Quantitative Assessment of Pupillary Light Reflex in Acute Carbon Monoxide Poisoning

NCT05110820 | Completed

• 1 other identifier: CO-pupillometer
• Study Type: observational
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

Carbon Monoxide Poisoning

Outcome Measures

Primary Outcomes (4)

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

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

  Within 3 days after acute CO poisoning

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

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

  Within 3 days after acute CO poisoning

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

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

  Within 3 days after acute CO poisoning

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

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

  Within 3 days after acute CO poisoning

Study Arms (1)

Acute CO poisoning

A diagnosis of CO poisoning was made according to medical history and carboxyhaemoglobin \>5% (\>10% in smokers).

Diagnostic Test: Automated quantitative pupillometer

Interventions

Automated quantitative pupillometer DIAGNOSTIC_TEST

Quantitative measurement of pupillary variables was performed at the time of arrival at the ED (0 h), and at the 6-, 12-, and 24-h time points on hospital day (HD) 1. The worst value among those recorded within 24 h and during the total measurement period was selected as the 24-h and total lowest values. If a patient was discharged before HD 3, measurements were taken only until discharge. The initial value was measured within 1 h after arrival at the ED because of the requisite time for obtaining informed consent before enrollment. At each time point, the lowest values for the NPi and qPLR of each eye were retained for analysis. The sPLR (standard PLR) was serially measured in the ED and after admission by emergency physicians using a manual penlight. We classified the reactivity of the sPLR as reactive, sluggish, or non-reactive. Non-reactive sPLR was defined when pupillary reactivity was not identified bilaterally.

Acute CO poisoning

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Acute CO poisoning

You may qualify if:

• Acute CO poisoning

You may not qualify if:

• 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

Sponsors & Collaborators

• Wonju Severance Christian Hospital: lead
• Seoul National University Bundang Hospital: collaborator

Study Sites (1)

Wonju Severance Christian Hospital

Wŏnju, Gangwon-do, 26426, South Korea

Location

MeSH Terms

Conditions

Carbon Monoxide Poisoning

Condition Hierarchy (Ancestors)

Gas Poisoning; Poisoning; Chemically-Induced Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 14, 2021
• First Posted: November 8, 2021
• Study Start: August 1, 2019
• Primary Completion: December 31, 2020
• Study Completion: January 31, 2021
• Last Updated: November 8, 2021

Record last verified: 2021-10

Locations

KR (1)