Carbon Monoxide PoisoningPhase 3NCT01100515
Hyperbaric Oxygen Therapy for Acute Domestic Carbon Monoxide (CO) Poisoning
A Phase 3 study testing normobaric oxygen therapy and Hyperbaric oxygen therapy in people with Carbon Monoxide Poisoning, run by University of Versailles at 1 site in France.
Trial summary
Carbon monoxide poisoning still places a burden on the healthcare system worldwide. While oxygen therapy is the cornerstone treatment, the role and practical modalities of hyperbaric oxygen therapy (HBO) remain controversial. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Carbon Monoxide Poisoning
- What is being tested?
- normobaric oxygen therapy and Hyperbaric oxygen therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 179 participants
- Where
- 1 siteFrance
- Study dates
- Oct 1989to Feb 2000
- Phase
- Phase 3
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients older than 15 years of age
- admitted for domestic CO poisoning within 12 hours after the end of CO exposure.
- had transient loss of consciousness (syncope, malaise)
- carboxyhemoglobin level at presentation >10% or 5%, in smokers and non-smokers, respectively.
Who cannot join
- poisoning by more than one compound (e.g., CO plus a drug or CO plus other toxic gases such as those found in fire smoke
- suicide attempt
- pregnancy
- coma
- contraindications to HBO (circulatory collapse or pneumothorax)
- technical obstacles to HBO
Show all 9Show fewer
- non domestic CO poisoning
- difficulty in determining whether the patient experienced initial loss of consciousness or initial coma
- consent refusal.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 3 Study of Hyperbaric Oxygen Therapy in Non-Comatose Patients With Acute Domestic Carbon Monoxide Poisoning
Carbon monoxide poisoning still places a burden on the healthcare system worldwide. While oxygen therapy is the cornerstone treatment, the role and practical modalities of hyperbaric oxygen therapy (HBO) remain controversial. This study aimed at comparing one session of HBO at 2 absolute atmosphere followed by 4 hours of normobaric oxygen therapy to 6 hours of normobaric oxygen therapy in adult victims of acute domestic carbon monoxide poisoning and without coma.
- Conditions
- Carbon Monoxide Poisoning
- Being tested
- normobaric oxygen therapy, Hyperbaric oxygen therapy
- Keywords
- intoxication, carbon monoxide, adults, domestic accident, acute domestic carbon monoxide poisoning
- 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.
normobaric oxygen therapyOther
oxygen therapy was delivered via a full face mask at high flow to achieve 100% of inspired oxygen fraction
Hyperbaric oxygen therapyOther
Hyperbaric oxygen therapy was delivered in a hyperbaric chamber, pressurized at 2 absolute atmosphere (1 hour plateau) and the patient breathed high oxygen concentration via a full face mask followed by 4 hours of normobaric oxygen therapy
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm | Experimental | Hyperbaric oxygen therapy at 2 absolute atmosphere (1-hour plateau) followed by 4 hours of normobaric oxygen therapy Receives: Other: Hyperbaric oxygen therapy |
| Control | Active comparator | 6 hours course of normobaric oxygen therapy via a face full mask Receives: Other: normobaric oxygen therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
full recovery
Full recovery was defined as an absence of symptoms reported on the self-assessment questionnaire with a normal physical exam (including normal neuropsychological functions).
