CompletedNot Applicable

Pacing In Organ Donors (the POD Trial)

Canada3 participantsStarted 2024-01-31

Plain-language 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.

Who can participate

Age range

19 Years – 100 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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 * 2nd or 3rd degree heart block on at least 2 EKGs conducted during routine care, * Treating physician deems enrollment not clinically appropriate for other reason

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial studied pacing in organ donors on mechanical ventilation — can you explain what 'pacing' means in this context and how it was being used to try to improve lung function before donation?
2The trial measured changes in PaO2/FiO2 ratios as its main outcome — in plain terms, what does that ratio tell us about how well the lungs are working, and why would improving it matter for donated lungs?
3Since the trial tracked safety events as a primary outcome, what kinds of risks or complications were they specifically watching for, and what did the completed results suggest about safety?
4Now that this trial is completed, has the data been published or shared anywhere, and is there anything in the findings that might change how organ donation or lung preservation is managed in our situation?
5Are there any follow-on studies or current protocols being considered based on what this trial found, and is that something worth factoring into decisions our family is facing right now?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in PaO2/FiO2 ratios from baseline

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

Number of safety events

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

Trial details

NCT IDNCT07505589

SponsorFraser Health

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-01

View on ClinicalTrials.gov More Lung trials