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

40 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to determine the practicality of performing a future, large-scale study. The future study will look at the effect of mechanical ventilation in neurologically deceased (brain-dead) lung donors who are positioned to lay flat on their stomach (prone position), compared to donors who are positioned to lay flat on their back (supine position). The study will also look at the potential impact of prone positioning of the donor on transplant recipients of the study organs. The investigators are doing this study because the investigators want to increase the availability of donor lungs for lung transplant. Lung transplant is a life-saving treatment for individuals with lung disease, but there are not enough donated lungs to meet demand. Researchers are looking for better ways of preventing donated lungs from becoming unsuitable for transplant. Because of this, the goal of our study is to test whether prone positioning in neurologically deceased (brain-dead) lung donors can improve donor lung function and decrease complications, potentially increasing the number of donor lungs that can be used for transplant.

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment Prone Positioning for lung transplant outcomes?

Prone positioning is known to improve oxygenation and reduce mortality in patients with acute respiratory distress syndrome (ARDS), and it has been shown to increase lung volume and improve breathing in severe respiratory failure. While specific data for lung transplant patients is limited, these benefits in similar conditions suggest it could be helpful. ^{1 2 3 4 5}

Is prone positioning generally safe for humans?

Prone positioning is generally considered safe and is used to improve breathing in conditions like acute respiratory distress syndrome (ARDS). However, some studies note that there can be complications, so strategies are recommended to minimize these risks. ^{1 6 7 8 9}

How does the treatment of prone positioning differ from other treatments for lung transplant outcomes?

Prone positioning is unique because it involves placing patients on their stomachs to improve oxygenation and gas exchange, which is different from traditional treatments that focus on mechanical ventilation. This method has been widely used in acute respiratory distress syndrome (ARDS) and is now being explored for its potential benefits in lung transplant recipients. ^{1 3 10 11 12}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

The Effect of Prone Positioning After Lung Transplantation. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Prone ventilation--it's time. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Prone Positioning for Acute Hypoxemic Respiratory Failure and ARDS: A Review. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Prone positioning: is it safe and effective? [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Prone positioning in acute respiratory distress syndrome. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Effect of prone positioning on clinical outcomes in children with acute lung injury: a randomized controlled trial. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Prone positioning in the patient who has acute respiratory distress syndrome: the art and science. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Adverse Events of Prone Positioning in Mechanically Ventilated Adults With ARDS. [2023]

9. Italy pubmed.ncbi.nlm.nih.gov

Postraumatic ARDS: how to place patients who may offer technical problems in a prone position. [2020]

10. United States pubmed.ncbi.nlm.nih.gov

Efficacy of prone position in acute respiratory distress syndrome patients: A pathophysiology-based review. [2020]

11. France pubmed.ncbi.nlm.nih.gov

Prone positioning in acute respiratory distress syndrome (ARDS): when and how? [2020]

12. England pubmed.ncbi.nlm.nih.gov

The role of prone positioning in patients with SARS-CoV-2-related respiratory failure in non-intensive care unit. [2023]