Fuller, Brian M.; Roberts, Brian W.; Mohr, Nicholas M.;
Faine, Brett; Drewry, Anne M.; Wessman, Brian T.; Ablordeppey, Enyo; Pappal,
Ryan D.; Stephens, Robert J.; Sewatsky, Thomas; Cho, Nicholas S.; Yan, Yan;
Kollef, Marin H.; Carpenter, Christopher R.; Avidan, Michael S.
Critical Care Medicine: April 11, 2022 - Volume -
Issue - 10
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.
