UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054641 |
|---|---|
| Receipt number | R000062440 |
| Scientific Title | Effects of hyperbaric oxygen therapy on patients with carbon monoxide poisoning: A systematic review and meta-analysis |
| Date of disclosure of the study information | 2024/06/12 |
| Last modified on | 2026/02/01 17:38:05 |
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Basic information
Public title
Effects of hyperbaric oxygen therapy on patients with carbon monoxide poisoning: A systematic review and meta-analysis
Acronym
Effects of hyperbaric oxygen therapy on patients with carbon monoxide poisoning: A systematic review and meta-analysis
Scientific Title
Effects of hyperbaric oxygen therapy on patients with carbon monoxide poisoning: A systematic review and meta-analysis
Scientific Title:Acronym
Effects of hyperbaric oxygen therapy on patients with carbon monoxide poisoning: A systematic review and meta-analysis
Region
| Japan |
Condition
Condition
carbon monoxide poisoning
Classification by specialty
| Emergency medicine | Intensive care medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of hyperbaric oxygen therapy in patients with carbon monoxide poisoning. Further, to evaluate the differences in the effects of hyperbaric oxygen therapy at treatment pressures above and below 2.5 absolute atmospheres in patients with carbon monoxide poisoning.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Mortality
Key secondary outcomes
The rate of favorable outcomes, the incidence of delayed neurologic sequelae (DNS), the occurrence of fatal complications, the incidence of neuropsychiatric sequelae, and the occurrence of organ failure (heart, kidneys, liver).
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Randomized controlled trials
2) Adult patients with acute carbon monoxide poisoning
3) Studies comparing hyperbaric oxygen therapy with other types of oxygen therapy (normobaric oxygen therapy)
4) Japanese or English
Key exclusion criteria
Conference abstract
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Motoki |
| Middle name | |
| Last name | Fujita |
Organization
Yamaguchi University Hospital
Division name
Advanced Medical Emergency and Critical Care Center
Zip code
7558505
Address
1-1-1, Minami-Kogushi, Ube, Yamaguchi
TEL
0836222343
motoki99@yamaguchi-u.ac.jp
Public contact
Name of contact person
| 1st name | Motoki |
| Middle name | |
| Last name | Fujita |
Organization
Yamaguchi University Hospital
Division name
Advanced Medical Emergency and Critical Care Center
Zip code
7558505
Address
1-1-1, Minami-Kogushi, Ube, Yamaguchi
TEL
0836222343
Homepage URL
motoki99@yamaguchi-u.ac.jp
Sponsor or person
Institute
Guideline committee of Japan Resuscitation Council (Neuroresuscitation)
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
N/A
Address
N/A
Tel
0836222343
motoki99@yamaguchi-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 06 | Month | 12 | Day |
Related information
URL releasing protocol
none
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/10.1002/ams2.70114
Number of participants that the trial has enrolled
0
Results
From 762 records, 6 RCTs (n=1050) were included. HBO showed no significant benefit vs control (NBO): mortality RR 1.25 (95%CI 0.21-7.34); favorable neuro RR 0.99 (0.79-1.23); DNS RR 0.94 (0.12-7.53); neuropsychiatric RR 0.90 (0.65-1.25). No benefit in >=2.5 ATA subgroup.
Results date posted
| 2026 | Year | 02 | Month | 01 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
This study is a systematic review and meta-analysis and did not enroll new participants. Baseline characteristics are therefore described based on the six included randomized controlled trials (RCTs) conducted between 1989 and 2010 in France, the United States, and Australia (total n=1050). Across trials, participants were adults with acute carbon monoxide poisoning, while eligibility criteria varied by study (e.g., carboxyhemoglobin thresholds such as >=10% in smokers or >=5% in nonsmokers, admission within 6-12 hours after exposure, exclusion of coma, and the presence of loss of consciousness, neurologic symptoms, or metabolic acidosis). HBO intervention protocols ranged from 2.0 to 3.0 ATA with one to multiple sessions (e.g., single 2-hour session, three-session regimen, or daily sessions up to 6 days). Control treatment primarily consisted of normobaric oxygen (e.g., 100% oxygen administration or 1 ATA compressed air), and outcome assessment time points ranged from end of treatment to 1 month, 4 weeks, 6 weeks, 6 months, and 12 months. Overall, clinical populations and treatment protocols were heterogeneous across included trials.
Participant flow
This study is a systematic review and meta-analysis and did not enroll new participants. After identifying records through electronic database searches, duplicates were removed, followed by title/abstract screening and full-text eligibility assessment. Six randomized controlled trials (total n=1050) evaluating HBO therapy for acute carbon monoxide poisoning were ultimately included in the meta-analysis.
Adverse events
Adverse events were not synthesized quantitatively as a pooled meta-analytic outcome in this study. Safety reporting in the included RCTs was heterogeneous, with inconsistent definitions, reporting items, and follow-up periods, which limited standardized aggregation and comparison across trials.
Outcome measures
Outcome measures included the following clinical endpoints:
1. Mortality
2. Favorable neurological outcomes
3. Delayed neurological sequelae (DNS)
4. Neuropsychiatric sequelae
Across outcomes, the HBO group was compared with control (e.g., normobaric oxygen), and pooled effect estimates were summarized primarily using risk ratios (RRs) with 95% confidence intervals. As follow-up time points differed across trials, outcomes were synthesized based on the assessment time points reported in each study. A subgroup analysis by HBO treatment pressure (e.g., >=2.5 ATA) was also performed.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2024 | Year | 06 | Month | 10 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 12 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 13 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2024 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2024 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2024 | Year | 10 | Month | 05 | Day |
Other
Other related information
[Database]
We will use the PubMed, Cochrane Library databases, and ICHUSHI as database.
[Data extraction]
The abstracted data for each study included the first author, year of publication, number of participating institutions, number of patients, age, sex, level of consciousness, CO-Hb levels, method of hyperbaric oxygen therapy administration, incidence of organ failure, incidence of delayed neurologic sequelae or neuropsychiatric sequelae, outcomes including mortality, and complications.
[Risk of bias assessment]
We will assess risk of bias using RoB2.
[Strategy for data synthesis]
We will perform the meta-analysis (random eff ect) using RevMan software.
Management information
Registered date
| 2024 | Year | 06 | Month | 12 | Day |
Last modified on
| 2026 | Year | 02 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062440
