LungPODNCT07505589
Pacing In Organ Donors (the POD Trial)
A study testing Lungpacer AeroPace catheter and device in people with Lung and Organ Donation, run by Fraser Health at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 100 years
- Conditions the study is for
- Lung, Organ Donation, Mechanical Ventilation
- What is being tested?
- Lungpacer AeroPace catheter and device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteCanada
- Study dates
- 31 Jan 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Lungpacer AeroPace catheter and device
- Keywords
- Lung organ donors, Phrenic nerve pacing, Diaphragm stimulation, Critical Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lungpacer AeroPace catheter and deviceDevice
Diaphragm neurostimulation device for phrenic nerve pacing during mechanical ventilation.
| Study group | Role | What they receive |
|---|---|---|
| Pacing Arm | Experimental | Not described Receives: Device: Lungpacer AeroPace catheter and device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in PaO2/FiO2 ratios from baseline
PaO2/FiO2 ratio measured from arterial blood gas values.
Measured: 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.
Measured: 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
Eligible breaths are defined as those breaths in which PNS is not precluded by clinical care/procedures or subject transport.
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: Under continuous observation from subject enrolment until study endpoint (organ donation), an average of 40 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2026
- Study start31 Jan 2024
- Primary completion1 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LungStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fraser Health
- Sponsor type
- University, hospital or other
- Collaborators
- Lotte & John Hecht Memorial Foundation, Lungpacer Medical Inc.
- Responsible party
- Principal investigator, Steve Reynolds, Fraser Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07505589
- Sponsor's protocol ID
- P-800
- Acronym
- POD
- Status last verified
- Mar 2026
- First submitted
- 17 Mar 2026
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD is unable other be shared due to data sharing agreements with study sponsor and research ethics approvals pertaining to brain dead patients
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diaphragm Neurostimulation to Improve Lung Function in Brain Dead Donors
- ClinicalTrials.gov ID
- NCT07505589
- Acronym / sponsor ID
- POD / P-800
- Conditions
- Lung, Organ Donation, Mechanical Ventilation
- Keywords
- Lung organ donors, Phrenic nerve pacing, Diaphragm stimulation, Critical Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Fraser HealthUniversity, hospital or other
- Collaborators
- Lotte & John Hecht Memorial Foundation, Lungpacer Medical Inc.
- Study start
- 31 Jan 2024 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 1 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Pacing Arm | Experimental | Device: Lungpacer AeroPace catheter and device |
Who may qualify
- Ages
- 19 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lungpacer AeroPace catheter and deviceDiaphragm neurostimulation device for phrenic nerve pacing during mechanical ventilation. | Device | Pacing Arm |
Primary outcome
Change in PaO2/FiO2 ratios from baseline
Time frame: ABG measurements will be taken every 6 hours from enrolment until study endpoint for each participant.
PaO2/FiO2 ratio measured from arterial blood gas values.
Number of safety events
Time frame: Under continuous observation from subject enrolment until study endpoint (organ donation), an average of 40 hours.
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.
6 secondary outcomes
Determine percent of eligible ventilator breaths delivered with LAPS-PNS
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Under continuous observation from subject enrolment until study endpoint (organ donation), an average of 40 hours.
Average vital sign recording during LAPS-PNS dose
Time frame: Under continuous observation from subject enrolment until study endpoint (organ donation), an average of 40 hours.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Individual participant dataSharing planned: No. IPD is unable other be shared due to data sharing agreements with study sponsor and research ethics approvals pertaining to brain dead patients
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lungpacer AeroPace catheter and device in people with Lung and Organ Donation, run by Fraser Health at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in PaO2/FiO2 ratios from baseline (time frame: ABG measurements will be taken every 6 hours from enrolment until study endpoint for each participant.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.