Hyperbaric OxygenationNCT04656912
Hyperbaric Oxygen Therapy Initiation Time in Acute Carbon Monoxide Poisoning
An observational study of Hyperbaric Oxygenation and Carbon Monoxide Poisoning, run by Wonju Severance Christian Hospital at 1 site in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Hyperbaric Oxygenation, Carbon Monoxide Poisoning, Time
- What is being tested?
- Hyperbaric oxygen therapy
- Type of treatment
- Surgery or procedure
- How many people
- 706 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Sep 2020to 30 Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: CO poisoned patients
Who may be able to join
- CO poisoned patients
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Wonju Severance Christian Hospital
Wŏnju, Gangwon-do, 26426
About this study
Official title: 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.
Read the 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
- Conditions
- Hyperbaric Oxygenation, Carbon Monoxide Poisoning, Time
- Being tested
- Hyperbaric oxygen therapy
- Medical subject headings
- Carbon Monoxide Poisoning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperbaric oxygen therapyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Acute CO poisoning | A diagnosis of CO poisoning was made according to medical history and carboxyhemoglobin >5% (>10% in smokers). Receives: Procedure: Hyperbaric oxygen therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 1 month after CO exposure
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
Measured: At 6 months after CO exposure
Secondary outcomes (12)
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
Measured: 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
Frequency of poor GDS outcome at 1 month after CO exposure between early group and case 2 group
Measured: 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
Frequency of poor GDS outcome at 1 month after CO exposure between case 1 group and case 2 group
Measured: 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
Frequency of poor GDS outcome at 6 months after CO exposure between early group and case 1 group
Measured: 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
Frequency of poor GDS outcome at 6 months after CO exposure between early group and case 2 group
Measured: 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
Frequency of poor GDS outcome at 6 months after CO exposure between case 1 group and case 2 group
Measured: At 6 months 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 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
Measured: At 1 month 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 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
Measured: At 6 months after CO exposure
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
Measured: 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
Frequency of poor GDS outcome at 6 months after CO exposure between early group and late group in mild CO poisoned patients
Measured: At 6 months after CO exposure
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
Measured: At 1 month after CO exposure
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
Measured: At 6 months after CO exposure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2020
- Study start1 Sep 2020
- Primary completion30 Oct 2020
- Study completion30 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hyperbaric OxygenationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 706 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wonju Severance Christian Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yong Sung Cha, Wonju Severance Christian Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04656912
- Sponsor's protocol ID
- CO-HBO
- Status last verified
- Dec 2020
- First submitted
- 30 Nov 2020
- Last updated
- 29 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34074856
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Hyperbaric Oxygen Therapy Initiation Time in Acute Carbon Monoxide Poisoning
- ClinicalTrials.gov ID
- NCT04656912
- Acronym / sponsor ID
- CO-HBO
- Conditions
- Hyperbaric Oxygenation, Carbon Monoxide Poisoning, Time
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 706 participants (actual)
- Lead sponsor
- Wonju Severance Christian HospitalUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 30 Oct 2020 (actual)
- Study completion
- 30 Oct 2020 (actual)
- First posted
- 7 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute CO poisoning | – | Procedure: Hyperbaric oxygen therapyA diagnosis of CO poisoning was made according to medical history and carboxyhemoglobin >5% (>10% in smokers). |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- CO poisoned patients
Key inclusion criteria (1 listed)
- CO poisoned patients
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperbaric oxygen therapyPatients 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. | Procedure or surgery | Acute CO poisoning |
Primary outcome
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
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.
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
12 secondary outcomes
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 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 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 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 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 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
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
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
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 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 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 at 6 months after CO exposure in severe CO poisoned patients in the matched cohort
Time frame: At 6 months after CO exposure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2020.
- Derived from this study: PubMed 34074856Lee 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperbaric Oxygenation and Carbon Monoxide Poisoning, run by Wonju Severance Christian Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04656912, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2020.