Diaphragm Pacing Therapy for Ventilator Induced Diaphragm Dysfunction
(AERO-PAS Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Are You a Good Fit for This Trial?
This trial is for adults (18+) who have been on a ventilator for at least 4 days, are unable to breathe without it yet, and recently failed a breathing test meant to see if they could come off the ventilator.Inclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Lungpacer Diaphragm Pacing Therapy
Trial Overview
The study is testing the AeroPace System, which uses diaphragm pacing therapy to help patients on long-term mechanical ventilation. All participants receive this treatment and are monitored for safety and effectiveness over 30 days.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Lungpacer Medical Inc.
Lead Sponsor
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