CARbon monoxidE intoxiCatiOn in Korea: Prospective Cohort (CARE CO Cohort)

Study Overview
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Brief Summary
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This prospective cohort study enrolls subjects who experience carbon monoxide (CO) poisoning. The purpose of the study is to evaluate therapeutic effects of various treatments and short and long-term outcomes in CO poisoned patients. In addition, complications of brain and heart susceptible to CO are investigated through various ways and the association between complications and the patient's prognosis is also investigated. All subjects will be regularly monitored by physicians participating in this study.

Detailed Description
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This prospective cohort study enrolls subjects who experience CO poisoning. The purpose of the study is to evaluate therapeutic effects of various treatments, including hyperbaric oxygen therapy (HBO), therapeutic hypothermia (TH), and additional drugs, and short and long-term outcomes, such as neurocognitive sequelae or mortality, in CO poisoned patients. In addition, complications of brain and heart susceptible to CO are investigated through a variety of ways, such as magnetic resonance image (MRI), computed tomography (CT), ultrasound, and laboratory test, and the association between various complications and the patient's prognosis is also investigated. All subjects will be regularly monitored by physicians participating in this study.

Official Title
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CARbon monoxidE intoxiCatiOn in Korea: Prospective Cohort (CARE CO Cohort)

Conditions
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Carbon Monoxide Poisoning, Myocardial Injury, Neurologic Deficits, Image, Body, Therapy, Prognostic Factors, Complications

