using Abdominal Functional Electrical Stimulation (AFES) to Assist Ventilator Weaning in Tetraplegia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Time to wean from mechanical ventilation
研究概览
简要总结
Compromised respiratory function as a result of tetraplegia leads to many tetraplegics requiring mechanical ventilation during the acute phase of injury. Mechanical ventilation is associated with additional costs to the local health care provider and reduced quality of life of the patient. Electrical stimulation of the abdominal muscles has previously been used to improve the respiratory function of tetraplegic patients in the chronic stage of injury. In this study the investigators aim to evaluate whether electrical stimulation of the abdominal muscles can assist the process of weaning from mechanical ventilation in acute ventilator dependent spinal cord injured patients.
详细描述
Purpose:
The principal aim of this study is to evaluate the feasibility of using Abdominal Functional Electrical Stimulation (AFES) to assist weaning from mechanical ventilator in acute ventilator dependent tetraplegic subjects.
Participants:
10 ventilator dependent tetraplegic participants in the acute stage of injury will be recruited while inpatients at the Queen Elizabeth National Spinal Injuries Unit (QENSIU), Southern General Hospital, Glasgow. The participants will be matched for injury level, age (+/5 years) and sex with a control obtained from historic records of previous patients in the QENSIU.
Experimental Procedures:
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute spinal cord injured tetraplegic patients (patients with a new spinal cord injury) who are inpatients at the Queen Elizabeth National Spinal Injuries Unit (QENSIU), Southern General Hospital, Glasgow;
- •Reduced respiratory function requiring mechanical ventilation;
- •Good visual response to surface abdominal stimulation, suggesting that lower motor neurons are intact.
排除标准
- •Female subjects who are pregnant;
- •Significant history of autonomic dysreflexia;
- •No visual response to surface abdominal stimulation, suggesting that lower motor neurons are not intact.
结局指标
主要结局
Time to wean from mechanical ventilation
时间窗: Assessed once per patient
Time from initial ventilation to achieve 7 days of ventilator free breathing.
次要结局
- Unassisted breathing vital capacity(Up to 8 weeks)
- AFES assisted breathing tidal volume(Up to 8 weeks)
- Unassisted breathing tidal volume(Up to 8 weeks)
- AFES assisted breathing vital capacity(Up to 8 weeks)
研究者
Henrik Gollee
Senior Lecturer
University of Glasgow