The ED-SED Pilot: a Multicenter, Before-After Study to Improve Sedation in the Emergency Department
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,771
- 试验地点
- 3
- 主要终点
- Percentage of Patients With Richmond Agitation-Sedation Scale (RASS) Scores in Deep Sedation Range
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mechanical ventilation via an endotracheal tube.
- •Age ≥ 18 years.
排除标准
- •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.
研究组 & 干预措施
Before group
Mechanically ventilated emergency department patients receiving standard post-intubation sedation prior to an educational initiative on the importance of ED-based targeted sedation
干预措施: Standard post intubation sedation practices (Other)
After group
Mechanically ventilated emergency department patients receiving post-intubation sedation after an educational initiative aimed at improving sedation practices in the ED
干预措施: Education (Behavioral)
结局指标
主要结局
Percentage of Patients With Richmond Agitation-Sedation Scale (RASS) Scores in Deep Sedation Range
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: Through study completion, an average of 1 year
Count of eligible participants included in study
次要结局
- Mortality(Up to 28 days, or for the duration of hospitalization)
- Hospital-free Days(Up to 28 days)
- Number of Participants With Delirium(Up to 7 days)
- Ventilator-free Days(Up to 28 days)
- ICU-free Days(Up to 28 days)
研究者
Brian Fuller
Associate Professor of Anesthesiology and Emergency Medicine
Washington University School of Medicine