Ignite Creation Date:
2025-12-25 @ 4:11 AM
Ignite Modification Date:
2025-12-26 @ 3:09 AM
Study NCT ID:
NCT05110820
Status:
COMPLETED
Last Update Posted:
2021-11-08
First Post:
2021-10-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Quantitative Assessment of Pupillary Light Reflex in Acute Carbon Monoxide Poisoning
Sponsor:
Wonju Severance Christian Hospital
Organization:
Study Overview
Official Title:
Quantitative Assessment of Pupillary Light Reflex for the Prediction of Neurocognitive Outcomes of Acute Carbon Monoxide Poisoning: A Prospective Observational Study
Status:
COMPLETED
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: