Neurological Sequelae in Patients With Acute Carbon Monoxide Poisoning

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Carbon Monoxide Poisoning
• Intervention / Treatment: Other: No intervention

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.

• Study Type: Observational
• Enrollment (Anticipated): 1250

Contacts and Locations

• Study Contact: Name: Ning Dong, M.D.; Phone Number: +8615804301769; Email: dnjl2007@jlu.edu.cn

Study Locations

• China
  • Jilin
    • Chang chun, Jilin, China, 130000
      • First Hospital of Jilin University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Non-NS ( Non-neurological sequelae) group; Patients who do not develop neurological dysfunction after acute carbon monoxide poisoning	Other: No intervention; No intervention will be given
NS (Neurological sequelae) group; Patients who develop neurological dysfunction after acute carbon monoxide poisoning	Other: No intervention; No intervention will be given

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: The First Hospital of Jilin University
• Investigators: Principal Investigator: Li Pang, M.D., The First Hospital of Jilin University

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2021
• Primary Completion (Anticipated): May 1, 2027
• Study Completion (Anticipated): May 1, 2027

Study Registration Dates

• First Submitted: May 26, 2021
• First Submitted That Met QC Criteria: June 7, 2021
• First Posted (Actual): June 14, 2021

Study Record Updates

• Last Update Posted (Actual): June 14, 2021
• Last Update Submitted That Met QC Criteria: June 7, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: neurological sequelae; carbon monoxide poisoning
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Gas Poisoning; Poisoning; Carbon Monoxide Poisoning
• Other Study ID Numbers: AF-IRB-030-06

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The IPD would be shared with other researcher through e-mail contact with Ning Dong (dnjl2007@jlu.edu.cn)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No