Skip to main content
Clinical Trials/NCT04925297
NCT04925297
Not yet recruiting
Not Applicable

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

The First Hospital of Jilin University1 site in 1 country1,250 target enrollmentAugust 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Carbon Monoxide Poisoning
Sponsor
The First Hospital of Jilin University
Enrollment
1250
Locations
1
Primary Endpoint
Changes of Mini-mental State Examination (MMSE) score at 6 weeks
Status
Not yet recruiting
Last Updated
4 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
August 1, 2021
End Date
May 1, 2027
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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)

Outcomes

Primary Outcomes

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 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 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 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 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 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 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 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 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 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 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 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 Outcomes

  • Rates of cardiovascular and cerebrovascular events(through study completion, an average of 1 year)
  • Rates of accidental injury(through study completion, an average of 1 year)

Study Sites (1)

Loading locations...

Similar Trials