Clinical trial NCT06259357: Prone Positioning in Neurologically Deceased Potential Organ Donors to Improve Donor Lung Function and Lung Transplant Recipient Outcomes
Official title: Prone Positioning in Neurologically Deceased Potential Organ Donors to Improve Donor Lung Function and Lung Transplant Recipient Outcomes (P-POD) Pilot Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Lung Transplant Failure
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2024-02-14
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: 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)
timeFrame: 90 days
measure: 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)
timeFrame: 90 days
measure: 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)
timeFrame: 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
Study officials:
References: