Pain, Agitation and Delirium Protocol in Ventilated Patients in the Duke CICU
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Intensive Care Unit Length of Stay
研究概览
简要总结
This study aims to examine the use of protocol directed sedation using the Duke PAD protocol with the current sedation medications of propofol or dexmedetomidine compared to the PAD protocol with midazolam, per cardiac intensive care unit (CICU) usual care, as an initial step toward understanding the best management of sedation in these patients.
详细描述
The optimal approach to management of sedation in the Intensive Care Unit (ICU) has become a topic of increasing interest. The most recent guidelines outline the pharmacologic mechanisms of commonly used medications as well as scales on which to measure goals of pain, sedation, agitation and delirium in the critically ill patient. This guideline is based on a cadre of randomized controlled trials examining the medications in the medical intensive care unit and post cardiac surgery patient. Notably, in each of the trials, patients presenting with acute myocardial infarction, heart failure or cardiogenic shock have been excluded or largely underrepresented.
Using the current guidelines as a foundation, a new pain, agitation and delirium (PAD) protocol, which prioritizes the use of propofol or dexmedetomidine for sedation, was developed and instituted at Duke University Hospital. However, use of this protocol in the CICU has raised important considerations. Some of these stem from the specific hemodynamic characteristics of the population, including significant bradycardia and hypotension, which can be worsened due to known side effects of propofol and dexmedetomidine. It remains unclear whether the benefits of these medications outweigh the risks in CICU patients as the use of these medications has not been studied previously in this population. This study aims to examine the use of protocol directed sedation using the Duke PAD protocol with the current sedation medications of propofol or dexmedetomidine compared to the PAD protocol with midazolam, per CICU usual care, as an initial step toward understanding the best management of sedation in these patients.
Project Aims Include:
- Examine the efficacy of the PAD protocol using propofol or dexmedetomidine versus midazolam with regard to goal sedation, pain control and level of delirium in intubated Duke CICU patients.
- Determine differences in duration of ventilator days, CICU stay and total hospital stay with the PAD protocol using propofol or dexmedetomidine compared to midazolam in the Duke CICU.
- Compare the rates of adverse effects of the current PAD protocol with propofol or dexmedetomidine versus midazolam for sedation in the Duke CICU, including hypotension, bradycardia, difficulty with ventilator weaning due to sedation, and delirium.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •All patients admitted to the Duke CICU, who require intubation and sedation for mechanical ventilation that is expected to be >24 hours in duration will be included, unless they meet the specified exclusion criteria.
- •Patients intubated within one hour prior to care transition to the CICU will also be screened for inclusion.
排除标准
- •Exclusion criteria include patients following resuscitation from cardiac arrest who are treated on the cooling protocol
- •patients who have suffered a neurologic event (seizure, stroke) or who have baseline dementia, both of which could limit delirium assessment
- •patients with child class B and C liver disease
- •patients with known allergy to study medications.
研究组 & 干预措施
Midazolam
IV midazolam will be administered for sedation while patient is mechanically ventilated. Patient will be monitored per standard of care in the CICU using the Richmond Agitation and Sedation Scale (RASS) with a set goal sedation level of RASS 0 to -2. Pain will be monitored based on the Critical-Care Pain Observation Tool (CPOT) assessment with goal less than or equal to 2. Delirium will be evaluated based on the Confusion Assessment Method for the ICU (CAM-ICU) with goal of negative or patient's baseline.
干预措施: Midazolam (Drug)
Propofol or Dexmedetomidine
Propofol or Dexmedetomidine per physician discretion will be administered for sedation while patient is mechanically ventilated. Patient will be monitored per standard of care in the CICU using the Richmond Agitation and Sedation Scale (RASS) with a set goal sedation level of RASS 0 to -2. Pain will be monitored based on the Critical-Care Pain Observation Tool (CPOT) assessment with goal less than or equal to 2. Delirium will be evaluated based on the Confusion Assessment Method for the ICU (CAM-ICU) with goal of negative or patient's baseline.
干预措施: Propofol (Drug)
Propofol or Dexmedetomidine
Propofol or Dexmedetomidine per physician discretion will be administered for sedation while patient is mechanically ventilated. Patient will be monitored per standard of care in the CICU using the Richmond Agitation and Sedation Scale (RASS) with a set goal sedation level of RASS 0 to -2. Pain will be monitored based on the Critical-Care Pain Observation Tool (CPOT) assessment with goal less than or equal to 2. Delirium will be evaluated based on the Confusion Assessment Method for the ICU (CAM-ICU) with goal of negative or patient's baseline.
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
Intensive Care Unit Length of Stay
时间窗: One month or hospital discharge, whichever time point comes first
Number of days of admission to the CICU during the index hospitalization
次要结局
- Hospital Length of Stay(One month or hospital discharge, whichever time point comes first)
- Number of Participants With Increased Vasopressor Requirement(One month or hospital discharge, whichever time point comes first)
- Number of Participants With Delirium(One month or hospital discharge, whichever time point comes first)
- Number of Ventilator Days(One month or hospital discharge, whichever time point comes first)
- Number of Days From Decision to Extubate to True Extubation(One month or hospital discharge, whichever time point comes first)
- In Hospital Mortality(One month or hospital discharge, whichever time point comes first)
- Pain Management(One month or hospital discharge, whichever time point comes first)
- Number of Participants With Bradycardia(One month or hospital discharge, whichever time point comes first)
- Number of Days Alive During Admission and Free From Delirium or Coma(One month or hospital discharge, whichever time point comes first)
- Percentage of Time at Goal Sedation(One month or hospital discharge, whichever time point comes first)
- Time From Withdrawal of Sedation to ICU Discharge(One month or hospital discharge, whichever time point comes first)
- Number of Participants Requiring Reintubation(One month or hospital discharge, whichever time point comes first)