Goal of Open Lung Ventilation in Donors

Deceased organ donors are maintained on life support including mechanical ventilation during
the time between brain death and organ procurement. The optimal mode of mechanical
ventilation for deceased organ donors has not been definitively established. Since deceased
organ donors may develop atelectasis leading to impaired oxygenation, an open lung protective
ventilatory strategy with higher positive end expiratory pressure (PEEP), lower tidal volume
and recruitment maneuvers has been hypothesized to be beneficial. Favorable outcomes were
observed in a European clinical trial comparing open lung protective ventilation (OLPV) to a
conventional ventilatory strategy in terms of donor oxygenation and lung utilization for
transplantation (Mascia L et al, Journal of the American Medical Association 2010). However,
donor management procedures in Europe are much shorter in duration compared to the US and it
is not clear that these findings are generalizable to the US donor management environment.

The GOLD trial will test the effect of an OLPV strategy compared to conventional ventilation
(CV) in the US donor management environment. This multi center trial will enroll 400 brain
dead organ donors randomized into 1 of 2 treatment arms. After randomization, mechanical
ventilation will be protocolized according to treatment arm with one arm receiving control
ventilation (CV) utilizing standard Donor Network West (DNW) protocols and the other arm
receiving the OLPV strategy with higher positive end expiratory pressure (PEEP) and lower
tidal volume compared to CV. The primary outcomes is donor lung utilization for
transplantation.

Inclusion Criteria:

- Brain death

- Authorization for research

- ≥13 years of age

Exclusion Criteria:

- Arterial/Inspired oxygen ratio (PaO2/FiO2) ≤ 150 mmHg

- PaO2/FiO2 ≥ 400 mmHg

- BMI > 40

- Hepatitis B surface antigen positive

- Hepatitis C positive

- Failure to complete donation process

- Hemodynamic instability