The Emergency Department Sedation Pilot Trial

Not Applicable

Completed

Interventions: Behavioral: Education
Other: Standard post intubation sedation practices

Brief 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.

Detailed Description: The ED-SED Pilot is a multicenter, prospective, before-and-after study conducted on 344 mechanically ventilated ED patients at three academic medical centers. Patients in the before phase of the study will receive usual care after the initiation of mechanical ventilation. After 172 patients have been enrolled in the before phase, the investigators will begin educational initiatives to implement ED-based sedation protocols and order sets. The research team will educate providers on the importance of sedation protocols on patient outcome so that the existing protocols begin to be used effectively in the ED. This educational initiative will allow targeted sedation to be effectively used in the ED as well, allowing the intervention to be tested under real-world conditions. Participants in the after phase will also receive standard post-intubation care at the discretion of the treating team, though it will be after the educational initiative aimed at improving post-intubation sedation.

In order to more effectively use sedation in the ED, the investigators will collect voluntary and anonymous surveys from ED nurses and physicians to assess the potential facilitators and barriers to adherence to guideline-recommended sedation.

Recruitment & Eligibility

Inclusion Criteria

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.

Arm && Interventions

Group	Intervention	Description
After group	Education	Mechanically ventilated emergency department patients receiving post-intubation sedation after an educational initiative aimed at improving sedation practices in the ED
Before group	Standard post intubation sedation practices	Mechanically ventilated emergency department patients receiving standard post-intubation sedation prior to an educational initiative on the importance of ED-based targeted sedation

Primary Outcome Measures

Name	Time	Method
Percentage of Patients With Richmond Agitation-Sedation Scale (RASS) Scores in Deep Sedation Range	Up to 12 hours (during mechanical ventilation in the emergency department)	Deep sedation defined as RASS of -3 to -5 Measure of Sedation via RASS. Scale: +4 Combative, +3 Very agitated, +2 Agitated, +1 Restless, 0 Alert and Calm, -1 Drowsy, -2 Light sedation, -3 Moderate sedation, -4 Deep sedation, -5 Unarousable
Reliability of Richmond Agitation-Sedation Scale (RASS) Measurements During Routine Care in the ED	Up to 12 hours (during mechanical ventilation in the emergency department)	Interrater correlation coeficient. These were paired observations between study team members and ED nurses. It reflects the degree of agreement between independent observers.
Number of Participants With Adverse Events	Up to 12 hours (during mechanical ventilation in the emergency department)	Inadvertent extubation, inadvertent device removal (e.g. central venous catheter, urinary catheter), awareness with paralysis events
Participant Recruitment	Through study completion, an average of 1 year	Count of eligible participants included in study

Secondary Outcome Measures

Name	Time	Method
Mortality	Up to 28 days, or for the duration of hospitalization	Hospital mortality
Hospital-free Days	Up to 28 days	To define, hospital-free days equal: 1) 0 if patient dies within 28 days of hospital admission; 2) 28 - x if successfully discharged from the hospital 'x' days after admission to the hospital; or 3) 0 if hospital length of stay exceeds 28 days.
Number of Participants With Delirium	Up to 7 days	Delirium defined as being CAM-ICU positive as documented by bedside nurse during routine care.
Ventilator-free Days	Up to 28 days	To define, ventilator-free days equal: 1) 0 if patient dies within 28 days of mechanical ventilation; 2) 28 - x if successfully liberated from mechanical ventilation 'x' days after intubation; or 3) 0 if mechanical ventilation duration exceeds 28 days.
ICU-free Days	Up to 28 days	To define, ICU-free days equal: 1) 0 if patient dies within 28 days of ICU admission; 2) 28 - x if successfully discharged from the ICU 'x' days after admission to the ICU; or 3) 0 if ICU length of stay exceeds 28 days.

Locations (3): Washington University School of Medicine/Barnes-Jewish Hospital
🇺🇸
Saint Louis, Missouri, United States
University of Iowa
🇺🇸
Iowa City, Iowa, United States
Cooper University Hospital/Cooper Medical School of Rowan University
🇺🇸
Camden, New Jersey, United States