Instruments for Delirium Assessment Regarding to Analgesia Sedation and Ventilator Status (IDEAS)
2015年12月22日 更新者：Claudia Spies、Charite University, Berlin, Germany
In this prospective, multicenter observational study we assess the diagnostic validity of the following standard screening instruments for delirium regarding sedation, analgesia and ventilator status in critically ill patients:
- Confusion Assessment Method for the ICU (CAM-ICU)
- Intensive Care Delirium Screening Checklist (ICDSC)
- Nursing-Delirium-Screening-Scale (Nu-DESC)
The definite delirium diagnosis (definite in terms of reference standard) is made according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders 4th Edition, text revised (DSM-IV-TR) published by the American Psychiatric Association (APA) which is the Gold Standard to diagnose delirium.
Primary research question: Does sedation, ventilator status and analgesia influence the sensitivity of delirium screening tools (DST)?
研究概览
地位
完全的
条件
研究类型
观察性的
注册 (实际的)
160
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
概率样本
研究人群
Male and female adult critically ill patients
描述
Inclusion Criteria:
- Critically ill patient
- Patient age > 18 years
Exclusion Criteria:
- Neurosurgical patients
- Severe brain injury, intracerebral bleeding, stroke
- Inability to communicate due to anacusia or severe hearing loss
- Insufficient language comprehension
- Patients < 24 h total time of Intensive Care Unit stay
- Deep sedation (RASS < -3) for ≥ 7 days during study participation
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
|---|
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Critically ill patient
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Sensitivity of the delirium screening/diagnosing tool "Confusion Assessment Method for the ICU (CAM-ICU)" regarding sedation and ventilator status.
大体时间：Participants will be followed in the 7-days sample period
|
Used reference standard: DSM-IV TR criteria
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Participants will be followed in the 7-days sample period
|
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Sensitivity of the delirium-screening tool "Intensive-Care Delirium Screening Checklist(ICDSC)" regarding sedation and ventilator status.
大体时间：Participants will be followed in the 7-days sample period
|
Used reference standard: DSM-IV TR criteria.
|
Participants will be followed in the 7-days sample period
|
|
Sensitivity of the delirium screening tool "Nursing Delirium Screening Scale (Nu-DESC)" regarding sedation and ventilator status.
大体时间：Participants will be followed in the 7-days sample period
|
Used reference standard: DSM-IV TR criteria
|
Participants will be followed in the 7-days sample period
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Specificity of the "Confusion Assessment Method for the ICU (CAM-ICU)", the "Intensive Care Delirium Screening Checklist (ICDSC)" and the "Nursing Delirium Screening Scale" regarding sedation and ventilator status.
大体时间：Participants will be followed in the 7-days sample period
|
Used reference standard: DSM-IV-TR criteria.
|
Participants will be followed in the 7-days sample period
|
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Calculation and Analysis of the positive predictive values of the assessed delirium-screening scales.
大体时间：Participants will be followed in the 7-days sample period
|
Calculation of positive and negative predictive values of the "Confusion Assessment Method for the ICU (CAM-ICU)", the "Intensive Care Delirium Screening Checklist (ICDSC)" and the "Nursing Delirium Screening Scale" regarding sedation and ventilator status. Used reference standard: DSM-IV-TR criteria |
Participants will be followed in the 7-days sample period
|
|
Incidence of delirium
大体时间：Participants will be followed in the 7-days sample period
|
According to Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) and Confusion Assessment Method for the ICU (CAM-ICU)
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Participants will be followed in the 7-days sample period
|
|
Incidence of Subsyndromale Delirium (SSD)
大体时间：Participants will be followed in the 7-days sample period
|
According to Intensive Care Delirium Screening Checklist (ICDSC) and Nursing Delirium Screening Scale (Nu-DESC)
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Participants will be followed in the 7-days sample period
|
|
Analgesia
大体时间：Participants will be followed in the 7-days sample period:
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According to Numeric rating scale visually enlarged and laminated (NRS-V), Behavioural pain scale (BPS) and Behavioural pain scale not intubated (BPS-NI)
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Participants will be followed in the 7-days sample period:
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Ventilator status
大体时间：Participants will be followed in the 7-days sample period
|
Clinical observation of A) whether an airway is used B)whether a patient is ventilated with a positive pressure ventilation or a high flow ventilation for more than 6 hours per day.
|
Participants will be followed in the 7-days sample period
|
|
Administered neuroleptics, cumulative
大体时间：Participants will be followed in the 7-days sample period
|
Participants will be followed in the 7-days sample period
|
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Administered analgesics, cumulative
大体时间：Participants will be followed in the 7-days sample period
|
Participants will be followed in the 7-days sample period
|
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Administered sedatives, cumulative
大体时间：Participants will be followed in the 7-days sample period
|
Participants will be followed in the 7-days sample period
|
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Severity of illness
大体时间：Participants will be followed in the 7-days sample period
|
according to Acute Physiology And Chronic Health score (APACHE 2), Simplified Acute Physiology Score (SAPS 2) and Sequential Organ Failure Assessment score (SOFA)
|
Participants will be followed in the 7-days sample period
|
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Antibiotics/infections
大体时间：Participants will be followed in the 7-days sample period
|
Participants will be followed in the 7-days sample period
|
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ICU length of stay
大体时间：Participants will be followed for the duration of intensive care unit stay and hospital stay, an expected average of 4 weeks
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Participants will be followed for the duration of intensive care unit stay and hospital stay, an expected average of 4 weeks
|
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Duration of mechanical ventilation
大体时间：Participants will be followed for the duration of intensive care unit stay and hospital stay, an expected average of 4 weeks
|
Participants will be followed for the duration of intensive care unit stay and hospital stay, an expected average of 4 weeks
|
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Discharge mode
大体时间：Participants will be followed for the duration of intensive care unit stay and hospital stay, an expected average of 4 weeks
|
Participants will be followed for the duration of intensive care unit stay and hospital stay, an expected average of 4 weeks
|
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28-day mortality
大体时间：Participants will be followed for the duration of intensive care unit stay and hospital stay, an expected average of 4 weeks
|
Participants will be followed for the duration of intensive care unit stay and hospital stay, an expected average of 4 weeks
|
|
|
Specificity of the "Confusion Assessment Method for the ICU (CAM-ICU)", the "Intensive Care Delirium Screening Checklist (ICDSC)" and the "Nursing Delirium Screening Scale" regarding analgesia.
大体时间：Participants will be followed in the 7-days sample period
|
Used reference standard: DSM-IV-TR criteria.
|
Participants will be followed in the 7-days sample period
|
|
Sensitivity of the "Confusion Assessment Method for the ICU (CAM-ICU)", the "Intensive Care Delirium Screening Checklist (ICDSC)" and the "Nursing Delirium Screening Scale" regarding analgesia.
大体时间：Participants will be followed in the 7-days sample period
|
Used reference standard: DSM-IV-TR criteria.
|
Participants will be followed in the 7-days sample period
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2012年11月1日
初级完成 (实际的)
2013年12月1日
研究完成 (实际的)
2015年12月1日
研究注册日期
首次提交
2012年10月30日
首先提交符合 QC 标准的
2012年11月1日
首次发布 (估计)
2012年11月2日
研究记录更新
最后更新发布 (估计)
2015年12月23日
上次提交的符合 QC 标准的更新
2015年12月22日
最后验证
2015年12月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.