The Characteristics of Neurological Sequelae in Patients With Acute Carbon Monoxide Poisoning
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,250
- 试验地点
- 1
- 主要终点
- Changes of Mini-mental State Examination (MMSE) score at 6 weeks
研究概览
简要总结
The purpose of this study is to access the clinical characteristics and risk factors for neurological sequelae after acute carbon monoxide poisoning.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients present within 12 hours after acute carbon monoxide poisoning;
- •age older than 16 years.
排除标准
- •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)
结局指标
主要结局
Changes of Mini-mental State Examination (MMSE) score at 6 weeks
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
次要结局
- 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)