๐ฌIn plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
Inclusion Criteria:
1. Are 18 years or older, and,
2. Will have been mechanically ventilated for โฅ96 hours (4 days) by the time of Catheter insertion, and,
3. Have not weaned from MV, and,
4. Have failed an institutional SBT within 48 hours of enrollment.
Exclusion Criteria:
1. Invasive mechanical ventilation \>90 days.
2. Currently on extracorporeal membrane oxygenation (ECMO).
3. Weaning failure due to hypervolemia.
4. Medical history (including imaging) or known anatomy that prevents percutaneous insertion of the Catheter into the intended thoracic vein on the left side.
5. Clinically overt congestive heart failure that is preventing weaning.
6. Currently being treated with neuromuscular blockade that could affect phrenic nerve / diaphragm contraction.
7. Pre-existing neurological, neuromuscular or muscular disorder that could affect the respiratory muscles.
8. Pre-existing severe chronic pulmonary fibrosis.
9. Known pleural effusions occupying greater than one third of the pleural space on either side.
10. BMI \>70 kg/m2.
11. Known or suspected phrenic nerve paralysis.
12. 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.
13. Current hemodynamic instability
14. Uncontrolled sepsis or septic shock.
15. Current or untreated bacteremia.
16. Expecting withdrawal of life support and/or shift to palliation as the goal of care.
17. Known or suspected to be pregnant or lactating.
18. Currently being treated in another clinical trial studying an experimental treatment that could affect the study primary outcome.
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What it tests
- Lungpacer Diaphragm Pacing Therapy
Sutter Health Research Institute
San Francisco, United States
๐ค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ always decide together with your own doctor.