Carbon Monoxide PoisoningNCT04925297
Neurological Sequelae in Patients With Acute Carbon Monoxide Poisoning
An observational study of Carbon Monoxide Poisoning, run by The First Hospital of Jilin University at 1 site in China.
Trial summary
The purpose of this study is to access the clinical characteristics and risk factors for neurological sequelae after acute carbon monoxide poisoning. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Carbon Monoxide Poisoning
- How many people
- 1,250 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2021to 1 May 2027
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All the patients with acute carbon monoxide poisoning would be recruited from the First Hospital of Jilin University.
Who may be able to join
- patients present within 12 hours after acute carbon monoxide poisoning;
- age older than 16 years.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Carbon Monoxide Poisoning
- Being tested
- No intervention
- Keywords
- carbon monoxide poisoning, neurological sequelae
- Medical subject headings
- Carbon Monoxide Poisoning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention will be given
| Study group | Role | What they receive |
|---|---|---|
| Non-NS ( Non-neurological sequelae) group | Patients who do not develop neurological dysfunction after acute carbon monoxide poisoning Receives: Other: No intervention | |
| NS (Neurological sequelae) group | Patients who develop neurological dysfunction after acute carbon monoxide poisoning Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of Mini-mental State Examination (MMSE) score at 6 weeks
Score ranges from 0 to 30, a lower score means a worse outcome.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Changes of score from baseline to 12 months
Secondary outcomes (2)
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.
Measured: 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.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2021
- Study start1 Aug 2021 (estimated)
- Primary completion1 May 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carbon Monoxide PoisoningStudies of the same condition, open and under way.
- More trials run by The First Hospital of Jilin UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,250 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- The First Hospital of Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Li Pang, M.D., Principal investigator, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04925297
- Sponsor's protocol ID
- AF-IRB-030-06
- Status last verified
- May 2021
- First submitted
- 26 May 2021
- Last updated
- 14 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The IPD would be shared with other researcher through e-mail contact with Ning Dong (dnjl2007@jlu.edu.cn)
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Characteristics of Neurological Sequelae in Patients With Acute Carbon Monoxide Poisoning
- ClinicalTrials.gov ID
- NCT04925297
- Acronym / sponsor ID
- AF-IRB-030-06
- Conditions
- Carbon Monoxide Poisoning
- Keywords
- carbon monoxide poisoning, neurological sequelae
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,250 participants (estimated)
- Lead sponsor
- The First Hospital of Jilin UniversityUniversity, hospital or other
- Study start
- 1 Aug 2021 (estimated)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 14 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-NS ( Non-neurological sequelae) group | – | Other: No interventionPatients who do not develop neurological dysfunction after acute carbon monoxide poisoning |
| NS (Neurological sequelae) group | – | Other: No interventionPatients who develop neurological dysfunction after acute carbon monoxide poisoning |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All the patients with acute carbon monoxide poisoning would be recruited from the First Hospital of Jilin University.
Key inclusion criteria (2 listed)
- patients present within 12 hours after acute carbon monoxide poisoning;
- age older than 16 years.
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention will be given | Other | NS (Neurological sequelae) group, Non-NS ( Non-neurological sequelae) group |
Primary outcome
Changes of Mini-mental State Examination (MMSE) score at 6 weeks
Time frame: Changes of score from baseline to 6 weeks
Score ranges from 0 to 30, a lower score means a worse outcome.
Changes of Mini-mental State Examination (MMSE) score at 6 months
Time frame: 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
Time frame: 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
Time frame: Changes of score from baseline to 6 weeks
Score ranges from 0 to 30, a lower score means a worse outcome.
Changes of Montreal cognitive assessment (MoCA）score at 6 months
Time frame: 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
Time frame: 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 weeks
Time frame: 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 6 months
Time frame: Changes of score from baseline to 6 months
Score ranges from 0 to 54, a higher score means a worse outcome.
Changes of Hamilton Depression Scale(HAMD) score at 12 months
Time frame: Changes of score from baseline to 12 months
Score ranges from 0 to 54, a higher score means a worse outcome.
Changes of Hamilton Anxiety Scale (HAMA) score at 6 weeks
Time frame: Changes of score from baseline to 6 weeks
Score ranges from 0 to 56, a higher score means a worse outcome.
Changes of Hamilton Anxiety Scale (HAMA) score at 6 months
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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 1 week
Time frame: 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 self-evaluation of discomfort symptoms scale at 3 weeks
Time frame: 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 weeks
Time frame: 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 6 months
Time frame: 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
Time frame: 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
2 secondary outcomes
Rates of cardiovascular and cerebrovascular events
Time frame: through study completion, an average of 1 year
Rates of accidental injury
Time frame: through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2021.
- Individual participant dataSharing planned: Undecided. The IPD would be shared with other researcher through e-mail contact with Ning Dong (dnjl2007@jlu.edu.cn)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Li Pang, M.D. principal investigator
The First Hospital of Jilin University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carbon Monoxide Poisoning, run by The First Hospital of Jilin University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ning Dong, M.D. (+8615804301769, dnjl2007@jlu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of Mini-mental State Examination (MMSE) score at 6 weeks (time frame: Changes of score from baseline to 6 weeks). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2021.