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Neurological Sequelae in Patients With Acute Carbon Monoxide Poisoning

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04925297
Enrollment
1250
Registered
2021-06-14
Start date
2021-08-01
Completion date
2027-05-01
Last updated
2021-06-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carbon Monoxide Poisoning

Keywords

carbon monoxide poisoning, neurological sequelae

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.

Interventions

OTHERNo intervention

No intervention will be given

Sponsors

The First Hospital of Jilin University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Changes of self-evaluation of discomfort symptoms scale at 12 monthsChanges of score from baseline to 12 monthsThis 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 weeksChanges of score from baseline to 6 weeksThis 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 monthsChanges of score from baseline to 6 monthsThis is a self designed questionnaire, score ranges from 0 to 66, a higher score means a worse outcome
Changes of Activity of Daily Living (ADL) score at 6 monthsChanges of score from baseline to 6 monthsScore ranges from 0 to 80, a higher score means a worse outcome.
Changes of Activity of Daily Living (ADL) score at 12 monthsChanges of score from baseline to 12 monthsScore ranges from 0 to 80, a higher score means a worse outcome.
Changes of Mini-mental State Examination (MMSE) score at 6 weeksChanges of score from baseline to 6 weeksScore ranges from 0 to 30, a lower score means a worse outcome.
Changes of Mini-mental State Examination (MMSE) score at 6 monthsChanges of score from baseline to 6 monthsScore ranges from 0 to 30, a lower score means a worse outcome.
Changes of Mini-mental State Examination (MMSE) score at 12 monthsChanges of score from baseline to 12 monthsScore ranges from 0 to 30, a lower score means a worse outcome.
Changes of Montreal cognitive assessment (MoCA)score at 6 weeksChanges of score from baseline to 6 weeksScore ranges from 0 to 30, a lower score means a worse outcome.
Changes of Montreal cognitive assessment (MoCA)score at 6 monthsChanges of score from baseline to 6 monthsScore ranges from 0 to 30, a lower score means a worse outcome.
Changes of Hamilton Anxiety Scale (HAMA) score at 6 monthsChanges of score from baseline to 6 monthsScore ranges from 0 to 56, a higher score means a worse outcome.
Changes of Hamilton Anxiety Scale (HAMA) score at 12 monthsChanges of score from baseline to 12 monthsScore ranges from 0 to 56, a higher score means a worse outcome.
Changes of Activity of Daily Living (ADL) score at 6 weeksChanges of score from baseline to 6 weeksScore ranges from 0 to 80, a higher score means a worse outcome.
Changes of Montreal cognitive assessment (MoCA)score at 12 monthsChanges of score from baseline to 12 monthsScore ranges from 0 to 30, a lower score means a worse outcome.
Changes of Hamilton Depression Scale(HAMD) score at 6 weeksChanges of score from baseline to 6 weeksScore ranges from 0 to 54, a higher score means a worse outcome.
Changes of Hamilton Depression Scale(HAMD) score at 6 monthsChanges of score from baseline to 6 monthsScore ranges from 0 to 54, a higher score means a worse outcome.
Changes of Hamilton Depression Scale(HAMD) score at 12 monthsChanges of score from baseline to 12 monthsScore ranges from 0 to 54, a higher score means a worse outcome.
Changes of Hamilton Anxiety Scale (HAMA) score at 6 weeksChanges of score from baseline to 6 weeksScore ranges from 0 to 56, a higher score means a worse outcome.
Changes of self-evaluation of discomfort symptoms scale at 1 weekChanges of score from baseline to 1 weekThis 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 weeksChanges of score from baseline to 3 weeksThis is a self designed questionnaire, score ranges from 0 to 66, a higher score means a worse outcome

Secondary

MeasureTime frameDescription
Rates of accidental injurythrough study completion, an average of 1 yearAccidental 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.
Rates of cardiovascular and cerebrovascular eventsthrough study completion, an average of 1 yearCardiovascular 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.

Countries

China

Contacts

Primary ContactNing Dong, M.D.
dnjl2007@jlu.edu.cn+8615804301769

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026