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NCT Number: NCT04925297

Neurological Sequelae in Patients With Acute Carbon Monoxide Poisoning

The purpose of this study is to access the clinical characteristics and risk factors for neurological sequelae after acute carbon monoxide poisoning.

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Key information

Conditions

Carbon Monoxide Poisoning Chemically-Induced Disorders Gas Poisoning Poisoning

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

First Hospital of Jilin University

Changchun, Jilin, 130000, China

About this study

After being informed about the study and potential risks, patients meet the inclusion criteria would be given informed consent and entry the study. The data will be collected according to self-designed questionnaire, including :1) The baseline characteristics: would be recorded 6 hours after patients presentation;2) Patients' self evaluation for discomfort symptoms: would be recorded at day 0, week 1, 3 and 6, month 6 and 12；3) Neurological function: would be recorded at day 0, week 6, month 6 and 12.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients present within 12 hours after acute carbon monoxide poisoning;
  • age older than 16 years.

Exclusion criteria

  • pregnant women；
  • patients receive oxygen therapy before presentation;
  • have history of acute carbon monoxide poisoning within 1 year;
  • have been diagnosed any of the following disease: Parkinson disease; cognitive disorder, psychiatric disorders, sequelae of cerebral infarction or hemorrhage, chronic kidney disease and receive hemodialysis, congestive heart failure ( NYHA class III-IV)

Treatment and study plan

No intervention

Other

No intervention will be given

Primary outcomes

  1. Changes of Mini-mental State Examination (MMSE) score at 6 weeks

    Time frame: Changes of score from baseline to 6 weeks

    Score ranges from 0 to 30, a lower score means a worse outcome.

  2. Changes of Mini-mental State Examination (MMSE) score at 6 months

    Time frame: Changes of score from baseline to 6 months

    Score ranges from 0 to 30, a lower score means a worse outcome.

  3. Changes of Mini-mental State Examination (MMSE) score at 12 months

    Time frame: Changes of score from baseline to 12 months

    Score ranges from 0 to 30, a lower score means a worse outcome.

  4. Changes of Montreal cognitive assessment (MoCA）score at 6 weeks

    Time frame: Changes of score from baseline to 6 weeks

    Score ranges from 0 to 30, a lower score means a worse outcome.

  5. Changes of Montreal cognitive assessment (MoCA）score at 6 months

    Time frame: Changes of score from baseline to 6 months

    Score ranges from 0 to 30, a lower score means a worse outcome.

  6. Changes of Montreal cognitive assessment (MoCA）score at 12 months

    Time frame: Changes of score from baseline to 12 months

    Score ranges from 0 to 30, a lower score means a worse outcome.

  7. Changes of Hamilton Depression Scale(HAMD) score at 6 weeks

    Time frame: Changes of score from baseline to 6 weeks

    Score ranges from 0 to 54, a higher score means a worse outcome.

  8. Changes of Hamilton Depression Scale(HAMD) score at 6 months

    Time frame: Changes of score from baseline to 6 months

    Score ranges from 0 to 54, a higher score means a worse outcome.

  9. Changes of Hamilton Depression Scale(HAMD) score at 12 months

    Time frame: Changes of score from baseline to 12 months

    Score ranges from 0 to 54, a higher score means a worse outcome.

  10. Changes of Hamilton Anxiety Scale (HAMA) score at 6 weeks

    Time frame: Changes of score from baseline to 6 weeks

    Score ranges from 0 to 56, a higher score means a worse outcome.

  11. Changes of Hamilton Anxiety Scale (HAMA) score at 6 months

    Time frame: Changes of score from baseline to 6 months

    Score ranges from 0 to 56, a higher score means a worse outcome.

  12. Changes of Hamilton Anxiety Scale (HAMA) score at 12 months

    Time frame: Changes of score from baseline to 12 months

    Score ranges from 0 to 56, a higher score means a worse outcome.

  13. Changes of Activity of Daily Living (ADL) score at 6 weeks

    Time frame: Changes of score from baseline to 6 weeks

    Score ranges from 0 to 80, a higher score means a worse outcome.

  14. Changes of Activity of Daily Living (ADL) score at 6 months

    Time frame: Changes of score from baseline to 6 months

    Score ranges from 0 to 80, a higher score means a worse outcome.

  15. Changes of Activity of Daily Living (ADL) score at 12 months

    Time frame: Changes of score from baseline to 12 months

    Score ranges from 0 to 80, a higher score means a worse outcome.

  16. Changes of self-evaluation of discomfort symptoms scale at 1 week

    Time frame: Changes of score from baseline to 1 week

    This is a self designed questionnaire, score ranges from 0 to 66, a higher score means a worse outcome

  17. Changes of self-evaluation of discomfort symptoms scale at 3 weeks

    Time frame: Changes of score from baseline to 3 weeks

    This is a self designed questionnaire, score ranges from 0 to 66, a higher score means a worse outcome

  18. Changes of self-evaluation of discomfort symptoms scale at 6 weeks

    Time frame: Changes of score from baseline to 6 weeks

    This is a self designed questionnaire, score ranges from 0 to 66, a higher score means a worse outcome

  19. Changes of self-evaluation of discomfort symptoms scale at 6 months

    Time frame: Changes of score from baseline to 6 months

    This is a self designed questionnaire, score ranges from 0 to 66, a higher score means a worse outcome

  20. Changes of self-evaluation of discomfort symptoms scale at 12 months

    Time frame: Changes of score from baseline to 12 months

    This is a self designed questionnaire, score ranges from 0 to 66, a higher score means a worse outcome

Secondary outcomes

  1. Rates of cardiovascular and cerebrovascular events

    Time frame: through study completion, an average of 1 year

    Cardiovascular and cerebrovascular events includes：cardiac arrest, myocardial infarction, cerebral hemorrhage, and cerebral infarction. A patient develops any of the former diseases during following up would be record as 1 event.

  2. Rates of accidental injury

    Time frame: through study completion, an average of 1 year

    Accidental injuries may include accidental fall, fracture, traffic accident etc. A patient develops any of the former during following up would be record as 1 event.

Study contacts

Contact information is provided by the study sponsor or research team.

Ning Dong, M.D.

CONTACT

[email protected]

+8615804301769

Sponsors and collaborators

Lead sponsor

The First Hospital of Jilin University

Other

Registry information

Official study title

The Characteristics of Neurological Sequelae in Patients With Acute Carbon Monoxide Poisoning

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Jun 14, 2021
Registry last updated
Jun 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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