Measured: at one month
Secondary outcomes (4)
persistent neurological sequels
Neurological sequels were considered persistent (PNS) if they were present both at hospital discharge and at one-month evaluation, regardless of the type of manifestation
Measured: at one month
delayed neurological sequels
Delayed neurological sequelae (DNS) were any neurological manifestations that appeared between hospital discharge and one-month evaluation, regardless of their severity. Patients with DNS were those considered fully recovered at hospital discharge but with neurological manifestations at one-month evaluation
Measured: at one month
variations in carboxyhemoglobin levels
the difference in serum carboxyhemoglobin levels between baseline values and values recorded immeadiately after study treatment completion
Measured: at 12 hours from randomization
serious adverse events
any complications of hyperbaric oxygen therapy
Measured: at one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2010 (estimated)
- Study startOct 1989
- Primary completionJan 2000
- Study completionFeb 2000
Why it stopped: this study was suspended for futility
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carbon Monoxide PoisoningStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 179 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Versailles
- Sponsor type
- University, hospital or other
- Collaborators
- Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01100515
- Sponsor's protocol ID
- CO89
- Status last verified
- Apr 2010
- First submitted
- 5 Apr 2010
- Last updated
- 9 Apr 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 Study of Hyperbaric Oxygen Therapy in Non-Comatose Patients With Acute Domestic Carbon Monoxide Poisoning
- ClinicalTrials.gov ID
- NCT01100515
- Acronym / sponsor ID
- CO89
- Conditions
- Carbon Monoxide Poisoning
- Keywords
- intoxication, carbon monoxide, adults, domestic accident, acute domestic carbon monoxide poisoning
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: this study was suspended for futility
- Enrolment
- 179 participants (actual)
- Lead sponsor
- University of VersaillesUniversity, hospital or other
- Collaborators
- Assistance Publique - Hôpitaux de Paris
- Study start
- Oct 1989
- Primary completion
- Jan 2000 (actual)
- Study completion
- Feb 2000 (actual)
- First posted
- 9 Apr 2010 (estimated)
- 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.
Carbon monoxide poisoning still places a burden on the healthcare system worldwide. While oxygen therapy is the cornerstone treatment, the role and practical modalities of hyperbaric oxygen therapy (HBO) remain controversial. This study aimed at comparing one session of HBO at 2 absolute atmosphere followed by 4 hours of normobaric oxygen therapy to 6 hours of normobaric oxygen therapy in adult victims of acute domestic carbon monoxide poisoning and without coma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental arm | Experimental | Other: Hyperbaric oxygen therapyHyperbaric oxygen therapy at 2 absolute atmosphere (1-hour plateau) followed by 4 hours of normobaric oxygen therapy |
| Control | Active comparator | Other: normobaric oxygen therapy6 hours course of normobaric oxygen therapy via a face full mask |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- patients older than 15 years of age
- admitted for domestic CO poisoning within 12 hours after the end of CO exposure.
- had transient loss of consciousness (syncope, malaise)
- carboxyhemoglobin level at presentation >10% or 5%, in smokers and non-smokers, respectively.
Key exclusion criteria (9 listed)
- poisoning by more than one compound (e.g., CO plus a drug or CO plus other toxic gases such as those found in fire smoke
- suicide attempt
- pregnancy
- coma
- contraindications to HBO (circulatory collapse or pneumothorax)
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 |
|---|---|---|
| normobaric oxygen therapyoxygen therapy was delivered via a full face mask at high flow to achieve 100% of inspired oxygen fraction | Other | Control |
| Hyperbaric oxygen therapyHyperbaric oxygen therapy was delivered in a hyperbaric chamber, pressurized at 2 absolute atmosphere (1 hour plateau) and the patient breathed high oxygen concentration via a full face mask followed by 4 hours of normobaric oxygen therapy | Other | Experimental arm |
Primary outcome
full recovery
Time frame: at one month
Full recovery was defined as an absence of symptoms reported on the self-assessment questionnaire with a normal physical exam (including normal neuropsychological functions).
4 secondary outcomes
persistent neurological sequels
Time frame: at one month
delayed neurological sequels
Time frame: at one month
variations in carboxyhemoglobin levels
Time frame: at 12 hours from randomization
serious adverse events
Time frame: at one month
Results and safety
The study was stopped early (reason given: this study was suspended for futility). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2010.
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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?
A Phase 3 study testing normobaric oxygen therapy and Hyperbaric oxygen therapy in people with Carbon Monoxide Poisoning, run by University of Versailles at 1 site in France.
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 4 inclusion and 9 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: stopped early, as of the sponsor's last update on 9 Apr 2010. 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 France. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: this study was suspended for futility). Results are not available in the source record.
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?
full recovery (time frame: at one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Apr 2010.