N/A
N=1,771
The Emergency Department Sedation Pilot Trial
Mechanical Ventilation · Respiratory Failure
Bottom Line
View on ClinicalTrials.gov: NCT04410783 ↗Enrolled (actual)
1,771
Serious AEs
4.6%
Results posted
Dec 2022
Primary outcome: Primary: Participant Recruitment — 196; 219 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Education (Behavioral); Standard post intubation sedation practices (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Washington University School of Medicine
- Primary completion
- May 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participant Recruitment |
196; 219 | — |
| PRIMARY Percentage of Patients With Richmond Agitation-Sedation Scale (RASS) Scores in Deep Sedation Range |
118; 85 | — |
| PRIMARY Reliability of Richmond Agitation-Sedation Scale (RASS) Measurements During Routine Care in the ED |
0.88 | — |
| PRIMARY Number of Participants With Adverse Events |
8; 11 | — |
| SECONDARY Ventilator-free Days |
19.9; 22.0 | — |
| SECONDARY ICU-free Days |
18.1; 20.8 | — |
| SECONDARY Hospital-free Days |
14.3; 15.2 | — |
| SECONDARY Number of Participants With Delirium |
63; 62 | — |
| SECONDARY Mortality |
40; 22 | — |
Summary
The ED-SED Pilot is a multicenter, prospective, before-and-after study conducted on 344 mechanically ventilated emergency department patients at three academic medical centers: Washington University in St. Louis School of Medicine (St. Louis, MO), Cooper Hospital of Rowan University (Camden, NJ), and University of Iowa Carver College of Medicine (Iowa City, IA). The overall goal is to assess the feasibility of implementing targeted sedation (in terms of sedation depth) for mechanically ventilated ED patients in order to reduce the incidence of unnecessary deep sedation and improve clinical outcomes.
Eligibility Criteria
Inclusion Criteria
- Mechanical ventilation via an endotracheal tube.
- Age ≥ 18 years.
Exclusion Criteria
- Acute neurologic injury (stroke, intracranial hemorrhage, traumatic brain injury, cardiac arrest, status epilepticus, fulminant hepatic failure).
- Ongoing neuromuscular blockade.
- Death or transition to comfort measures within 24 hours.
- Transfer to another hospital from the ED.
- Chronic/home mechanical ventilation.
- Transfer directly from the ED to the operating room.
Data sourced from ClinicalTrials.gov (NCT04410783). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.