Prone Positioning in Neurologically Deceased Potential Organ Donors to Improve Donor Lung Function and Lung Transplant Recipient Outcomes

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLorenzo delSorbo

About 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.

Eligibility criteria

Qualifiers

Age ≥ 18 years

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

Disqualifiers

Open chest or abdominal wounds on the ventral body surface

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.

Lung Cancer

Trial design

Treatments tested in this trial

  • Protocolized protective mechanical ventilation in prone position

Treatment groups

40 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Lorenzo delSorbo

Lead sponsor

University Health Network, Toronto

Sponsor institution