NCT04490317

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
117mo left

Started Jul 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress38%
Jul 2020Dec 2035

First Submitted

Initial submission to the registry

July 21, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 29, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

July 29, 2020

Completed
10.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2030

Expected
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2035

Last Updated

July 23, 2024

Status Verified

July 1, 2024

Enrollment Period

10.3 years

First QC Date

July 21, 2020

Last Update Submit

July 22, 2024

Conditions

Carbon Monoxide PoisoningMyocardial InjuryNeurologic DeficitsImage, BodyTherapyPrognostic FactorsComplications

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (38)

  • Therapeutic response to HBO at 12 months

    At 12 months after CO exposure

  • Therapeutic response to TH combined with HBO at 1 month

    At 1 month after CO exposure

  • Therapeutic response to TH combined with HBO at 6 months

    At 6 months after CO exposure

  • Therapeutic response to TH combined with HBO at 12 months

    At 12 months after CO exposure

  • Therapeutic response to HBO according to presence of apolipoprotein E4 at 1 month

    At 1 month after CO exposure

  • +33 more secondary outcomes

Study Arms (1)

Acute CO poisoning

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

Diagnostic Test: Cardiac MRIProcedure: Hyperbaric oxygen therapy

Interventions

Cardiac MRIDIAGNOSTIC_TEST

1. Cardiac MRI be taken to CO poisoned patients 2. Cardiac CT be taken to CO poisoned patients 3. TTE be taken to CO poisoned patients 4. Brain MRI be taken to CO poisoned patients 5. Neurocognitive function tests be taken to CO poisoned patients 6. Laboratory tests be taken to CO poisoned patients

Also known as: Cardiac CT, Transthoracic echocardiography (TTE), Brain MRI, Neurocognitive function tests, Laboratory tests
Acute CO poisoning
Hyperbaric oxygen therapyPROCEDURE

1. Hyperbaric oxygen therapy be used for CO poisoned patients 2. Therapeutic hypothermia be used for CO poisoned patients

Also known as: Therapeutic hypothermia
Acute CO poisoning

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Acute CO poisoning

You may qualify if:

  • Acute CO poisoning

You may not qualify if:

  • Declined to enrollment in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wonju Severance Christian Hospital

Wŏnju, Gangwon-do, 26426, South Korea

RECRUITING

Related Publications (1)

  • Ahn GJ, Lee S, Heo YW, Cha YS. Mortality Risks and Causes in Previous Carbon Monoxide Poisoning: A Nationwide Population-Based Cohort Study. Crit Care Med. 2024 Dec 1;52(12):1866-1876. doi: 10.1097/CCM.0000000000006414. Epub 2024 Sep 18.

    PMID: 39298511DERIVED

MeSH Terms

Conditions

Carbon Monoxide PoisoningNeurologic Manifestations

Interventions

EchocardiographyClinical Laboratory TechniquesHyperbaric OxygenationHypothermia, Induced

Condition Hierarchy (Ancestors)

Gas PoisoningPoisoningChemically-Induced DisordersNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cardiac Imaging TechniquesDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisUltrasonographyHeart Function TestsDiagnostic Techniques, CardiovascularInvestigative TechniquesOxygen Inhalation TherapyRespiratory TherapyTherapeuticsCryotherapy

Study Officials

  • Yong Sung Cha, MD

    Wonju Severance Christian Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yong Sung Cha, MD

CONTACT

+82-33-741-1615emyscha@yonsei.ac.kr

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

July 21, 2020

First Posted

July 29, 2020

Study Start

July 29, 2020

Primary Completion (Estimated)

December 1, 2030

Study Completion (Estimated)

December 1, 2035

Last Updated

July 23, 2024

Record last verified: 2024-07

Locations

KR(1)