The Emergency Department Sedation Pilot Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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The ED-SED Pilot: a Multicenter, Before-After Study to Improve Sedation in the Emergency Department

Conditions
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Mechanical Ventilation, Respiratory Failure

Intervention / Treatment
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* Behavioral: Education
* Other: Standard post intubation sedation practices


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: This is a prospective, before-and-after study, and there will be no randomization process.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Before group<br>Mechanically ventilated emergency department patients receiving standard post-intubation sedation prior to an educational initiative on the importance of ED-based targeted sedation | Other: Standard post intubation sedation practices<br>* Usual care sedation provide in the ED<br>|
| Other: After group<br>Mechanically ventilated emergency department patients receiving post-intubation sedation after an educational initiative aimed at improving sedation practices in the ED | Behavioral: Education<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participant Recruitment | Count of eligible participants included in study | 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 | 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. | 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 | Up to 12 hours (during mechanical ventilation in the emergency department) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | Up to 28 days | 
| Number of Participants With Delirium | Delirium defined as being CAM-ICU positive as documented by bedside nurse during routine care. | Up to 7 days | 
| Mortality | Hospital mortality | Up to 28 days, or for the duration of hospitalization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sedation, Mechanical Ventilation, Emergency Department, RASS