Pacing In Organ Donors (the POD Trial)

Single-center, single-arm, proof-of-concept trial. Up to twenty (20) subjects on mechanical ventilation who are determined to be brain dead and whose lungs are declined for donation based on a PaO2/FiO2 ratio \< 300 mmHg will be enrolled. Subjects may also be enrolled in the study at the request of the donation team if the lungs are accepted for donation but of marginal quality. Consent from the temporary substitute decision maker (TSDM) will be obtained for (i) organ donation and (ii) for study participation. All subjects will receive Lungpacer AeroPace Protect System catheter-based transvenous phrenic nerve stimulation (LAPS-PNS) with lung-protective mechanical ventilation and standard of care for transplant donors. Insertion of the AeroPace Catheter will be conducted as soon as possible after the determination of lung transplant ineligibility. LAPS-PNS will be titrated with the ventilator to provide a contribution to the work of breathing sufficient to retain diaphragm activation. Measurements to determine the effects of LAPS-PNS on donor lung function and physiology will be conducted until the time of organ donation. An esophageal-gastric manometer and electrical impedance tomography (EIT) unit will be utilized, respectively, to assess transdiaphragmatic pressure and lung volume distribution. Data collected for brain dead donors admitted to the same ICU over the 2 years preceding the study start who did not qualify for lung donation will serve as an unmatched comparator group.