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.
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 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.
90 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 RASSAFS = 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).
A multicenter RCT evaluating AFS is feasible to conduct in North America.
•Analgesia-first sedation (AFS) has not been evaluated in a randomized trial in North America where ICU practices are different from Europe.•Enrollment, intervention adherence, and achievement of pain/sedation goals, were similar between the AFS and control groups.•Nurse and respiratory care practitioner-perceived patient workload were greater with AFS but did not exceed the feasibility benchmark.•Patient self-extubation and breakthrough propofol use were very low in the AFS group.•A multicenter study comparing AFS to traditional sedation strategies in North America appears feasible to conduct.
