Pupillometry for Pain Assessment in Critically Ill Patients
2015年10月13日 更新者：Claudia Spies、Charite University, Berlin, Germany
This study was part of a quality improvement project at the Department of Anesthesiology and Intensive Care Medicine, Charité - Universitaetsmedizin Berlin.
Being in pain is reported to be one of the most important stressors in critically ill patients and worsens outcome. The evaluation of pain using validated scores in patients who are able to self-report significantly improves the quality of analgesic therapy and health related outcomes in intensive care patients.
However, behavioral pain score that are used in sedated or delirious patients, often underestimate the severity of pain.
The primary aim of this study is to investigate if measurement of the pupillary light reflex Amplitude correlates with the results of pain assessment using validated pain scores in critically ill patients.
研究概览
地位
完全的
条件
研究类型
观察性的
注册 (实际的)
80
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。
学习地点
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Berlin、德国、13353
- Department of Anesthesiology and Intensive Care Medicine CVK/CCM, Charité - University Medicine
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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
Critically ill patients, aged 18 years or older with an expected intensive care unit length of stay of of at least 48 hours.
描述
Inclusion Criteria:
- critically ill patients
- aged 18 years or older
- patients with an expected intensive care unit length of stay of of at least 48 hours.
Exclusion Criteria:
- not German speaking
- traumatic brain injury
- stroke
- increased intracranial pressure
- ocular disease or surgery.
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
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 |
|---|---|---|
|
Correlation coefficient of pupillary light reflex amplitude and pain score
大体时间：Participants will be followed up to 6 days during their intensive care unit stay
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Pain is measured by Numeric Rating Scale - Visualised or Behavioural Pain Scale or Behavioral Pain Scale - Non Intubated and pupillary light reflex amplitude is measured by pupillometry
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Participants will be followed up to 6 days during their intensive care unit stay
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Minimal pupil size [mm]
大体时间：Participants will be followed up to 6 days during their intensive care unit stay
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Participants will be followed up to 6 days during their intensive care unit stay
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Maximal pupil size [mm]
大体时间：Participants will be followed up to 6 days during their intensive care unit stay
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Participants will be followed up to 6 days during their intensive care unit stay
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Contraction speed of pupil [mm/s]
大体时间：Participants will be followed up to 6 days during their intensive care unit stay
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Participants will be followed up to 6 days during their intensive care unit stay
|
|
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Latency of pupil [ms]
大体时间：Participants will be followed up to 6 days during their intensive care unit stay
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Participants will be followed up to 6 days during their intensive care unit stay
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Pupillary light reflex [%]
大体时间：Participants will be followed up to 6 days during their intensive care unit stay
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Participants will be followed up to 6 days during their intensive care unit stay
|
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Richmond Agitation Sedation Scale (RASS)
大体时间：Participants will be followed up to 6 days during their intensive care unit stay
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Participants will be followed up to 6 days during their intensive care unit stay
|
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Glasgow Coma Scale (GCS)
大体时间：Participants will be followed up to 6 days during their intensive care unit stay
|
Participants will be followed up to 6 days during their intensive care unit stay
|
|
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Delirium
大体时间：Participants will be followed up to 6 days during their intensive care unit stay
|
Delirium is measured by the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU)
|
Participants will be followed up to 6 days during their intensive care unit stay
|
|
Duration of mechanical ventilation (hours)
大体时间：Participants will be followed up during their intensive care unit stay, an average of 25 days
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Participants will be followed up during their intensive care unit stay, an average of 25 days
|
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Intensive care unit length of stay (days)
大体时间：Participants will be followed up during their intensive care unit stay, an average of 25 days
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Participants will be followed up during their intensive care unit stay, an average of 25 days
|
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Hospital length of stay (days)
大体时间：Participants will be followed up during their hospital length of stay, an average of 5 weeks
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Participants will be followed up during their hospital length of stay, an average of 5 weeks
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Hospital mortality (days)
大体时间：Participants will be followed up during their hospital length of stay, an average of 5 weeks
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Participants will be followed up during their hospital length of stay, an average of 5 weeks
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Discharge to home [%]
大体时间：Participants will be followed up during their hospital length of stay, an average of 5 weeks
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Participants will be followed up during their hospital length of stay, an average of 5 weeks
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Morbidity Scores
大体时间：Participants will be followed up during their intensive care unit stay, an average of 25 days
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Participants will be followed up during their intensive care unit stay, an average of 25 days
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Amount of administered drugs
大体时间：Participants will be followed up to 6 days during their intensive care unit stay
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Participants will be followed up to 6 days during their intensive care unit stay
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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。
调查人员
- 研究主任：Claudia Spies, MD Prof.、Charité - Univeritätsmedizin Berlin
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
2011年11月1日
初级完成 (实际的)
2012年10月1日
研究完成 (实际的)
2012年10月1日
研究注册日期
首次提交
2015年10月9日
首先提交符合 QC 标准的
2015年10月13日
首次发布 (估计)
2015年10月15日
研究记录更新
最后更新发布 (估计)
2015年10月15日
上次提交的符合 QC 标准的更新
2015年10月13日
最后验证
2015年10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.