A Post-Approval Multicenter Study to Assess the Continued Safety and Effectiveness of the AeroPace® System

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.
• Pre-existing severe chronic pulmonary fibrosis.
• Known pleural effusions occupying greater than one third of the pleural space on either side.
• BMI >70 kg/m2.
• 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.