Analgesia-first sedation in critically ill adults: A U.S. pilot, randomized controlled trial
Autor: | Gabe Flores, Ramy Sidhom, Sangeeta Mehta, Arunpal Sehgal, Maged Tanios, John W. Devlin, Hyunsoon Park, Antonio Beltran, Huan Mark Nguyen, James Leo, Scott K. Epstein, Fady Youssef |
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Rok vydání: | 2019 |
Předmět: |
Male
Time Factors Randomization Critical Illness Sedation medicine.medical_treatment Pain Pilot Projects Critical Care and Intensive Care Medicine California law.invention Fentanyl 03 medical and health sciences 0302 clinical medicine Bolus (medicine) Clinical Protocols Randomized controlled trial law Intensive care medicine Humans Pain Management Intubation Anesthesia Propofol Aged business.industry 030208 emergency & critical care medicine Middle Aged Respiration Artificial Analgesics Opioid Intensive Care Units 030228 respiratory system Feasibility Studies Drug Therapy Combination Female Analgesia medicine.symptom business medicine.drug |
Zdroj: | Journal of Critical Care. 53:107-113 |
ISSN: | 0883-9441 |
Popis: | 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 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. Results 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 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). Conclusion A multicenter RCT evaluating AFS is feasible to conduct in North America. |
Databáze: | OpenAIRE |
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