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临床试验/NCT05110820
NCT05110820已完成不适用

Quantitative Assessment of Pupillary Light Reflex for the Prediction of Neurocognitive Outcomes of Acute Carbon Monoxide Poisoning: A Prospective Observational Study

Wonju Severance Christian Hospital1 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2019年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
104
试验地点
1
主要终点
The prediction of neurological pupil index (NPi) for poor neurocognitive outcome

研究概览

简要总结

Neurological complications after acute carbon monoxide (CO) poisoning can range from transient headache or dizziness to cognitive dysfunction, seizure, permanent anoxic brain damages or death. A recent study reported that a lack of standard pupillary light reflex (sPLR), assessed using a pen light, was a predictor of 30-day neurological sequelae in patients with CO poisoning. Given that the basic sPLR has a poor inter-rater reliability, more objective and quantitative methods are required in the assessment of PLR.

An automated pupillometer has been used in the intensive care unit to quantitatively assess the PLR. Therefore, we hypothesized that quantitative assessment of PLR might be associated with neurocognitive sequelae after acute CO poisoning. The purpose of this study was to assess the value of quantitative pupillary reactivity (NPi and qPLR) in comparison to that of sPLR in predicting neurocognitive outcome at 1 month after acute CO poisoning.

详细描述

Neurological complications after acute carbon monoxide (CO) poisoning can range from transient headache or dizziness to cognitive dysfunction, seizure, permanent anoxic brain damages or death. Although hyperbaric oxygen therapy (HBO2) has been tried to minimize the neurological complications, a significant percentage of patients still suffer from neurocognitive sequelae after acute CO poisoning. A recent study reported that a lack of standard pupillary light reflex (sPLR), assessed using a pen light, was a predictor of 30-day neurological sequelae in patients with CO poisoning. Given that the basic sPLR has a poor inter-rater reliability, more objective and quantitative methods are required in the assessment of PLR.

An automated pupillometer has been used in the intensive care unit to quantitatively assess the PLR. Quantitative PLR (qPLR), which is expressed as the percentage pupillary constriction in response to a calibrated light stimulus, was better in predicting neurological outcome after cardiac arrest (CA) compared to standard light reflex. In addition, the Neurological Pupil index (NPi) has been validated as a tool for assessing prognosis after CA because it is not influenced by medications (especially opioids and neuromuscular blocking agents) or small pupil size.

Therefore, the investigators hypothesized that quantitative assessment of PLR might be associated with neurocognitive sequelae after acute CO poisoning. The purpose of this study was to assess the value of quantitative pupillary reactivity (NPi and qPLR) in comparison to that of sPLR in predicting neurocognitive outcome at 1 month after acute CO poisoning.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Acute CO poisoning

排除标准

  • Age <19 years
  • Patients with a history of ophthalmic surgery which might have affected the PLR
  • Patients with baseline cognitive deficit
  • Refusal to enroll in this study
  • Discharge from the ED or transfer to another hospital within 24 hours
  • Expired in the ED
  • Co-ingestion of drugs, such as hypnotics, that may affect the PLR
  • No follow-up for the neurocognitive outcome

结局指标

主要结局

The prediction of neurological pupil index (NPi) for poor neurocognitive outcome

时间窗: Within 3 days after acute CO poisoning

The predictive value of NPi for the 1-month poor neurocognitive outcome after acute CO poisoning

Comparison of predictive value for poor neurocognitive outcome between NPi and standard pupillary light reflex (sPLR)

时间窗: Within 3 days after acute CO poisoning

The value of NPi in comparison to that of sPLR in predicting neurocognitive outcome at 1 month after acute CO poisoning

Comparison of predictive value for poor neurocognitive outcome between qPLR and sPLR

时间窗: Within 3 days after acute CO poisoning

The value of qPLR in comparison to that of sPLR in predicting neurocognitive outcome at 1 month after acute CO poisoning

The prediction of quantitative pupillary light reflex (qPLR) for poor neurocognitive outcome

时间窗: Within 3 days after acute CO poisoning

The predictive value of qPLR for the 1-month poor neurocognitive outcome after acute CO poisoning

次要结局

未报告次要终点

研究者

发起方
Wonju Severance Christian Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yong Sung Cha

Assistant Professor

Wonju Severance Christian Hospital

研究点 (1)

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