Carbon Monoxide PoisoningNCT05110820
Quantitative Assessment of Pupillary Light Reflex in Acute Carbon Monoxide Poisoning
An observational study of Carbon Monoxide Poisoning, run by Wonju Severance Christian Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Carbon Monoxide Poisoning
- What is being tested?
- Automated quantitative pupillometer
- How many people
- 104 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Aug 2019to 31 Jan 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Acute CO poisoning
Who may be able to join
- Acute CO poisoning
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Wonju Severance Christian Hospital
Wŏnju, Gangwon-do, 26426
About this study
Official title: Quantitative Assessment of Pupillary Light Reflex for the Prediction of Neurocognitive Outcomes of Acute Carbon Monoxide Poisoning: A Prospective Observational Study
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.
Read the 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.
- Conditions
- Carbon Monoxide Poisoning
- Being tested
- Automated quantitative pupillometer
- Medical subject headings
- Carbon Monoxide Poisoning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Automated quantitative pupillometerDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Acute CO poisoning | A diagnosis of CO poisoning was made according to medical history and carboxyhaemoglobin >5% (>10% in smokers). Receives: Diagnostic Test: Automated quantitative pupillometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: Within 3 days after acute CO poisoning
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2021
- Study start1 Aug 2019
- Primary completion31 Dec 2020
- Study completion31 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carbon Monoxide PoisoningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wonju Severance Christian Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Seoul National University Bundang Hospital
- Responsible party
- Principal investigator, Yong Sung Cha, Wonju Severance Christian Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05110820
- Sponsor's protocol ID
- CO-pupillometer
- Status last verified
- Oct 2021
- First submitted
- 14 Oct 2021
- Last updated
- 8 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Assessment of Pupillary Light Reflex for the Prediction of Neurocognitive Outcomes of Acute Carbon Monoxide Poisoning: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT05110820
- Acronym / sponsor ID
- CO-pupillometer
- Conditions
- Carbon Monoxide Poisoning
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Wonju Severance Christian HospitalUniversity, hospital or other
- Collaborators
- Seoul National University Bundang Hospital
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Jan 2021 (actual)
- First posted
- 8 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute CO poisoning | – | Diagnostic Test: Automated quantitative pupillometerA diagnosis of CO poisoning was made according to medical history and carboxyhaemoglobin >5% (>10% in smokers). |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Acute CO poisoning
Key inclusion criteria (1 listed)
- Acute CO poisoning
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Automated quantitative pupillometerQuantitative 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. | Diagnostic test | Acute CO poisoning |
Primary outcome
The prediction of neurological pupil index (NPi) for poor neurocognitive outcome
Time frame: Within 3 days after acute CO poisoning
The predictive value of NPi for the 1-month poor neurocognitive outcome after acute CO poisoning
The prediction of quantitative pupillary light reflex (qPLR) for poor neurocognitive outcome
Time frame: Within 3 days after acute CO poisoning
The predictive value of qPLR 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)
Time frame: 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
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carbon Monoxide Poisoning, run by Wonju Severance Christian Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The prediction of neurological pupil index (NPi) for poor neurocognitive outcome (time frame: Within 3 days after acute CO poisoning). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2021.