A Randomized, Controlled, Open-labeled, Multi-center Clinical Trial to Evaluate the Safe and Effective Performance of the Lungpacer Diaphragm Pacing Therapy System in Patients Who Have Failed to Wean From Mechanical Ventilation.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 223
- 试验地点
- 66
- 主要终点
- Successful Weaning
研究概览
简要总结
This clinical investigation is an open-label, multi-center RCT to demonstrate the safety and effective performance of the Lungpacer DPTS (plus standard of care) as compared to Control (standard of care only) in patients aged 18 years or older who are receiving mechanical ventilation. Eligible Subjects will have received mechanical ventilation for ≥96 hours (4 days) and have failed two weaning attempts.
The goal or outcome is to show a numerically greater proportion of subjects weaned in the Treatment (Lungpacer DPTS) group as compared to the Control group.
详细描述
The intended patient population is applicable for Lungpacer DPT because there are no noninvasive alternative treatments for patients who are difficult to wean from MV (i.e., ≥96 hours (4 days) on MV) or who have required prolonged MV (>7 days). The intended patient population includes approximately one-third of all patients on mechanical ventilation. Under standard of care, approximately 50% of these patients will recover from mechanical ventilation (Jung, 2016). Standard of care involves daily weaning attempts, known as Spontaneous Breathing Trials (SBTs) or Ventilator Liberation Trials (VLTs) that are intended to encourage diaphragm use and strengthening over time.Therefore, Lungpacer DPT efficacy evaluation must be compared to standard of care in a Control group. Lack of recovery from mechanical ventilation may be due to the inability of a patient to participate in VLTs or weaning attempts, due to extensive diaphragm weakness or sedation, the inability of VLTs to induce sufficient diaphragm strengthening, or co-morbidities that prevent recovery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Are 18 years or older, and,
- •Have been mechanically ventilated for ≥96 hours (4 days), and,
- •Have satisfied the Readiness-to-Wean criteria, and,
- •Have failed at least 2 weaning attempts (that were conducted at least 48 hours after initiation of MV, and, that were conducted on different calendar days, and, at least one of which was the protocol-specific Ventilator Liberation Trial).
排除标准
- •MIP (absolute value) >50 cm H2O;
- •Invasive mechanical ventilation >90 days;
- •Currently on ECMO;
- •Weaning failure due to hypervolemia;
- •Medical history (including imaging) or known anatomy that prevents percutaneous insertion of the Catheter into the intended thoracic vein on the left side.
- •Clinically overt congestive heart failure that is preventing weaning;
- •Currently being treated with neuromuscular blockade;
- •Pre-existing neurological, neuromuscular or muscular disorder that could affect the respiratory muscles;
- •Pre-existing severe chronic pulmonary fibrosis;
- •Pleural effusions occupying greater than one third of the pleural space on either side;
- •BMI >45 kg/m2;
- •Known or suspected phrenic nerve paralysis;
- •Any electrical device (implanted or external) that may be prone to interaction with, or interference from the Lungpacer DPTS including neurological pacing/stimulator devices, cardiac pacemakers and defibrillators;
- •Current hemodynamic instability, sepsis or septic shock;
- •Prior bacteremia reported within the last 48 hours;
- •Anticipating withdrawal of life support and/or shift to palliation as the goal of care;
- •Known or suspected to be pregnant or lactating;
- •Currently being treated in another clinical trial studying an experimental treatment that could affect the study primary outcome.
结局指标
主要结局
Successful Weaning
时间窗: 30 days
The proportion of subjects who are successfully weaned will be statistically significantly greater for subjects randomized to Treatment (Lungpacer DPTS) compared to subjects randomized to Control.
Adverse Event Profile
时间窗: 30 days
Characterize the adverse event profile to support an observed consistent risk profile for subjects randomized to Treatment compared to subjects randomized to Control.
次要结局
- Days on MV(Successful weaning or Day 30)
- Maximal Inspiratory Pressure (MIP) Change(30 days)
- Rapid Shallow Breathing Index (RSBI) Change(30 days)
- Mortality(30 days)