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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
1,771
Nurses and physicians will be engaged regarding the clinical outcome data on the importance of ED-based sedation, and the objectives of the research. Education will include in-services and lectures focused on the importance of sedation protocols on patient outcome. The use of sedation will be evaluated throughout the study in order to better understand providers' perception of and experience with ED-based sedation protocols.
Usual care sedation provide in the ED
University of Iowa
Iowa City, Iowa, United States
Washington University School of Medicine/Barnes-Jewish Hospital
St Louis, Missouri, United States
Cooper University Hospital/Cooper Medical School of Rowan University
Camden, New Jersey, United States
Participant Recruitment
Count of eligible participants included in study
Time frame: Through study completion, an average of 1 year
Percentage of Patients With Richmond Agitation-Sedation Scale (RASS) Scores in Deep Sedation Range
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
Time frame: Up to 12 hours (during mechanical ventilation in the emergency department)
Reliability of Richmond Agitation-Sedation Scale (RASS) Measurements During Routine Care in the ED
Interrater correlation coeficient. These were paired observations between study team members and ED nurses. It reflects the degree of agreement between independent observers.
Time frame: Up to 12 hours (during mechanical ventilation in the emergency department)
Number of Participants With Adverse Events
Inadvertent extubation, inadvertent device removal (e.g. central venous catheter, urinary catheter), awareness with paralysis events
Time frame: Up to 12 hours (during mechanical ventilation in the emergency department)
Ventilator-free 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.
Time frame: Up to 28 days
ICU-free 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.
Time frame: Up to 28 days
Hospital-free 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.
Time frame: Up to 28 days
Number of Participants With Delirium
Delirium defined as being CAM-ICU positive as documented by bedside nurse during routine care.
Time frame: Up to 7 days
Mortality
Hospital mortality
Time frame: Up to 28 days, or for the duration of hospitalization
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