Efficacy of Self-management of Sedative Therapy by Ventilated ICU Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 161
- 试验地点
- 2
- 主要终点
- Anxiety Rating Using the 100mm Vertical Visual Analog Scale
研究概览
简要总结
The purpose of this randomized clinical trial is to test the efficacy of dexmedetomidine for the self-management of sedative therapy (SMST) in a sample of critically ill patients receiving mechanical ventilator support. The investigators hypothesis is that self-management of sedative therapy by mechanically ventilated patients in the intensive care unit (ICU), tailored to their individual needs will be more efficacious than nurse-administered sedative therapy in reducing anxiety, which may reduce duration of mechanical ventilator support and occurrence of delirium.
详细描述
The overall objective of this study is to demonstrate efficacy for conducting a future, pragmatic effectiveness trial to test whether self-management of sedative therapy (SMST) is superior to nurse-administered sedative therapy in day-to-day intensive care unit (ICU) practice. This efficacy trial is powered for the investigators primary, clinically relevant endpoints (anxiety, duration of mechanical ventilation, and delirium presence), and examines patient outcomes adversely affected by sedative administration practices, such as prolonged ICU stays, altered mental status, and diminished post-ICU quality of life. This randomized clinical trial with a total of 190 mechanically ventilated patients enrolled and maintained on protocol will address the following Specific Aims.
The primary aim is to determine the efficacy of SMST compared to nurse-administered sedative therapy on anxiety, duration of mechanical ventilation, and presence of delirium in mechanically ventilated patients (MVPs).
The secondary aim is to compare level of arousal and sedative exposure in mechanically ventilated patients (MVPs) randomized to SMST to those MVPs receiving nurse-administered sedative therapy. The investigators hypothesize that SMST patients will be easily arousable, more alert, and exposed to less sedation than those who receive nurse-administered sedative therapy.
Exploratory aims are to compare post-ICU outcomes (physical/functional status, psychological well-being, and health-related quality of life) and recall of ICU experiences between MVPs randomized to SMST and those receiving nurse-administered sedative therapy.
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
- 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
- •Subject is acutely mechanically ventilated during the current hospitalization.
- •Subject is currently receiving a continuous intravenous infusion of a sedative/opioid medication(s) or has received at least one intravenous bolus dose of a sedative/opioid medication in the previous 24 hours (fentanyl, hydromorphone, ketamine, morphine, midazolam, diazepam, lorazepam, propofol, haloperidol, dexmedetomidine).
- •Subject must pass pre-Patient-Controlled Sedation (PCS) screening test and be assessed Richmond Agitation-Sedation Scale (RASS) -2 to +1
- •Subject Age ≥ 18 years
- •Subject or their proxy is capable of providing informed consent
排除标准
- •Aggressive ventilatory support or prone ventilation.
- •Hypotension (systolic blood pressure < 85 mmHg) requiring a vasopressor at a dose greater than norepinephrine or epinephrine 0.15 mcg/kg/min or vasopressin > 2.4 units per hour. Subjects will be excluded if they require more than one continuous infusion of a catecholamine vasopressor medication simultaneously. Subjects will be excluded if the vasopressor dose was higher than norepinephrine or epinephrine 0.15 mcg/kg/min, vasopressin > 2.4 units per hour, phenylephrine >3 mcg/kg/min, dopamine >10 mcg/kg/min or dobutamine at any dose in the prior 6 hours. If dopamine is being used to increase heart rate, rather than as a vasopressor for hypotension, subject will be excluded.
- •Second or third degree heart block or bradycardia (heart rate < 50 beats/min).
- •Paralysis or other condition preventing the use of push button device
- •Positive pregnancy test or lactation
- •Acute hepatitis or liver failure (direct bilirubin >5 mg/dL)
- •Acute stroke or uncontrolled seizures.
- •Acute myocardial infarction within 48 hours prior to enrollment.
- •Severe cognition or communication problems (such as coma, deafness without signing literacy, physician-documented dementia)
- •Assessed RASS -3, -4, -5 or RASS +2,+3, +4
- •Chronic ventilator support in place of residence prior to current hospitalization.
- •Imminent extubation from mechanical ventilator support.
研究组 & 干预措施
Dexmedetomidine
These patients will receive a basal intravenous infusion of medication (Dexmedetomidine) and have access to self-administered sedation medication (Dexmedetomidine) for anxiety.
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
Anxiety Rating Using the 100mm Vertical Visual Analog Scale
时间窗: 7 days
Vertical visual analog scale will be used to measure level of state anxiety from 0/zero (no anxiety) to 100 (most anxiety ever). Higher scores mean more anxiety.
Duration of Mechanical Ventilatory Support After Study Enrollment
时间窗: 7 days
Duration of time (hours) patients received mechanical ventilatory support after randomization to either Control or dexmedetomidine self-management of sedative therapy to extubation.
Incidence of Delirium Using the Confusion Assessment Method-ICU (CAM-ICU)
时间窗: 7 days
Confusion Assessment Method-ICU (CAM-ICU) used to assess for the presence (CAM-ICU+) or absence (CAM-ICU-) of delirium at each assessment.
次要结局
- Comparison of Level of Arousal and Agitation Using the Richmond Agitation-Sedation Scale (RASS)(7 days)
- Comparison of Daily Sedation Intensity Each ICU Study Day Using Electronic Health Record Medication Data of Any of Nine Intravenous Sedative Medications Administered to Patients.(Daily Sedation intensity over a 7-day ICU study protocol period)
- Comparison of Daily Sedation Frequency Using Electronic Health Record Medication Data of Any of Nine Intravenous Sedative Medications Administered to Patients.(Daily Sedation Frequency over a 7-day ICU study protocol period)
研究者
Linda L. Chlan, Ph.D., R.N., FAAN
PI
Mayo Clinic