Hyperbaric Oxygen Therapy Initiation Time in Acute Carbon Monoxide Poisoning
NCT ID: NCT04656912
Last Updated: 2020-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
706 participants
OBSERVATIONAL
2020-09-01
2020-10-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
RETROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Acute CO poisoning
A diagnosis of CO poisoning was made according to medical history and carboxyhemoglobin \>5% (\>10% in smokers).
Hyperbaric oxygen therapy
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Hyperbaric oxygen therapy
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
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
16 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Wonju Severance Christian Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Yong Sung Cha
Assistant Professor
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Wonju Severance Christian Hospital
Wŏnju, Gangwon-do, South Korea
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Lee Y, Cha YS, Kim SH, Kim H. Effect of Hyperbaric Oxygen Therapy Initiation Time in Acute Carbon Monoxide Poisoning. Crit Care Med. 2021 Oct 1;49(10):e910-e919. doi: 10.1097/CCM.0000000000005112.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CO-HBO
Identifier Type: -
Identifier Source: org_study_id