Comparison Between Pupillometry and the Numerical Rating Scale
Comparison Between Pupillometry and the Numerical Rating Scale for the Assessment of Pain in Communicating Adult Patients Presenting to the Emergency Room.
Given the difficulties encountered with subjective pain assessment tools, one of the ideas for reducing the occurrence of insufficient analgesia administration in the emergency department is to find a tool capable of measuring pain without requiring the patient's participation, and which could be integrated into the systematic measurement of the 4 other vitals.
An interesting idea is the measurement of pupillary diameter and its reflex variations by a portable pupillometer.
Indeed, the diameter of the pupil (DP) reflects the constant interactions between the sympathetic and parasympathetic systems at the level of the iris muscles.
Pupillometry measures the change in pupillary diameter and allows the performance of three dynamic tests useful in the assessment of pain.
研究概览
研究类型
介入性
注册 (预期的)
320
阶段
- 不适用
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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Brussel、比利时、1200
- 招聘中
- Cliniques universitaires Saint-Luc
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接触：
- charles gregoire, MD
- 电话号码：0032497534996
- 邮箱：gregoirecharles1@gmail.com
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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
描述
Inclusion Criteria:
- All patients presenting to the emergency room, aged 18 years or over, able to communicate, with hemodynamic and respiratory stability, are eligible.
Exclusion Criteria:
- - Refusal to participate in the study; refusal to sign informed consent.
- Consent impossible to obtain (cognitive disorders, language barrier…).
- Patient taking immediate-release opioid medication (last dose within the last 12 hours).
- Patient taking prolonged-release opioid medication (last dose within the last 24 hours).
- Basic treatment with a dopaminergic D2 antagonist (antipsychotic drugs).
- Basic treatment with dopamine antagonist antiemetic medication (metoclopramide (T1/2 5-6h), domperidone (T1/2 7-9h), alizapride (T1/2 3h)) within the last 12 hours.
- Patient taking clonidine (last dose within the last 24 hours).
- Use of topical ocular drugs modifying pupillary parameters in the last 24 hours.
- Bilateral eye surgery modifying the possibilities of variation in pupillary diameter bilaterally.
- Parkinson's or Alzheimer's disease at a dysautonomic stage.
- Admission to the emergency room for acute ocular pathology.
- History of diabetes at a dysautonomic stage.
- History of alcoholism at a dysautonomic stage.
- History of glaucoma.
- Pregnant patient with preeclampsia.
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
- 主要用途：诊断
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Diagnostic Test: pupillometry
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Step 1: The triage will be carried out by the nurse. The nurse will then perform a self-assessment of the patient's pain using a simple verbal scale. The nurse will then record the patient's self-assessment of his pain using the numeric scale for pain. Step 2: Immediately after this first assessment, eligible patients will be approached by the study investigator to be included in the study. Step 3: If the patient gives informed consent, the study investigator will perform
Step 4: One hour after the triage, a second pain assessment will be performed. Step 5: The same pupillometry measurements will be taken immediately after the nurse has assessed the pain. |
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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The primary outcome will be the correlation between the pupillometry values and those obtained by the numerical pain rating scale with a correlation coefficient of 0.78.
大体时间：1 minute
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1 minute
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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The evolution of the Pupillary Unrest in Ambient Light depending on the type of opioid (morphine versus weak opioid like tramadol) received by the patient.
大体时间：one hour
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one hour
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The endpoint will be the evaluation of the performance of pupillometry to predict the occurrence of Numerical Rating Scale (NRS) ≥ 4 using the ROC curve (AUC).
大体时间：1 minute
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1 minute
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The correlation of the pupillometric parameters with the level of anxiety quantified by a numeric scale next to 1 (not anxious) to 10 (maximum level of anxiety).
大体时间：1 minute
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1 minute
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The correlation between the initial measurement of PUAL and the analgesic response to an opioid medication.
大体时间：one hour
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one hour
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The correlation between the pain measurements obtained by the reception nurse and that obtained by the patient.
大体时间：2 minutes
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2 minutes
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The evolution of the pupillary light reflex depending on the type of opioid (morphine versus weak opioid like tramadol) received by the patient.
大体时间：1 minute
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1 minute
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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。
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 (实际的)
2021年8月4日
初级完成 (预期的)
2022年8月1日
研究完成 (预期的)
2022年8月4日
研究注册日期
首次提交
2021年8月10日
首先提交符合 QC 标准的
2021年8月24日
首次发布 (实际的)
2021年8月25日
研究记录更新
最后更新发布 (实际的)
2021年8月25日
上次提交的符合 QC 标准的更新
2021年8月24日
最后验证
2021年8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.