RESUMO
PURPOSE: To 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 METHODS: This 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 6â¯h) was given] with either PDS or both PDS and DSI daily in adults mechanically ventilated (MV) ≥48â¯h. Relevant feasibility, safety, and clinical outcomes were defined and evaluated. RESULTS: 90 of 160 eligible patients were enrolled [AFSâ¯=â¯27; PDSâ¯=â¯28; PDSâ¯+â¯DSIâ¯=â¯31]; rateâ¯=â¯3/month. Time from intubation to randomization was 17.5⯱â¯11.6â¯h. Study days fully adherent to the study intervention [AFSâ¯=â¯95%; PDSâ¯=â¯99%; PDSâ¯+â¯DSIâ¯=â¯96%] and time spent in the first 48â¯h after randomization without pain (CPOT ≤2)[AFSâ¯=â¯82%; PDSâ¯=â¯78%; PDSâ¯+â¯DSIâ¯=â¯77%] and at goal RASS[AFSâ¯=â¯88%; PDSâ¯=â¯83%; PDSâ¯+â¯DSIâ¯=â¯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 PDSâ¯+â¯DSI [2(1-5)]; pâ¯=â¯.002). Unplanned extubation was rare (AFSâ¯=â¯1; PDS =â¯0; PDSâ¯+â¯DSIâ¯=â¯1). Days [median (IQR)] free of MV in the 28d after intubation [AFS 24(23,26); PDS 24(20,26); PDSâ¯+â¯DSI 24(21,26)] was not different (pâ¯=â¯.62). CONCLUSION: A multicenter RCT evaluating AFS is feasible to conduct in North America.