Wonju Severance Christian Hospital
Wŏnju, Gangwon-do, 26426, South Korea
NCT Number: NCT04656912
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.
Looking for future studies?
Notify Me16 year and older
All sexes
Observational
Wŏnju, Gangwon-do, 26426, South Korea
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: At 1 month after CO exposure
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.
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
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
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
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
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
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
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
Time frame: At 1 month after CO exposure
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
Time frame: At 6 months after CO exposure
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
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
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
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
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
Wonju Severance Christian Hospital
Other
Effect of Hyperbaric Oxygen Therapy Initiation Time in Acute Carbon Monoxide Poisoning
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05088005
Biomarkers, Carbon Monoxide Poisoning
Wŏnju, Gangwon-do, South Korea
View Trial DetailsNCT06401941
Antioxidants, Hyperbaric Oxygenation
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
View Trial DetailsNCT07659301
Athletic Performance, Hyperbaric Oxygenation
Louvain-la-Neuve, Brabant-Wallon, Belgium
View Trial DetailsNCT07596641
Cardiorespiratory Fitness, Cognition
View Trial Details