Prone Positioning in Neurologically Deceased Potential Organ Donors to Improve Donor Lung Function and Lung Transplant Recipient Outcomes (P-POD)

Prone Positioning in Neurologically Deceased Potential Organ Donors to Improve Donor Lung Function and Lung Transplant Recipient Outcomes (P-POD) Pilot 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Lung Transplant Failure
• Intervention / Treatment: Other: Protocolized protective mechanical ventilation in prone position

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 2N2
      • Toronto General Hospital

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Age ≥ 18 years
2. Neurological determination of death at time of study entry
3. Consent to organ donation
4. Eligible for organ donation as confirmed by Trillium Gift of Life Network Coordinator

Exclusion Criteria:

1. Open chest or abdominal wounds on the ventral body surface

2. Absolute contraindication to lung transplantation on initial eligibility screening:

   • Infection i. Positive HIV, HbsAg, Human T-lymphotropic virus-I/II test results ii. Positive West Nile Virus (WNV PCR) test results iii. Rabies diagnosis or within the last 6 months bitten by an animal proven to have rabies iv. Active endocarditis v. Active encephalitis or meningitis of unknown etiology vi. Active disseminated tuberculosis vii. Viral hemorrhagic fever including Ebola or known exposure to person with Ebola viii. COVID-19 presumptive or confirmed positive in the last 14 days
   • Malignancy i. 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.

ii. Donors with a history of the following malignancies:

• Lung Cancer
• Choriocarcinoma
• Breast Cancer
• Colon Cancer within the last 10 years iii. Donors with active or past history of melanoma o Clinician decision that prone position is contraindicated

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Protocolized protective mechanical ventilation in prone position	Other: Protocolized protective mechanical ventilation in prone position; Prone Position: Study subjects randomized to the intervention group will be placed and maintained in prone position for at least 16 hours/day until the time of organ procurement or decline (typically 24-48 hours after donation consent) or the time that the lungs are declined for transplant.
No Intervention: Protocolized protective mechanical ventilation in supine position

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
This pilot randomized controlled trial will assess the feasibility of conducting a future full randomized clinical trial, specifically, to determine whether donor accrual will be adequate (if we recruit 40 donors from 4 sites over 1 year)	The number of donors enrolled into the trial over 1 year to be placed into either prone positioning or supine positioning prior to lung transplant	90 days
To document adherence to the explicit prone positioning and mechanical ventilation protocol (if more than 80% of donors have no major protocol violations then considered adequate)	Number of major protocol violations, specifically: Time from donation consent to randomization > 3 hours;; Time from randomization to initiation of study assigned protocol > 3 hours;; Time spent in prone positioning < 50% of the total time from study consent to study termination	90 days
To document the number of those who cross over to the alternate strategy (if fewer than 10% of donors cross over to the alternate strategy, when not allowed by protocol then considered adequate)	The percentage of donors who cross over to the alternate strategy, when not allowed by protocol	90 days

Collaborators and Investigators

• Sponsor: Lorenzo delSorbo

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2024
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: February 6, 2024
• First Submitted That Met QC Criteria: February 6, 2024
• First Posted (Actual): February 14, 2024

Study Record Updates

• Last Update Posted (Actual): May 9, 2024
• Last Update Submitted That Met QC Criteria: May 8, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Death
• Other Study ID Numbers: CTO 4594

Drug and device information, study documents

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