Randomized Study of TransAeris® System for Enhanced Recovery After Surgery (ERAS) in Cardiac Surgery Patients in France at Risk of Prolonged Mechanical Ventilation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Serious device-related adverse events
研究概览
简要总结
This study will be conducted as a randomized trial of the TransAeris system for the prevention and treatment of ventilator-induced diaphragm dysfunction (VIDD) in patients identified prior to surgery to be at greater risk of prolonged mechanical ventilation (PMV).
详细描述
This study is a monocentric and open label randomized study in adult open cardiac surgery patients. Eligible patients from whom informed consent is obtained are enrolled in the study. All subjects will be implanted with the TransLoc electrodes during their primary surgery. Patients are randomized to treatment or control groups prior to surgical placement of the TransLoc electrodes.
Comparison will be made between treatment and control patients during the initial 120 hours of study, then comparison of cross-over control patients' EMG from baseline to treatment.
Further comparison of MV Time, ventilator free days and other outcome measures will be made for all patients, over the course of the 30-day treatment period, to literature on an observational basis.
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
- None
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject is undergoing an open cardiac procedure by median sternotomy
- •Subject is at risk of prolonged mechanical ventilation according to one or more of the following criteria:
- •Prior open cardiac surgery
- •Left Ventricular Ejection Fraction (LVEF) ≤ 30%
- •History of TIA or CVA
- •Pre-operative or anticipated intraoperative intra-aortic balloon pump
- •History of COPD
- •Subject is at least 22 years of age
- •Informed consent has been obtained from the subject
- •Subject is covered by a healthcare insurance
排除标准
- •Subject is on invasive mechanical ventilation prior to procedure
- •Subject has known or pre-existing phrenic nerve paralysis
- •Subject is having a left ventricular assist device (LVAD) implanted
- •Subject has progressive, non-reversible neuromuscular disease affecting the diaphragm
- •Subject is pregnant or lactating
- •Subject is actively participating in another clinical study which could affect outcomes in this study
- •Subject deprived of liberty
- •Subject under court protection
结局指标
主要结局
Serious device-related adverse events
时间窗: 60 days after implantation
Number of serious device-related adverse effects
Time on mechanical ventilation
时间窗: 90 days after study completion
Time measured in hours on Mechanical Ventilation and Proportion of patients weaned at 48- and 120-hours post-op
次要结局
- ICU Care(90 days after study completion)
- Device related adverse events(90 days after study completion)
- Mortality(90 days after study completion)
- Mechanical ventilation time(90 days after study completion)
- EMG(90 days after study completion)
- Ventilator Free Days(90 days after study completion)
- Length of stay(90 days after study completion)