Prospective, Single-center, Randomized Clinical Study to Investigate the Safety and Performance of Diaphragm Stimulation Coupled With Mechanical Ventilation
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Stimulation
研究概览
简要总结
This study is a randomized prospective, single-center feasibility study of the use and benefits of NeuRx DPS in patients undergoing tracheostomy for failure to wean.
详细描述
15 patients undergoing tracheostomy for failure to wean will be randomized into one of 3 cohorts (5 in each cohort): Cohort A: tracheostomy with no intervention; Cohort B: tracheostomy with DPS implantation and immediate stimulation and monitoring and Cohort C: tracheostomy with DPS implantation with monitoring followed with stimulation on day 5.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (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
- •Patient is intubated, on mechanical ventilation, undergoing tracheostomy, and expected to undergo mechanical ventilation for at least 5 days
- •Signed written informed consent has been obtained prior to performing any study related procedure(s)
- •Subject is at least 18 years of age
- •Negative pregnancy test if the patient is a female of child-bearing potential. (Females of child-bearing potential exclude women who are post-hysterectomy or post-menopausal.)
排除标准
- •Diaphragm malformation which makes electrode insertion impossible
- •Presence of an implantable cardioverter-defibrillator
- •Severe chronic obstructive pulmonary disease (COPD)
- •Subject is pregnant or breastfeeding
- •Diagnosis of neuromuscular disease or high level spinal cord injury prior to tracheostomy
- •Terminal patients expected to die during their stay in the hospital
- •Participation in other clinical studies that could interfere with the results in the ongoing study
结局指标
主要结局
Stimulation
时间窗: Through study completion, an average of 6 years
Increase in magnitude of diaphragm burst activity with stimulation
Device and procedure safety
时间窗: Through study completion, an average of 6 years
Device or procedure-related adverse events from time of implant until removal of electrodes prior to discharge from the hospital or 30 days, whichever occurs first
Monitoring
时间窗: Through study completion, an average of 6 years
Detection of rhythmic diaphragm burst activity for identifying the level of diaphragm dysfunction
次要结局
- Effects of diaphragm stimulation(Through study completion, an average of 6 years)