Randomized Study of TransAeris® System for Enhanced Recovery After Surgery (ERAS) in Cardiac Surgery Patients at Risk of Prolonged Mechanical Ventilation
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Number of subjects experiencing serious device-related adverse effects
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 an open label, randomized, cross-over study in adult open cardiac surgery patients. All subjects will receive TransLoc electrodes at the time of open sternotomy cardiac procedure. Half of subjects will have TransAeris turned on upon entry to ICU, the other half will receive standard of care with TransAeris turned on if still intubated on mechanical ventilation after 120 hours.
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 patient
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 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
结局指标
主要结局
Number of subjects experiencing serious device-related adverse effects
时间窗: 60 days after implantation
All participants will be assessed for serious device-related adverse effects
Proportion of subjects weaned at 48 hours and 120 hours
时间窗: 90 days after study completion
Time on mechanical ventilation will be compared between the Control and Treatment groups
次要结局
- Average number of days in the Intensive Care Unit (ICU)(90 days after study completion)
- Number of subjects experiencing device-related adverse events(90 days after study completion)
- Average number of days in the hospital(90 days after study completion)