Neurological Sequelae in Patients With Acute Carbon Monoxide Poisoning

Carbon Monoxide Poisoning Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04925297
• Other study ID #: AF-IRB-030-06
• Status: Not yet recruiting
• Start date: August 1, 2021
• Est. completion date: May 1, 2027

Study information

• Verified date: May 2021
• Source: The First Hospital of Jilin University
• Contact: Ning Dong, M.D.
• Phone: +8615804301769
• Email: dnjl2007[@]jlu.edu.cn
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 1250
• Est. completion date: May 1, 2027
• Est. primary completion date: May 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Carbon Monoxide Poisoning
• Poisoning

Intervention

Other:
• No intervention
No intervention will be given

Locations

Country	Name	City	State
China	First Hospital of Jilin University	Chang chun	Jilin

Sponsors (1)

Lead Sponsor	Collaborator
The First Hospital of Jilin University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of Mini-mental State Examination (MMSE) score at 6 weeks	Score ranges from 0 to 30, a lower score means a worse outcome.	Changes of score from baseline to 6 weeks
Primary	Changes of Mini-mental State Examination (MMSE) score at 6 months	Score ranges from 0 to 30, a lower score means a worse outcome.	Changes of score from baseline to 6 months
Primary	Changes of Mini-mental State Examination (MMSE) score at 12 months	Score ranges from 0 to 30, a lower score means a worse outcome.	Changes of score from baseline to 12 months
Primary	Changes of Montreal cognitive assessment (MoCA)score at 6 weeks	Score ranges from 0 to 30, a lower score means a worse outcome.	Changes of score from baseline to 6 weeks
Primary	Changes of Montreal cognitive assessment (MoCA)score at 6 months	Score ranges from 0 to 30, a lower score means a worse outcome.	Changes of score from baseline to 6 months
Primary	Changes of Montreal cognitive assessment (MoCA)score at 12 months	Score ranges from 0 to 30, a lower score means a worse outcome.	Changes of score from baseline to 12 months
Primary	Changes of Hamilton Depression Scale(HAMD) score at 6 weeks	Score ranges from 0 to 54, a higher score means a worse outcome.	Changes of score from baseline to 6 weeks
Primary	Changes of Hamilton Depression Scale(HAMD) score at 6 months	Score ranges from 0 to 54, a higher score means a worse outcome.	Changes of score from baseline to 6 months
Primary	Changes of Hamilton Depression Scale(HAMD) score at 12 months	Score ranges from 0 to 54, a higher score means a worse outcome.	Changes of score from baseline to 12 months
Primary	Changes of Hamilton Anxiety Scale (HAMA) score at 6 weeks	Score ranges from 0 to 56, a higher score means a worse outcome.	Changes of score from baseline to 6 weeks
Primary	Changes of Hamilton Anxiety Scale (HAMA) score at 6 months	Score ranges from 0 to 56, a higher score means a worse outcome.	Changes of score from baseline to 6 months
Primary	Changes of Hamilton Anxiety Scale (HAMA) score at 12 months	Score ranges from 0 to 56, a higher score means a worse outcome.	Changes of score from baseline to 12 months
Primary	Changes of Activity of Daily Living (ADL) score at 6 weeks	Score ranges from 0 to 80, a higher score means a worse outcome.	Changes of score from baseline to 6 weeks
Primary	Changes of Activity of Daily Living (ADL) score at 6 months	Score ranges from 0 to 80, a higher score means a worse outcome.	Changes of score from baseline to 6 months
Primary	Changes of Activity of Daily Living (ADL) score at 12 months	Score ranges from 0 to 80, a higher score means a worse outcome.	Changes of score from baseline to 12 months
Primary	Changes of self-evaluation of discomfort symptoms scale at 1 week	This is a self designed questionnaire, score ranges from 0 to 66, a higher score means a worse outcome	Changes of score from baseline to 1 week
Primary	Changes of self-evaluation of discomfort symptoms scale at 3 weeks	This is a self designed questionnaire, score ranges from 0 to 66, a higher score means a worse outcome	Changes of score from baseline to 3 weeks
Primary	Changes of self-evaluation of discomfort symptoms scale at 6 weeks	This is a self designed questionnaire, score ranges from 0 to 66, a higher score means a worse outcome	Changes of score from baseline to 6 weeks
Primary	Changes of self-evaluation of discomfort symptoms scale at 6 months	This is a self designed questionnaire, score ranges from 0 to 66, a higher score means a worse outcome	Changes of score from baseline to 6 months
Primary	Changes of self-evaluation of discomfort symptoms scale at 12 months	This is a self designed questionnaire, score ranges from 0 to 66, a higher score means a worse outcome	Changes of score from baseline to 12 months
Secondary	Rates of cardiovascular and cerebrovascular events	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.	through study completion, an average of 1 year
Secondary	Rates of accidental injury	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.	through study completion, an average of 1 year