Decannulation from venovenous extracorporeal membrane oxygenation (ECMO) at the earliest safe opportunity would be expected to improve patient outcomes. Currently, the manner in which clinicians liberate patients from venovenous ECMO is highly variable. Whether performing a daily protocolized assessment of readiness for decannulation decreases the time to decannulation for patients receiving venovenous ECMO is unknown.

Does the performance of a daily protocolized assessment of readiness to decannulate from ECMO (an ECMO-free protocol) decrease the time to successful decannulation compared with usual care among patients receiving venovenous ECMO?

The ECMO-Free Trial is a pragmatic, multicenter, unmasked, parallel-group randomized trial being conducted in 7 sites in North America. The trial compares the daily performance of an ECMO-free protocol in which the sweep gas flow rate of patients who meet safety criteria is turned to 0 L/min (simulating the patient not receiving ECMO) with that of usual care among 225 adults receiving venovenous ECMO. The primary outcome is the time to successful decannulation from ECMO within 60 days. The secondary outcome is the number of ECMO-free days to day 60. Enrollment began on September 7, 2022, and is expected to conclude in 2026.

The ECMO-Free Trial will provide important data on the effects of a protocolized assessment of readiness to decannulate vs usual care on the time to decannulation and other outcomes among patients receiving venovenous ECMO. Specifying the protocol and statistical analysis plan before the conclusion of enrollment increases the rigor, reproducibility, and transparency of the trial.