Lungpacer Medical Inc.
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.
Inclusion Criteria: 1. Are 18 years or older, and, 2. Will have been mechanically ventilated for ≥96 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 ov…
Transvenous phrenic nerve stimulation to induce diaphragm contraction.
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