Pacing In Organ Donors (the POD Trial)

NCT07505589 | Completed

• 1 other identifier: P-800
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lung; Organ Donation; Mechanical Ventilation

Keywords

Lung organ donors; Phrenic nerve pacing; Diaphragm stimulation; Critical Care

Outcome Measures

Primary Outcomes (2)

• Change in PaO2/FiO2 ratios from baseline

  PaO2/FiO2 ratio measured from arterial blood gas values.

  ABG measurements will be taken every 6 hours from enrolment until study endpoint for each participant.

• Number of safety events

  Determine whether any unexpected, or device-related or procedure-related complications occur in brain dead subjects. Standardized checklists will be developed to track safety events including arrhythmia, bradycardia, discomfort, hypertension/hypotension, inappropriate stimulation, pain or discomfort, phrenic nerve damage or injury, and syncope.

  Under continuous observation from subject enrolment until study endpoint (organ donation), an average of 40 hours.

Secondary Outcomes (6)

• Determine percent of eligible ventilator breaths delivered with LAPS-PNS

  Under continuous observation from subject enrolment until study endpoint (organ donation), an average of 40 hours.

• Change in distribution of ventilation using Electrical Impedance Tomography (EIT)

  Under continuous observation from subject enrolment until study endpoint (organ donation), an average of 40 hours.

• Total vasopressor use (mg/mL) during LAPS-PNS use

  Under continuous observation from subject enrolment until study endpoint (organ donation), an average of 40 hours.

• Total fluid administration (mL/kg) during LAPS-PNS dose

  Under continuous observation from subject enrolment until study endpoint (organ donation), an average of 40 hours.

• Change in kidney function during LAPS-PNS dose from baseline

  Under continuous observation from subject enrolment until study endpoint (organ donation), an average of 40 hours.

Study Arms (1)

Pacing Arm

EXPERIMENTAL

Device: Lungpacer AeroPace catheter and device

Interventions

Lungpacer AeroPace catheter and device DEVICE

Diaphragm neurostimulation device for phrenic nerve pacing during mechanical ventilation.

Pacing Arm

Eligibility Criteria

• Age: 19 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Designated as brain dead according to BC provincial guidelines, and
• Are 19 years or older, and
• Are mechanically ventilated, and
• TSDM consented for organ donation, and
• TSDM consented to study participation, and
• Accepted by BC transplant team to donate at least 1 organ system, and
• Declined by BC transplant team for lung donation based on hypoxia with the PaO2/FiO2ratio \< 300 mmHg or other criterion that precludes lung donation as requested by the organ donation team.

You may not qualify if:

• Greater than 8 hours from time declined for lung donation and initiation of LAPS-PNS,
• Inability to place a central venous catheter in the left internal jugular or left subclavian vein,
• Neuromuscular disease (e.g., Amyotrophic Lateral Sclerosis, Guillain-Barre),
• Previous phrenic nerve injury,
• Spinal cord injury above the 6th cervical spine level,
• Implanted electronic cardiac or neurostimulation device in situ
• nd or 3rd degree heart block on at least 2 EKGs conducted during routine care,
• Treating physician deems enrollment not clinically appropriate for other reason

Sponsors & Collaborators

• Fraser Health: lead
• Lungpacer Medical Inc.: collaborator
• Lotte & John Hecht Memorial Foundation: collaborator

Study Sites (1)

Royal Columbian Hospital

New Westminster, B.C., V3L 3W7, Canada

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is a single-center, single-arm, proof-of-concept trial designed to establish the feasibility of LAPS-PNS for maintaining diaphragm activation with mechanical ventilation in donors after brain death whose lungs are ineligible for transplantation due to a PaO2/FiO2 ratio \< 300 mmHg. This study will determine the number of subjects in whom LAPS-PNS can recover lung function as shown by a PaO2/FiO2 ratio \> 300 mmHg by the time of organ donation.

Study Record Dates

• First Submitted: March 17, 2026
• First Posted: April 1, 2026
• Study Start: January 31, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 31, 2025
• Last Updated: April 8, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)