Prospective, Single-centre, Open-label Clinical Study to Investigate the Safety and Performance of the NeuRx Diaphragm Pacing System (DPS) in Patients Undergoing Bilateral Lung Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Tolerability: Patient withdrawal from treatment.
研究概览
简要总结
This study is a prospective, single-center feasibility study to acquire more knowledge regarding the NeuRx DPS and develop a routine in the optimal pacing of the diaphragm with this system during the weaning period from mechanical ventilation in the Intensive Care Unit in patients after bilateral lung transplant.
详细描述
This study is a prospective, single-center feasibility study to acquire more knowledge regarding the NeuRx DPS and develop a routine in the optimal pacing of the diaphragm with this system during the weaning period from mechanical ventilation in the Intensive Care Unit in patients after bilateral lung transplant. The objectives are to evaluate the safety and technical performance of DPS by assessing:
- the immediate safety and technical surgical results of implantation
- the safety and tolerability of use and removal until patient discharge from the Intensive Care Unit (ICU) or hospital
- the effects of diaphragm pacing on MV interaction, diaphragm force, fatigue resistance, and diaphragm electromyography (EMG)
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is undergoing bilateral lung transplantation
- •Signed written informed consent has been obtained prior to any study related procedure
排除标准
- •Diaphragm malformation which makes the electrode insertion impossible
- •Presence of contra-indications for magnetical stimulation; pacemaker or implantable cardioverter-defibrillator, prosthetic valve, cervical implants, cervical trauma
- •Participation in other clinical studies that could interfere with the results in the ongoing study
结局指标
主要结局
Tolerability: Patient withdrawal from treatment.
时间窗: 30 days
Safety: Daily assessment of device or procedure-related adverse events until patient discharge.
时间窗: 30 days
Pacing success: Ability to ventilate the patient through diaphragm pacing with or without assistance of mechanical ventilation.
时间窗: 30 days
次要结局
- Composite endpoint(30 days)