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

NCT ID: NCT06259357

Last Updated: 2024-12-04

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-02
• Study Completion Date: 2026-08-01

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.

Conditions

Lung Transplant Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Protocolized protective mechanical ventilation in prone position

Group Type: EXPERIMENTAL

Protocolized protective mechanical ventilation in prone position

Intervention Type: OTHER

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.

Protocolized protective mechanical ventilation in supine position

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lorenzo delSorbo

OTHER

Sponsor Role: lead

Responsible Party

Lorenzo delSorbo

MD, Critical Care Medicine Department, Toronto General Hospital

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Toronto General Hospital

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

CTO 4594

Identifier Type: -

Identifier Source: org_study_id