Intervention / Treatment
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* Diagnostic Test: Cardiac MRI
* Procedure: Hyperbaric oxygen therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Acute CO poisoning Exclusion Criteria: Declined to enrollment in the study
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Acute CO poisoning<br>A diagnosis of CO poisoning is made according to medical history and carboxyhemoglobin >5% (>10% in smokers). | Diagnostic Test: Cardiac MRI<br>* Cardiac MRI be taken to CO poisoned patients Cardiac CT be taken to CO poisoned patients TTE be taken to CO poisoned patients Brain MRI be taken to CO poisoned patients Neurocognitive function tests be taken to CO poisoned patients Laboratory tests be taken to CO poisoned patients<br>* Other names: Laboratory tests;Procedure: Hyperbaric oxygen therapy<br>* Hyperbaric oxygen therapy be used for CO poisoned patients Therapeutic hypothermia be used for CO poisoned patients<br>* Other names: Therapeutic hypothermia;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Therapeutic response to HBO at 1 month | Therapeutic response to HBO according to times from rescue to first HBO and frequency and pressure of HBO at 1 month after CO exposure | At 1 month after CO exposure | 
| Therapeutic response to HBO at 6 months | Therapeutic response to HBO according to times from rescue to first HBO and frequency and pressure of HBO at 6 months after CO exposure | At 6 months after CO exposure | 
| Predictors and model development for participants with poor outcome including mortality, and neurocognitive and psychological sequelae at 1 month after CO exposure evaluated by such as neurocognitive function tests | Predictors and model development for poor outcome including mortality, and neurocognitive and psychological sequelae at 1 month after CO exposure evaluated by tools, such as global deterioration scale (GDS) or Carbon Monoxide Neuropsychological Screening Battery (CONSB), etc, through variables, such as clinical features, laboratory tests, or imaging study that can be investigated within 1 month | Within 1 month after CO exposure | 
| Predictors and model development for participants with poor outcome including mortality, and neurocognitive and psychological sequelae at 6 months after CO exposure evaluated by such as neurocognitive function tests | Predictors and model development for poor outcome including mortality, and neurocognitive and psychological sequelae at 6 months after CO exposure evaluated by tools, such as global deterioration scale (GDS) or Carbon Monoxide Neuropsychological Screening Battery (CONSB), etc, through variables, such as clinical features, laboratory tests, or imaging study that can be investigated within 1 month | Within 1 month after CO exposure | 
| Predictors and model development for participants with poor outcome including mortality, and neurocognitive and psychological sequelae at 12 months after CO exposure evaluated by such as neurocognitive function tests | Predictors and model development for poor outcome including mortality, and neurocognitive and psychological sequelae at 12 months after CO exposure evaluated by tools, such as global deterioration scale (GDS) or Carbon Monoxide Neuropsychological Screening Battery (CONSB), etc, through variables, such as clinical features, laboratory tests, or imaging study that can be investigated within 1 month | Within 1 month after CO exposure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Therapeutic response to HBO at 12 months | Therapeutic response to HBO according to times from rescue to first HBO and frequency and pressure of HBO at 12 months after CO exposure | At 12 months after CO exposure | 
| Therapeutic response to TH combined with HBO at 1 month | Therapeutic response to TH combined with HBO in acute severe CO poisoning at 1 month after CO exposure | At 1 month after CO exposure | 
| Therapeutic response to TH combined with HBO at 6 months | Therapeutic response to TH combined with HBO in acute severe CO poisoning at 6 months after CO exposure | At 6 months after CO exposure | 
| Therapeutic response to TH combined with HBO at 12 months | Therapeutic response to TH combined with HBO in acute severe CO poisoning at 12 months after CO exposure | At 12 months after CO exposure | 
| Therapeutic response to HBO according to presence of apolipoprotein E4 at 1 month | Therapeutic response to HBO according to presence of apolipoprotein E4 genotype at 1 month after CO exposure | At 1 month after CO exposure | 
| Therapeutic response to HBO according to presence of apolipoprotein E4 at 6 months | Therapeutic response to HBO according to presence of apolipoprotein E4 genotype at 6 months after CO exposure | At 6 months after CO exposure | 
| Therapeutic response to HBO according to presence of apolipoprotein E4 at 12 months after CO exposure | Therapeutic response to HBO according to presence of apolipoprotein E4 genotype at 12 months after CO exposure | At 12 months after CO exposure | 
| Cardiac injury evaluated by cardiac MRI in acute phase | Cardiac injury related to CO poisoning evaluated by cardiac MRI in acute phase | Within 1 month after CO exposure | 
| Cardiac injury evaluated by cardiac MRI in chronic phase | Cardiac injury related to CO poisoning evaluated by cardiac MRI in chronic phase | Follow-up cardiac MRI (at 4-8 months after CO exposure) | 
| Cardiac injury evaluated by cardiac CT | Cardiac injury evaluated by cardiac CT in CO poisoning | Within 1 month after CO exposure | 
| Cardiac injury evaluated by TTE in acute phase | Cardiac injury related to CO poisoning evaluated by TTE in acute phase | Within 14 days after CO exposure | 
| Cardiac injury evaluated by TTE in chronic phase | Cardiac injury related to CO poisoning evaluated by TTE in chronic phase | Within 4-8 months after CO exposure | 
| Brain injury evaluated by brain imaging modality related to CO poisoning | Brain injury evaluated by brain MRI in CO poisoning | Within 6 months after CO exposure | 
| Brain injury related to CO poisoning | Brain injury evaluated by laboratory tests in CO poisoning | Within 6 months after CO exposure | 
| Association between presence of cardiac injury, which is evaluated by cardiac enzyme or cardiac imaging studies, and poor outcome including mortality, and neurocognitive and psychological sequelae at 1 month after CO exposure | Association between presence of cardiac injury, which is evaluated by electrocardiogram, cardiac enzyme, or cardiac imaging studies, and poor outcome including mortality, and neurocognitive and psychological sequelae at 1 month after CO exposure | Outcomes at 1 month after CO exposure | 
| Association between presence of cardiac injury, which is evaluated by cardiac enzyme or cardiac imaging studies, and poor outcome including mortality, and neurocognitive and psychological sequelae at 6 months after CO exposure | Association between presence of cardiac injury, which is evaluated by electrocardiogram, cardiac enzyme, or cardiac imaging studies, and poor outcome including mortality, and neurocognitive and psychological sequelae at 6 months after CO exposure | Outcomes at 6 months after CO exposure | 
| Association between presence of cardiac injury, which is evaluated by cardiac enzyme or cardiac imaging studies, and poor outcome including mortality, and neurocognitive and psychological sequelae at 12 months after CO exposure | Association between presence of cardiac injury, which is evaluated by electrocardiogram, cardiac enzyme, or cardiac imaging studies, and poor outcome including mortality, and neurocognitive and psychological sequelae at 12 months after CO exposure | Outcomes at 12 months after CO exposure | 
