An early feasibility study to investigate the safety and feasibility of the Lungpacer Diaphragm Pacing Therapy System (DPTS) as a therapy to recondition and strengthen the diaphragm of patients who have been intubated and invasively mechanically ventilated for \> or = 7 days, have failed two or more spontaneous breathing trials (SBT), and were not hypervolemic during the latest SBT.
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Successful Placement of the LIVE Catheter
Timeframe: You will undergo an evaluation immediately following the LIVE Catheter insertion procedure to confirm that the LIVE Catheter has been successfully placed in the correct position in your vein.
Capture of phrenic nerve
Timeframe: Measured during daily Diaphragm Pacing Therapy sessions from time of LIVE Catheter insertion to time of extubation or day 30 whichever comes first
Diaphragm contraction noted upon stimulation of the phrenic nerve
Timeframe: Measured during daily Diaphragm Pacing Therapy sessions from time of LIVE Catheter insertion to time of extubation or day 30 whichever comes first.
Removal of LIVE Catheter
Timeframe: Removal of LIVE Catheter will occur 2 days after extubation or on day 30 if subject has not been extubated.