Carbon Monoxide Poisoning Clinical Trial
Official title:
Effect of Hyperbaric Oxygen Therapy Initiation Time in Acute Carbon Monoxide Poisoning
NCT number | NCT04656912 |
Other study ID # | CO-HBO |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | September 1, 2020 |
Est. completion date | October 30, 2020 |
Verified date | December 2020 |
Source | Wonju Severance Christian Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Hyperbaric oxygen therapy (HBO2) is recommended for symptomatic patients within 24 h of carbon monoxide (CO) poisoning. However, previous major studies found significantly better outcomes with HBO2 in patients treated within 6 h. Currently, there is no consensus on a CO poisoning-to-HBO2 interval that would not be beneficial. Therefore, the investigators aimed to evaluate the difference in therapeutic effect depending on the poisoning-to-HBO2 interval after CO exposure in patients with acute CO poisoning who received HBO2 within 24 h. The investigators compared the neurocognitive outcomes of patients according to HBO2 time intervals based on the outcomes of patients treated within 6 h (control group) with propensity score matching using the CO poisoning registry of our hospital.
Status | Completed |
Enrollment | 706 |
Est. completion date | October 30, 2020 |
Est. primary completion date | October 30, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 16 Years and older |
Eligibility | Inclusion Criteria: - CO poisoned patients Exclusion Criteria: 1. Not treated with HBO2 2. < 16 years old 3. Non-acute CO poisoning 4. Received HBO2 more than 24 h after poisoning 5. A history of previous stroke or neurocognitive diseases 6. Did not undergo follow-up until 6 months 7. Received specific treatment other than HBO2, such as therapeutic hypothermia 8. A history of previous CO exposure 9. A serious illness that can affect the patient's prognosis such as advanced cancer 10. A cardiac arrest before ED arrival 11. No recorded data on important variables, such as time from CO exposure to the start of first HBO2 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Wonju Severance Christian Hospital | Wonju | Gangwon |
Lead Sponsor | Collaborator |
---|---|
Wonju Severance Christian Hospital |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Frequency of poor global deterioration scale (GDS) at 1 month after CO exposure in the overall matched cohort | Frequency of poor GDS (4-7 scores) outcome at 1 month after CO exposure between early group and late group
*GDS (the minimum and maximum: 1-7, higher scores mean a worse outcome) Poor GDS outcome means from 4 to 7 in GDS score. |
At 1 month after CO exposure | |
Primary | Frequency of poor GDS at 6 months after CO exposure in the overall matched cohort | Frequency of poor GDS outcome at 6 months after CO exposure between early group and late group | At 6 months after CO exposure | |
Secondary | Frequency of poor GDS at 1 month after CO exposure between early group and case 1 group in the matched cohort | Frequency of poor GDS outcome at 1 month after CO exposure between early group and case 1 group | At 1 month after CO exposure | |
Secondary | Frequency of poor GDS at 1 month after CO exposure between early group and case 2 group in the matched cohort | Frequency of poor GDS outcome at 1 month after CO exposure between early group and case 2 group | At 1 month after CO exposure | |
Secondary | Frequency of poor GDS at 1 month after CO exposure between case 1 group and case 2 group in the matched cohort | Frequency of poor GDS outcome at 1 month after CO exposure between case 1 group and case 2 group | At 1 month after CO exposure | |
Secondary | Frequency of poor GDS at 6 months after CO exposure between early group and case 1 group in the matched cohort | Frequency of poor GDS outcome at 6 months after CO exposure between early group and case 1 group | At 6 months after CO exposure | |
Secondary | Frequency of poor GDS at 6 months after CO exposure between early group and case 2 group in the matched cohort | Frequency of poor GDS outcome at 6 months after CO exposure between early group and case 2 group | At 6 months after CO exposure | |
Secondary | Frequency of poor GDS at 6 months after CO exposure between case 1 group and case 2 group in the matched cohort | Frequency of poor GDS outcome at 6 months after CO exposure between case 1 group and case 2 group | At 6 months after CO exposure | |
Secondary | The association or trend of change in GDS score at 1 month according to the change of the start time of HBO2 in the overall matched cohort | The association or trend of change in GDS score at 1 month according to the change of the start time of HBO2 in patients treated with HBO2 within 24 h | At 1 month after CO exposure | |
Secondary | The association or trend of change in GDS score at 6 months according to the change of the start time of HBO2 in the overall matched cohort | The association or trend of change in GDS score at 6 months according to the change of the start time of HBO2 in patients treated with HBO2 within 24 h | At 6 months after CO exposure | |
Secondary | Frequency of poor GDS at 1 month after CO exposure in mild CO poisoned patients in the matched cohort | Frequency of poor GDS outcome at 1 month after CO exposure between early group and late group in mild CO poisoned patients | At 1 month after CO exposure | |
Secondary | Frequency of poor GDS at 6 months after CO exposure in mild CO poisoned patients in the matched cohort | Frequency of poor GDS outcome at 6 months after CO exposure between early group and late group in mild CO poisoned patients | At 6 months after CO exposure | |
Secondary | Frequency of poor GDS at 1 month after CO exposure in severe CO poisoned patients in the matched cohort | Frequency of poor GDS outcome at 1 month after CO exposure between early group and late group in severe CO poisoned patients | At 1 month after CO exposure | |
Secondary | Frequency of poor GDS at 6 months after CO exposure in severe CO poisoned patients in the matched cohort | Frequency of poor GDS outcome at 6 months after CO exposure between early group and late group in severe CO poisoned patients | At 6 months after CO exposure |
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