NCT07505589

Pacing In Organ Donors (the POD Trial)

Diaphragm Neurostimulation to Improve Lung Function in Brain Dead Donors

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Fraser Health · Academic / Other
• Sex: All
• Age: 19 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to test the feasibility of pacing the phrenic nerve to stimulate the diaphragm in order to improve the lung function in brain dead organ donors. The main questions it aims to answer are: * Proof of concept and feasibility * Can lung function be improved in lungs that have been disqualified for donation Participants will have an AeroPace catheter inserted and will be paced on every breath up to the time of organ donation.

Detailed description

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.

Conditions

• Lung
• Organ Donation
• Mechanical Ventilation

Interventions

Type	Name	Description
DEVICE	Lungpacer AeroPace catheter and device	Diaphragm neurostimulation device for phrenic nerve pacing during mechanical ventilation.

Timeline

• Start date: 2024-01-31
• Primary completion: 2025-12-01
• Completion: 2025-12-31
• First posted: 2026-04-01
• Last updated: 2026-04-08

Locations

1 site across 1 country: Canada