TY - JOUR
T1 - The Feasibility of Implementing Targeted SEDation in Mechanically Ventilated Emergency Department Patients
T2 - The ED-SED Pilot Trial∗
AU - Fuller, Brian M.
AU - Roberts, Brian W.
AU - Mohr, Nicholas M.
AU - Faine, Brett
AU - Drewry, Anne M.
AU - Wessman, Brian T.
AU - Ablordeppey, Enyo
AU - Pappal, Ryan D.
AU - Stephens, Robert J.
AU - Sewatsky, Thomas
AU - Cho, Nicholas S.
AU - Yan, Yan
AU - Kollef, Marin H.
AU - Carpenter, Christopher R.
AU - Avidan, Michael S.
N1 - Funding Information:
Drs. Fuller’s, Roberts’, and Mohr’s institutions received funding from the National Heart, Lung, and Blood Institute. Drs. Fuller, Roberts, Mohr, Faine, and Yan received support for article research from the National Institutes of Health. Dr. Fuller is supported by the National Heart, Lung, and Blood Institute of the National Institutes of Health under award number R34HL150404. Dr. Kollef is supported by the Barnes-Jewish Hospital Foundation. The remaining authors have disclosed that they do not have any potential conflicts of interest.
Publisher Copyright:
© 2022 Lippincott Williams and Wilkins. All rights reserved.
PY - 2022/8/1
Y1 - 2022/8/1
N2 - OBJECTIVES: Deep sedation in the emergency department (ED) is common, increases deep sedation in the ICU, and is negatively associated with outcome. Limiting ED deep sedation may, therefore, be a high-yield intervention to improve outcome. However, the feasibility of conducting an adequately powered ED-based clinical sedation trial is unknown. Our objectives were to assess trial feasibility in terms of: 1) recruitment, 2) protocol implementation and practice change, and 3) safety. Patient-centered clinical outcomes were assessed to better plan for a future large-scale clinical trial. DESIGN: Pragmatic, multicenter (n = 3), prospective before-after pilot and feasibility trial. SETTING: The ED and ICUs at three medical centers. PATIENTS: Consecutive, adult mechanically ventilation ED patients. INTERVENTIONS: An educational initiative aimed at reliable ED sedation depth documentation and reducing the proportion of deeply sedated patients (primary outcome). MEASUREMENTS AND MAIN RESULTS: Sedation-related data in the ED and the first 48 ICU hours were recorded. Deep sedation was defined as a Richmond Agitation-Sedation Scale of -3 to -5 or a Sedation-Agitation Scale of 1-3. One thousand three hundred fifty-six patients were screened; 415 comprised the final population. Lighter ED sedation was achieved in the intervention group, and the proportion of deeply sedated patients was reduced from 60.2% to 38.8% (p < 0.01). There were no concerning trends in adverse events (i.e., inadvertent extubation, device removal, and awareness with paralysis). Mortality was 10.0% in the intervention group and 20.4% in the preintervention group (p < 0.01). Compared with preintervention, the intervention group experienced more ventilator-free days [22.0 (9.0) vs 19.9 (10.6)] and ICU-free days [20.8 (8.7) vs 18.1 (10.4)], p < 0.05 for both. CONCLUSIONS: This pilot trial confirmed the feasibility of targeting the ED in order to improve sedation practices and reduce deep sedation. These findings justify an appropriately powered clinical trial regarding ED-based sedation to improve clinical outcomes.
AB - OBJECTIVES: Deep sedation in the emergency department (ED) is common, increases deep sedation in the ICU, and is negatively associated with outcome. Limiting ED deep sedation may, therefore, be a high-yield intervention to improve outcome. However, the feasibility of conducting an adequately powered ED-based clinical sedation trial is unknown. Our objectives were to assess trial feasibility in terms of: 1) recruitment, 2) protocol implementation and practice change, and 3) safety. Patient-centered clinical outcomes were assessed to better plan for a future large-scale clinical trial. DESIGN: Pragmatic, multicenter (n = 3), prospective before-after pilot and feasibility trial. SETTING: The ED and ICUs at three medical centers. PATIENTS: Consecutive, adult mechanically ventilation ED patients. INTERVENTIONS: An educational initiative aimed at reliable ED sedation depth documentation and reducing the proportion of deeply sedated patients (primary outcome). MEASUREMENTS AND MAIN RESULTS: Sedation-related data in the ED and the first 48 ICU hours were recorded. Deep sedation was defined as a Richmond Agitation-Sedation Scale of -3 to -5 or a Sedation-Agitation Scale of 1-3. One thousand three hundred fifty-six patients were screened; 415 comprised the final population. Lighter ED sedation was achieved in the intervention group, and the proportion of deeply sedated patients was reduced from 60.2% to 38.8% (p < 0.01). There were no concerning trends in adverse events (i.e., inadvertent extubation, device removal, and awareness with paralysis). Mortality was 10.0% in the intervention group and 20.4% in the preintervention group (p < 0.01). Compared with preintervention, the intervention group experienced more ventilator-free days [22.0 (9.0) vs 19.9 (10.6)] and ICU-free days [20.8 (8.7) vs 18.1 (10.4)], p < 0.05 for both. CONCLUSIONS: This pilot trial confirmed the feasibility of targeting the ED in order to improve sedation practices and reduce deep sedation. These findings justify an appropriately powered clinical trial regarding ED-based sedation to improve clinical outcomes.
KW - emergency department
KW - feasibility
KW - implementation
KW - mechanical ventilation
KW - pilot trial
KW - sedation
UR - http://www.scopus.com/inward/record.url?scp=85134435406&partnerID=8YFLogxK
U2 - 10.1097/CCM.0000000000005558
DO - 10.1097/CCM.0000000000005558
M3 - Article
C2 - 35404327
AN - SCOPUS:85134435406
SN - 0090-3493
VL - 50
SP - 1224
EP - 1235
JO - Critical Care Medicine
JF - Critical Care Medicine
IS - 8
ER -