Clinical trial NCT04925297: Neurological Sequelae in Patients With Acute Carbon Monoxide Poisoning
Official title: The Characteristics of Neurological Sequelae in Patients With Acute Carbon Monoxide Poisoning
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Carbon Monoxide Poisoning
Keywords: carbon monoxide poisoning
neurological sequelae
Lead sponsor: The First Hospital of Jilin University
Sponsor class: OTHER
First posted: 2021-06-14
Enrollment: 1250
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All the patients with acute carbon monoxide poisoning would be recruited from the First Hospital of Jilin University.

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.

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)

Primary outcomes:
measure: Changes of Mini-mental State Examination (MMSE) score at 6 weeks
timeFrame: Changes of score from baseline to 6 weeks
measure: Changes of Mini-mental State Examination (MMSE) score at 6 months
timeFrame: Changes of score from baseline to 6 months
measure: Changes of Mini-mental State Examination (MMSE) score at 12 months
timeFrame: Changes of score from baseline to 12 months
measure: Changes of Montreal cognitive assessment (MoCA）score at 6 weeks
timeFrame: Changes of score from baseline to 6 weeks
measure: Changes of Montreal cognitive assessment (MoCA）score at 6 months
timeFrame: Changes of score from baseline to 6 months
measure: Changes of Montreal cognitive assessment (MoCA）score at 12 months
timeFrame: Changes of score from baseline to 12 months
measure: Changes of Hamilton Depression Scale(HAMD) score at 6 weeks
timeFrame: Changes of score from baseline to 6 weeks
measure: Changes of Hamilton Depression Scale(HAMD) score at 6 months
timeFrame: Changes of score from baseline to 6 months
measure: Changes of Hamilton Depression Scale(HAMD) score at 12 months
timeFrame: Changes of score from baseline to 12 months
measure: Changes of Hamilton Anxiety Scale (HAMA) score at 6 weeks
timeFrame: Changes of score from baseline to 6 weeks
measure: Changes of Hamilton Anxiety Scale (HAMA) score at 6 months
timeFrame: Changes of score from baseline to 6 months
measure: Changes of Hamilton Anxiety Scale (HAMA) score at 12 months
timeFrame: Changes of score from baseline to 12 months
measure: Changes of Activity of Daily Living (ADL) score at 6 weeks
timeFrame: Changes of score from baseline to 6 weeks
measure: Changes of Activity of Daily Living (ADL) score at 6 months
timeFrame: Changes of score from baseline to 6 months
measure: Changes of Activity of Daily Living (ADL) score at 12 months
timeFrame: Changes of score from baseline to 12 months
measure: Changes of self-evaluation of discomfort symptoms scale at 1 week
timeFrame: Changes of score from baseline to 1 week
measure: Changes of self-evaluation of discomfort symptoms scale at 3 weeks
timeFrame: Changes of score from baseline to 3 weeks
measure: Changes of self-evaluation of discomfort symptoms scale at 6 weeks
timeFrame: Changes of score from baseline to 6 weeks
measure: Changes of self-evaluation of discomfort symptoms scale at 6 months
timeFrame: Changes of score from baseline to 6 months
measure: Changes of self-evaluation of discomfort symptoms scale at 12 months
timeFrame: Changes of score from baseline to 12 months
Secondary outcomes:
measure: Rates of cardiovascular and cerebrovascular events
timeFrame: through study completion, an average of 1 year
measure: Rates of accidental injury
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Chang chun
country: China
facility: First Hospital of Jilin University
state: Jilin
Study officials:
affiliation: The First Hospital of Jilin University
name: Li Pang, M.D.
role: PRINCIPAL_INVESTIGATOR
References: