Prone vs Supine Position in Potential Organ Donors: PRODONAR Multicenter Clinical Trial

Detailed Summary

Background and justification: In Argentina, 9,650 people are on the organ transplant waiting list, including 290 who require a lung transplant. In 2022, 21 unilateral lungs, 18 bilateral lungs, and one cardiopulmonary block were implanted, representing only 1.9% of all transplants. Maintaining organ viability in potential donors (PD) is challenging because brain death triggers adrenergic activation, hemodynamic instability, and atelectasis due to mechanical ventilation and loss of respiratory muscle activity. These factors impair gas exchange and reduce the number of lungs suitable for transplantation. Ventilatory management in PDs aims to preserve lung function, minimize risks of invasive mechanical ventilation (IMV), and maintain adequate gas exchange while preventing alveolar collapse and overdistension. Strategies derived from Acute Respiratory Distress Syndrome (ARDS) include recruitment maneuvers, which may cause complications. In contrast, prone positioning improves ventilation-perfusion matching and increases functional lung parenchyma. This study proposes prone positioning as a preventive ventilatory strategy to optimize lung preservation in organ donors. Objectives: (1) Determine whether early prone positioning after BD certification increases the proportion of lungs meeting suitability criteria for transplantation. (2) Evaluate its effect on the availability of other transplantable organs and on hemodynamic stability. Methods: The PRODON-AR study is a prospective, multicenter, randomized controlled trial conducted in 10 intensive care units (ICUs) across Argentina. Recruitment began on June 1, 2023, and will continue until 250 PDs are enrolled. Participants will be randomly assigned to standard care (supine) or prone positioning following BD certification. Eligible donors will be those with confirmed BD, meeting multi-organ donation criteria, and without documented opposition to donation. Exclusion criteria include contraindications to prone positioning. Donors will be excluded from analysis if the interval between BD certification and proning exceeds 12 hours, if more than 20% of data for key variables are missing, or if clinical conditions require returning to the supine position. The primary outcome is the number of lungs suitable for transplantation. Secondary outcomes include the number of organs transplanted, vasopressor requirements, and variables related to gas exchange and respiratory mechanics.

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