A randomized trial of open lung protective ventilation compared to conventional mechanical ventilation in deceased organ donors.

Abstract

Purpose: We conducted a randomized trial of open lung protective ventilation (OLPV) compared to conventional ventilation (CV) in deceased donors. The primary outcome was lung utilization for transplantation.

Methods: Eligible donors were ≥13 years with PaO₂/FiO₂ between 150 and 400 mmHg. Donors were randomized to volume control with OLPV [tidal volume (TV) 8 ml/kg, PEEP 10 cmH₂O, protocolized recruitment maneuvers (RM)] or CV [TV 10ml/kg, PEEP 5 cm H₂O, RM only after vent disconnect] for duration of donor management. Lungs were evaluated for transplantation on standardized ventilator settings in both arms [TV 10ml/kg, PEEP 5 cm H₂O, FiO₂ 1.0].

Results: 153 donors were randomized (74 to OLPV, 79 to CV) and included in the final analysis. Median duration of treatment was 50 hours and did not differ by arm. Donor lung utilization was 23% in the OLPV arm and 22% in the CV arm, P = 0.85. Change in PaO₂/FiO₂ from randomization to procurement did not differ by treatment; median increase (quartiles) in OLPV versus CV was 68 mmHg (18, 127) vs 74 (-27 to 170), P = 0.72. There was no difference in need for vasopressors or serious adverse events between arms. Among 28 lung recipients in whom detailed outcomes were available, duration of mechanical ventilation, ICU stay and hospital stay were not different by treatment arm.

Conclusions: An open lung protective ventilator strategy was safe but did not improve donor lung utilization or oxygenation compared to a conventional ventilator strategy in a population of US organ donors. NCT03439995.