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

NCT06259357 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-12-04

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Lorenzo delSorbo

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-02
Primary Completion
2025-08-01
Completion
2026-08-01

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06259357 on ClinicalTrials.gov