• Maged Tanios, Huan Mark Nguyen, Hyunsoon Park, Sangeeta Mehta, Scott K Epstein, Fady Youssef, Antonio Beltran, Gabe Flores, Ramy Sidhom, Arunpal Sehgal, James Leo, and John W Devlin.
• Division of Pulmonary and Critical Care Medicine, MemorialCare Long Beach Medical Center, Long Beach, CA, United States of America.
• J Crit Care. 2019 Oct 1; 53: 107-113.

PurposeTo determine the feasibility of conducting a multicenter ICU RCT of AFS compared to either protocol-directed sedation (PDS) or both PDS and daily sedation interruption (DSI) in North America.Materials And MethodsThis single-center RCT compared AFS [fentanyl (bolus ± infusions) to reach CPOT ≤2; if RASS ≥1, CPOT ≤2 and additional fentanyl failed to reach RASS goal (-2 to 0), low-dose propofol (up to 6 h) was given] with either PDS or both PDS and DSI daily in adults mechanically ventilated (MV) ≥48 h. Relevant feasibility, safety, and clinical outcomes were defined and evaluated.Results90 of 160 eligible patients were enrolled [AFS = 27; PDS = 28; PDS + DSI = 31]; rate = 3/month. Time from intubation to randomization was 17.5 ± 11.6 h. Study days fully adherent to the study intervention [AFS = 95%; PDS = 99%; PDS + DSI = 96%] and time spent in the first 48 h after randomization without pain (CPOT ≤2)[AFS = 82%; PDS = 78%; PDS + DSI = 77%] and at goal RASS[AFS = 88%; PDS = 83%; PDS + DSI = 95%] were high and similar. Nurse-perceived [median (IQR)] study workload (10-point VAS) was higher with AFS [4(2-6)] than PDS [1(1-3)] or PDS + DSI [2(1-5)]; p = .002). Unplanned extubation was rare (AFS = 1; PDS = 0; PDS + DSI = 1). Days [median (IQR)] free of MV in the 28d after intubation [AFS 24(23,26); PDS 24(20,26); PDS + DSI 24(21,26)] was not different (p = .62).ConclusionA multicenter RCT evaluating AFS is feasible to conduct in North America.Copyright © 2019 Elsevier Inc. All rights reserved.

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