A Post-Approval Multicenter Study to Assess the Continued Safety and Effectiveness of the AeroPac… (NCT07477054) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
A Post-Approval Multicenter Study to Assess the Continued Safety and Effectiveness of the AeroPace® System
120 participantsStarted 2026-07-01
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Exclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.