Pacing In Organ Donors (the POD Trial) (POD)

Diaphragm Neurostimulation to Improve Lung Function in Brain Dead Donors

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.

Study Overview

• Status: Completed
• Conditions: Organ Donation; Lung; Mechanical Ventilation
• Intervention / Treatment: Device: Lungpacer AeroPace catheter and device

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.

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • B.C.
    • New Westminster, B.C., Canada, V3L 3W7
      • Royal Columbian Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pacing Arm	Device: Lungpacer AeroPace catheter and device; Diaphragm neurostimulation device for phrenic nerve pacing during mechanical ventilation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determine percent of eligible ventilator breaths delivered with LAPS-PNS	Eligible breaths are defined as those breaths in which PNS is not precluded by clinical care/procedures or subject transport.	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)	Measured in impedance units, percentage change from baseline	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	Measures of urine output (mL/kg) and creatinine (umol/L)	Under continuous observation from subject enrolment until study endpoint (organ donation), an average of 40 hours.
Average vital sign recording during LAPS-PNS dose	Collection variables include temperature (degrees celsius), heart rate (bpm), SBP/DBP, MAP, RR (breaths/min)	Under continuous observation from subject enrolment until study endpoint (organ donation), an average of 40 hours.

Collaborators and Investigators

• Sponsor: Fraser Health
• Collaborators: Lungpacer Medical Inc.; Lotte & John Hecht Memorial Foundation

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2024
• Primary Completion (Actual): December 1, 2025
• Study Completion (Actual): December 31, 2025

Study Registration Dates

• First Submitted: March 17, 2026
• First Submitted That Met QC Criteria: March 26, 2026
• First Posted (Actual): April 1, 2026

Study Record Updates

• Last Update Posted (Actual): April 8, 2026
• Last Update Submitted That Met QC Criteria: April 2, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Critical Care; Diaphragm stimulation; Lung organ donors; Phrenic nerve pacing
• Other Study ID Numbers: P-800

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD is unable other be shared due to data sharing agreements with study sponsor and research ethics approvals pertaining to brain dead patients

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No