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59: EARLY GOAL DIRECTED SEDATION VS STANDARD CARE SEDATION IN MECHANICALLY VENTILATED CRITICALLY ILL ADULTS; A RANDOMIZED CONTROLLED PILOT TRIAL

Shehabi, Yahya; Bellomo, Rinaldo; Reade, Michael; Bailey, Michael; Bass, Frances; Howe, Belinda; McArthur, Colin; Seppelt, Ian; Webb, Steve; Weisbrodt, Leonie

doi: 10.1097/01.ccm.0000424315.78625.a4
Oral Abstract Session: ABSTRACT Only

Introduction: Early deep sedation (first 48 hrs) of mechanical ventilation is poorly accounted for in clinical trials and is linked to poor outcomes including mortality. We aim to assess the feasibility, safety and efficacy of Early Goal Directed Sedation (EGDS) algorithm vs standard care (STDS) in reducing early deep sedation

Hypothesis: EGDS using a dexmedetomidine (Dex) algorithm reduces early deep sedation

Methods: Prospective multicenter (6 ICUs) randomized controlled trial in critically ill adults needing IV sedation & mechanically ventilated for > 24 hours. Patients with primary neurological injury were excluded. Patients randomized to EGDS received Dex (starting at 1 mcg/kg/hr with 0-1.5 mcg/kg/hr range) based algorithm targeted to light sedation (Richmond Agitation Sedation Score -2 to +1). Patients in STDS received as directed by treating clinician

Results: The main feasibility outcomes were time to randomization, proportion of RASS assessments in the first 48 hours in the light sedation range. Safety outcomes were delirium-free days, vasopressor, physical restraints use and device removal. Randomization occurred within a median [Interquartile range] of 66[45-105] minutes after intubation or ICU admission for out of ICU intubation. Patients in the EGDS (n=21) mean (standard deviation) APACHEII score was 20.2(6.2) vs. 18.6(8.8), (P=0.53) in the STDS (n=16). A significantly higher proportion of patients in the EGDS was lightly sedated on day 1, 2 and 3 [12/19(63.2%), 19/21(90.5%) and 18/20(90%) vs STDS 2/14(14.3%), 8/15(53.3%) and 9/15(60%) (P=0.005, 0.011, 0.036)] with higher RASS assessments between (-2 to +1), in the first 48 hours 203/307(66%) vs.(74/197(38%) (P=0.001) respectively. EGDS patients received midazolam on 6/173(3.5%) and Dex was given on 4/114(3.5%) STDS patient-days. Propofol was given to 16/21(76%) of EGDS vs. 16/16(100%) of STDS patients (P=0.04). EGDS patients had 101/175(58%) vs. 54/114(47%) (P=0.09) delirium free days and required significantly less physical restraints 1(5%) vs. 5(31%) (P=0.03) than STDS patients

Conclusions: Delivery of EGDS was feasible, achieved early light sedation, minimized other sedatives and reduced physical restraints use. Further investigation of EGDS is needed

University New South Wales

The Austin Hospital

Royal Brisbane Hospital

ANZIC RC

Royal North Shore Hospital

ANZIC RC

Auckland Hospital

Nepean Hospital

Royal Perth Hospital

Nepean Hospital

© 2012 by the Society of Critical Care Medicine and Lippincott Williams & Wilkins