- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04656912
Hyperbaric Oxygen Therapy Initiation Time in Acute Carbon Monoxide Poisoning
Effect of Hyperbaric Oxygen Therapy Initiation Time in Acute Carbon Monoxide Poisoning
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
In the United States, 50,000 patients with carbon monoxide (CO) poisoning are admitted to the hospital emergency departments annually, resulting in 1,500 deaths. CO poisoning can have serious neurologic sequelae. Immediate treatment, within 24 h after poisoning, is a reasonable recommendation for patients with CO poisoning. Most physicians do not treat with hyperbaric oxygen therapy (HBO2) 24 h after CO poisoning.
Weaver et al. conducted a double-blind randomized control trial (RCT) satisfying all Consolidated Standards for the Reporting of Trials guidelines, which showed that HBO2 significantly reduced the rate of cognitive sequelae than normobaric oxygen therapy (NBO2) 6 weeks and 12 months post-treatment in patients with acute symptomatic CO poisoning. Although the aforementioned study used a maximum poisoning-to-HBO2 interval of 24 h in the inclusion criteria, more than 60% of enrolled patients were treated with HBO2 in less than 6 h after CO poisoning and the mean poisoning-to-HBO2 time was 5.8 h. In addition, in a subgroup with poisoning-to-HBO2 interval > 6 h, the mean interval was 8.6 h. Therefore, their study results were actually powered to determine the benefit of HBO2 within 6 h post-CO poisoning; hence, it is unknown whether HBO2 reduces the neurocognitive sequelae occurrence rate if performed beyond 6-12 h from CO poisoning.
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 to make tight adjustments to significant differences in patient baseline characteristics using the CO poisoning registry of our hospital.
The investigators classified the patients included in the study into two groups: an early group (≤ 6 h, control group) and a late group (6-24 h, case group), based on the time from patient rescue from CO source to the start of the first HBO2 session. In addition, patients who received HBO2 at 6-24 h were divided into case 1 group (> 6 h and ≤ 12 h) and case 2 group (≥ 12 h and ≤ 24 h), and outcomes were compared with those of patients who received HBO2 within 6 h from CO exposure. Moreover, the investigators classified poisoning severity based on the necessity for intubation; mildly and severely poisoned patients were defined as those not requiring and requiring intubation, respectively
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Gangwon
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Wonju, Gangwon, Korea, Republic of, 26426
- Wonju Severance Christian Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- CO poisoned patients
Exclusion Criteria:
- Not treated with HBO2
- < 16 years old
- Non-acute CO poisoning
- Received HBO2 more than 24 h after poisoning
- A history of previous stroke or neurocognitive diseases
- Did not undergo follow-up until 6 months
- Received specific treatment other than HBO2, such as therapeutic hypothermia
- A history of previous CO exposure
- A serious illness that can affect the patient's prognosis such as advanced cancer
- A cardiac arrest before ED arrival
- No recorded data on important variables, such as time from CO exposure to the start of first HBO2
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Acute CO poisoning
A diagnosis of CO poisoning was made according to medical history and carboxyhemoglobin >5% (>10% in smokers).
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Patients with any symptoms and signs were treated with HBO2.
During the first HBO2, initial compression was performed to 2.8 atmospheres absolute (ATA) for 45 min, followed by 2.0 ATA for 60 min.
If an additional HBO2 was possible within 24 h, then 2.0 ATA was administered for 90 min.
Moreover, if necessary, patients were treated with HBO2, even after 24 h, until all symptoms resolved.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Frequency of poor global deterioration scale (GDS) at 1 month after CO exposure in the overall matched cohort
Time Frame: At 1 month after CO exposure
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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
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Frequency of poor GDS at 6 months after CO exposure in the overall matched cohort
Time Frame: At 6 months after CO exposure
|
Frequency of poor GDS outcome at 6 months after CO exposure between early group and late group
|
At 6 months after CO exposure
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Frequency of poor GDS at 1 month after CO exposure between early group and case 1 group in the matched cohort
Time Frame: At 1 month after CO exposure
|
Frequency of poor GDS outcome at 1 month after CO exposure between early group and case 1 group
|
At 1 month after CO exposure
|
Frequency of poor GDS at 1 month after CO exposure between early group and case 2 group in the matched cohort
Time Frame: At 1 month after CO exposure
|
Frequency of poor GDS outcome at 1 month after CO exposure between early group and case 2 group
|
At 1 month after CO exposure
|
Frequency of poor GDS at 1 month after CO exposure between case 1 group and case 2 group in the matched cohort
Time Frame: At 1 month after CO exposure
|
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
|
Frequency of poor GDS at 6 months after CO exposure between early group and case 1 group in the matched cohort
Time Frame: At 6 months after CO exposure
|
Frequency of poor GDS outcome at 6 months after CO exposure between early group and case 1 group
|
At 6 months after CO exposure
|
Frequency of poor GDS at 6 months after CO exposure between early group and case 2 group in the matched cohort
Time Frame: At 6 months after CO exposure
|
Frequency of poor GDS outcome at 6 months after CO exposure between early group and case 2 group
|
At 6 months after CO exposure
|
Frequency of poor GDS at 6 months after CO exposure between case 1 group and case 2 group in the matched cohort
Time Frame: At 6 months after CO exposure
|
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
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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
Time Frame: At 1 month after CO exposure
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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
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At 1 month after CO exposure
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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
Time Frame: At 6 months after CO exposure
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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
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Frequency of poor GDS at 1 month after CO exposure in mild CO poisoned patients in the matched cohort
Time Frame: At 1 month after CO exposure
|
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
|
Frequency of poor GDS at 6 months after CO exposure in mild CO poisoned patients in the matched cohort
Time Frame: At 6 months after CO exposure
|
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
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Frequency of poor GDS at 1 month after CO exposure in severe CO poisoned patients in the matched cohort
Time Frame: At 1 month after CO exposure
|
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
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Frequency of poor GDS at 6 months after CO exposure in severe CO poisoned patients in the matched cohort
Time Frame: At 6 months after CO exposure
|
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
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CO-HBO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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