Prone Positioning for Lung Transplant Outcomes

(P-POD Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Lorenzo delSorbo

Disqualifiers: HIV, Active cancer, COVID-19, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 90 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to improve the condition of donated lungs for transplant by placing brain-dead donors on their stomachs (prone position) instead of their backs (supine position) during mechanical ventilation. The researchers aim to determine if this position helps maintain healthier lungs, potentially increasing the number of lungs available for life-saving transplants for people with lung disease. Suitable candidates for this trial are individuals declared brain-dead who have consented to organ donation, without open wounds on the front of their body or certain infections or cancers. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance lung transplant success rates.

Will I have to stop taking my current medications?

The trial protocol does not specify whether participants must stop taking their current medications.

What prior data suggests that prone positioning is safe for lung transplant outcomes?

Research has shown that lying on the stomach, known as prone positioning, is generally safe. This position often aids people with breathing problems, such as those with acute respiratory distress syndrome (ARDS). Studies have also found that it can improve oxygen levels and reduce lung pressure in lung transplant patients.

However, some risks exist. One study found that while some patients could swallow safely in this position, others experienced issues like food or liquid entering the windpipe. Despite these concerns, prone positioning remains a safe and effective method to support better lung function in transplant situations. This approach could help make more donor lungs suitable for transplant. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about prone positioning for lung transplant patients because it could improve outcomes by optimizing lung function. Unlike the traditional supine position, prone positioning can enhance oxygenation and reduce ventilator-induced lung injury by distributing ventilation more evenly across the lungs. This method leverages gravity to help clear secretions and improve blood flow, potentially leading to better recovery and fewer complications post-transplant. Researchers hope to find out if these benefits can lead to significant improvements in patient outcomes compared to the standard supine positioning.

What evidence suggests that prone positioning is effective for improving lung transplant outcomes?

Research has shown that lying patients on their stomachs, known as prone positioning, improves lung function and oxygen levels after lung transplants. In this trial, participants will receive either protocolized protective mechanical ventilation in the prone position or in the supine position. Studies have found that the prone position allows the lungs to expand more easily, reducing breathing problems. In patients with severe lung issues like acute respiratory distress syndrome (ARDS), prone positioning has been linked to better survival rates and fewer complications. These findings suggest that using prone positioning in brain-dead lung donors might make more lungs suitable for transplant, potentially increasing the number of successful lung transplants. ^{1 4 5 6 7}

Are You a Good Fit for This Trial?

This trial is for brain-dead individuals who are potential lung donors. It aims to see if laying them on their stomachs (prone position) instead of their backs can improve the quality of lungs for transplant.

Inclusion Criteria

Neurological determination of death at time of study entry

Consent to organ donation

Eligible for organ donation as confirmed by Trillium Gift of Life Network Coordinator

Exclusion Criteria

Absolute contraindication to lung transplantation on initial eligibility screening: Infection - Positive HIV, HbsAg, Human T-lymphotropic virus-I/II test results, Positive West Nile Virus (WNV PCR) test results, Rabies diagnosis or within the last 6 months bitten by an animal proven to have rabies, Active endocarditis, Active encephalitis or meningitis of unknown etiology, Active disseminated tuberculosis, Viral hemorrhagic fever including Ebola or known exposure to person with Ebola, COVID-19 presumptive or confirmed positive in the last 14 days; Malignancy - Donors with active cancer (donors receiving chemotherapy or radiation therapy or palliative cancer care within the last 5 years); excluding skin and primary brain tumors and prostate cancers, Donors with a history of Lung Cancer, Choriocarcinoma, Breast Cancer, Colon Cancer within the last 10 years, Donors with active or past history of melanoma, Clinician decision that prone position is contraindicated

I have open wounds on my chest or stomach area.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Donors are positioned in either prone or supine position and undergo protocolized protective mechanical ventilation

90 days

Follow-up

Participants are monitored for protocol adherence and donor lung function outcomes

90 days

What Are the Treatments Tested in This Trial?

Interventions

• Prone Positioning

Trial Overview The study tests a method called protocolized protective mechanical ventilation in prone position, comparing it with traditional back-lying (supine) positioning to see which is better for preserving donor lung function.

How Is the Trial Designed?

Group I: Protocolized protective mechanical ventilation in prone position Experimental Treatment 1 Intervention

Group II: Protocolized protective mechanical ventilation in supine position Active Control 1 Intervention

Who Is Running the Clinical Trial?

Lorenzo delSorbo

Lead Sponsor

Trials

2

Recruited

340+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10162468/

The Effect of Prone Positioning After Lung Transplantation Prone positioning led to a significant improvement in lung compliance and oxygenation after lung transplantation.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37150273/

The Effect of Prone Positioning After Lung Transplantation Prone positioning led to a significant improvement in lung compliance and oxygenation after lung transplantation. Prospective studies are needed to confirm ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05507424

Prone Positioning During Delayed Cord Clamping This study is being done to see if placing babies on the stomach or the back during delayed cord clamping after birth will improve the outcomes of preterm ...

4. withpower.com withpower.com/trial/phase-lung-transplant-failure-3-2024-882da

Prone Positioning for Lung Transplant Outcomes · Info ... Prone positioning is known to improve oxygenation and reduce mortality in patients with acute respiratory distress syndrome (ARDS), and it has been shown to ...

5. jintensivecare.biomedcentral.com jintensivecare.biomedcentral.com/articles/10.1186/s40560-025-00795-x

The effects of prolonged prone positioning on response and ... PPP (≥ 16 h) is associated with reduced 28-day mortality and improved response rates in ICU patients with ARDS, without increasing complication risks.

6. jhltonline.org jhltonline.org/article/S1053-2498(21)00998-0/pdf

Impact of Prone Positioning after Lung Transplantation Post-Operative Dysphagia Status: 20% (n=33) demonstrated safe swallowing, 41% (n=68) penetration, while. 39% (n=65) exhibited tracheal aspiration. Swallowing ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S1053077024009169

Early Prone Positioning As a Rescue Therapy for Moderate ... Early PP in LT recipients with moderate-to-severe PGD seems to be associated with better 28-day ventilator-free days, oxygenation, and driving pressure than ...