Neurological Sequelae in Patients With Acute Carbon Monoxide Poisoning

Overview

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

Full Title of Study: “The Characteristics of Neurological Sequelae in Patients With Acute Carbon Monoxide Poisoning”

Study Type

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: May 1, 2027

Detailed Description

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.

Interventions

  • Other: No intervention
    • No intervention will be given

Arms, Groups and Cohorts

  • Non-NS ( Non-neurological sequelae) group
    • Patients who do not develop neurological dysfunction after acute carbon monoxide poisoning
  • NS (Neurological sequelae) group
    • Patients who develop neurological dysfunction after acute carbon monoxide poisoning

Clinical Trial Outcome Measures

Primary Measures

  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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
  • 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
  • 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
  • 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
  • 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 Measures

  • 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.
  • 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.

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: 16 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • The First Hospital of Jilin University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Li Pang, M.D., Principal Investigator, The First Hospital of Jilin University
  • Overall Contact(s)
    • Ning Dong, M.D., +8615804301769, dnjl2007@jlu.edu.cn

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