A Post-Approval Multicenter Study to Assess the Continued Safety and Effectiveness of the AeroPace® System - The AERO-PAS Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 主要终点
- Adverse Event Profile
研究概览
简要总结
A single-arm, prospective, multicenter cohort study to assess the 30-day continued safety and effectiveness of the AeroPace System in patients on mechanical ventilation (MV) at least 96 hours and who have not weaned. This is a study collecting real-world data in a post-market setting.
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
- 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,
- •Will have been mechanically ventilated for ≥96 hours (4 days) by the time of Catheter insertion, and,
- •Have not weaned from MV, and,
- •Have failed an institutional SBT within 48 hours of enrollment.
排除标准
- •Invasive mechanical ventilation >90 days.
- •Currently on extracorporeal membrane oxygenation (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 that could affect phrenic nerve / diaphragm contraction.
- •Pre-existing neurological, neuromuscular or muscular disorder that could affect the respiratory muscles.
- •Pre-existing severe chronic pulmonary fibrosis.
- •Known pleural effusions occupying greater than one third of the pleural space on either side.
- •BMI >70 kg/m
- •Known or suspected phrenic nerve paralysis.
- •Any electrical device (implanted or external) that may be prone to interaction with, or interference from the AeroPace System, including neurological pacing/stimulator devices, cardiac pacemakers and defibrillators.
- •Current hemodynamic instability
- •Uncontrolled sepsis or septic shock.
- •Current or untreated bacteremia.
- •Expecting 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.
研究组 & 干预措施
Lungpacer AeroPace Therapy
Subject receives AeroPace therapy consisting of 60 stimulations, twice daily for a total of 120 stimulations/day, plus standard of care for weaning from mechanical ventilation including at least once daily spontaneous breathing trials.
干预措施: Lungpacer Diaphragm Pacing Therapy (Device)
结局指标
主要结局
Adverse Event Profile
时间窗: 30 days
All Serious Adverse Events from enrollment to study exit and device- and/or procedure-related Adverse Events until successful wean, withdrawal/death, transfer or day 30 (whichever comes first).
Successful Weaning
时间窗: 30 days
Proportion of subjects successfully weaned by Day 30
次要结局
- Days on mechanical ventilation from time of initial placement procedure through Day 30.(30 days)
- Incidence of reintubation/reinstatement of MV through Day 30(30 days)
- Incidence of device/procedure related SAEs as compared to RESCUE 3 Treatment group subjects(30 days)
- Mortality through Day 30(30 days)
- Incidence of tracheostomy from enrollment through Day 30(30 days)
- ICU/hospital days from initial placement procedure to Day 32(32 days)