| Association between presence of cardiac injury, which is evaluated by cardiac enzyme or cardiac imaging studies, and poor outcome including mortality, and neurocognitive and psychological sequelae at 5 years after CO exposure | Association between presence of cardiac injury, which is evaluated by electrocardiogram, cardiac enzyme, or cardiac imaging studies, and poor outcome including mortality, and neurocognitive and psychological sequelae at 5 years after CO exposure | Outcomes at 5 years after CO exposure | 
| Association between presence of brain injury, which is evaluated by brain imaging studies, and poor outcome including mortality, and neurocognitive and psychological sequelae at 1 month after CO exposure evaluated by neurocognitive function tests | Association between presence of brain injury, which is evaluated by brain MRI, etc, and poor outcome including mortality, and neurocognitive and psychological sequelae at 1 month after CO exposure evaluated by such as GDS or CONSB, etc | Outcomes at 1 month after CO exposure | 
| Association between presence of brain injury, which is evaluated by brain imaging studies, and poor outcome including mortality, and neurocognitive and psychological sequelae at 6 months after CO exposure evaluated by neurocognitive function tests | Association between presence of brain injury, which is evaluated by brain MRI, etc, and poor outcome including mortality, and neurocognitive and psychological sequelae at 6 months after CO exposure evaluated by such as GDS or CONSB, etc | Outcomes at 6 months after CO exposure | 
| Association between presence of brain injury, which is evaluated by brain imaging studies, and poor outcome including mortality, and neurocognitive and psychological sequelae at 12 months after CO exposure evaluated by neurocognitive function tests | Association between presence of brain injury, which is evaluated by brain MRI, etc, and poor outcome including mortality, and neurocognitive and psychological sequelae at 12 months after CO exposure evaluated by such as GDS or CONSB, etc | Outcomes at 12 months after CO exposure | 
| Association between presence of brain injury, which is evaluated by brain imaging studies, and poor outcome including mortality, and neurocognitive and psychological sequelae at 5 years after CO exposure evaluated by neurocognitive function tests | Association between presence of brain injury, which is evaluated by brain MRI, etc, and poor outcome including mortality, and neurocognitive and psychological sequelae at 5 years after CO exposure evaluated by such as GDS or CONSB, etc | Outcomes at 5 years after CO exposure | 
| Association between presence of brain injury, which is evaluated by laboratory tests, and poor outcome including mortality, and neurocognitive and psychological sequelae at 1 month after CO exposure evaluated by neurocognitive function tests | Association between presence of brain injury, which is evaluated by laboratory tests, etc, and poor outcome including mortality, and neurocognitive and psychological sequelae at 1 month after CO exposure evaluated by such as GDS or CONSB, etc | Outcomes at 1 month after CO exposure | 
| Association between presence of brain injury, which is evaluated by laboratory tests, and poor outcome including mortality, and neurocognitive and psychological sequelae at 6 months after CO exposure evaluated by neurocognitive function tests | Association between presence of brain injury, which is evaluated by laboratory tests, etc, and poor outcome including mortality, and neurocognitive and psychological sequelae at 6 months after CO exposure evaluated by such as GDS or CONSB, etc | Outcomes at 6 months after CO exposure | 
| Association between presence of brain injury, which is evaluated by laboratory tests, and poor outcome including mortality, and neurocognitive and psychological sequelae at 12 months after CO exposure evaluated by neurocognitive function tests | Association between presence of brain injury, which is evaluated by laboratory tests, etc, and poor outcome including mortality, and neurocognitive and psychological sequelae at 12 months after CO exposure evaluated by such as GDS or CONSB, etc | Outcomes at 12 months after CO exposure | 
| Association between presence of brain injury, which is evaluated by laboratory tests, and poor outcome including mortality, and neurocognitive and psychological sequelae at 5 years after CO exposure evaluated by neurocognitive function tests | Association between presence of brain injury, which is evaluated by laboratory tests, etc, and poor outcome including mortality, and neurocognitive and psychological sequelae at 5 years after CO exposure evaluated by such as GDS or CONSB, etc | Outcomes at 5 years after CO exposure | 
| Therapeutic response to drugs at 1 month | Therapeutic response to additional drug including steroid at 1 month after CO exposure | At 1 month after CO exposure | 
| Therapeutic response to drugs at 6 months | Therapeutic response to additional drug including steroid at 6 months after CO exposure | At 6 months after CO exposure | 
| Therapeutic response to drugs at 12 months | Therapeutic response to additional drug including steroid at 12 months after CO exposure | At 12 months after CO exposure | 
| Prevalence of poor outcomes including mortality, and neurocognitive and psychological sequelae after CO poisoning at 1 month | Prevalence of poor outcomes including mortality, and neurocognitive and psychological sequelae evaluated by, such as GDS or CONSB, etc, after CO poisoning at 1 month after CO exposure | At 1 month after CO exposure | 
| Prevalence of poor outcomes including mortality, and neurocognitive and psychological sequelae after CO poisoning at 6 months | Prevalence of poor outcomes including mortality, and neurocognitive and psychological sequelae evaluated by, such as GDS or CONSB, etc, after CO poisoning at 6 months after CO exposure | At 6 months after CO exposure | 
| Prevalence of poor outcomes including mortality, and neurocognitive and psychological sequelae after CO poisoning at 12 months | Prevalence of poor outcomes including mortality, and neurocognitive and psychological sequelae evaluated by, such as GDS or CONSB, etc, after CO poisoning at 12 months after CO exposure | At 12 months after CO exposure | 
| Prevalence of poor outcomes including mortality, and neurocognitive and psychological sequelae after CO poisoning at 5 years | Prevalence of poor outcomes including mortality, and neurocognitive and psychological sequelae evaluated by, such as GDS or CONSB, etc, after CO poisoning at 5 years after CO exposure | At 5 years after CO exposure | 
| Organ injury related to CO poisoning | Organ injury, such as lung, kidney, liver, pancreas, or bowel, etc, related to CO poisoning | Within 6 months after CO exposure | 
| Complications related to CO poisoning | Complications, such as pulmonary thromboembolism or rhabdomyolysis, etc, related to CO poisoning | Within 6 months after CO exposure | 
| Effect of HBO for delayed neurocognitive and psychological dysfunction at 1 year after onset | Effect of HBO for patient with delayed neurocognitive and psychological sequelae at 1 year after sequelae onset | Within 1 year after delayed neurocognitive and psychological sequelae onset | 
| Effect of HBO for delayed neurocognitive and psychological dysfunction at 2 years after onset | Effect of HBO for patient with delayed neurocognitive and psychological sequelae at 2 years after sequelae onset | Within 2 years after delayed neurocognitive and psychological sequelae onset | 
| Validation of methods evaluating neurocognitive and psychological outcomes | Validation of methods evaluating neurocognitive and psychological outcomes within 6 months | Within 6 months after CO exposure |