Neurological Sequelae in Patients With Acute Carbon Monoxide Poisoning
- Conditions
- Carbon Monoxide Poisoning
- Interventions
- Other: No intervention
- Registration Number
- NCT04925297
- Lead Sponsor
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 1250
- patients present within 12 hours after acute carbon monoxide poisoning;
- age older than 16 years.
- 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)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Non-NS ( Non-neurological sequelae) group No intervention Patients who do not develop neurological dysfunction after acute carbon monoxide poisoning NS (Neurological sequelae) group No intervention Patients who develop neurological dysfunction after acute carbon monoxide poisoning
- Primary Outcome Measures
Name Time Method Changes of Mini-mental State Examination (MMSE) score at 6 weeks 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 3 weeks 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 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 6 weeks 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 12 months 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 Outcome Measures
Name Time Method Rates of cardiovascular and cerebrovascular events 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 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.
Trial Locations
- Locations (1)
First Hospital of Jilin University
🇨🇳Chang chun, Jilin, China