Carbon Monoxide PoisoningPhase 3NCT01099995
Hyperbaric Oxygen Therapy for Comatose Patients With Acute Carbon Monoxide Poisoning
A Phase 3 study testing 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?
- Hyperbaric oxygen therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 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
- initial coma, regardless of consciousness at hospital admission
- carboxyhemoglobin level at presentation greater than 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
- contraindications to HBO (circulatory collapse or pneumothorax)
- technical obstacles to HBO
- 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 for 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 two sessions of HBO at 2 absolute atmosphere and one session of HBO at 2 absolute atmosphere followed by 4 hours of normobaric oxygen therapy in comatose adult victims of acute domestic carbon monoxide poisoning.
- Conditions
- Carbon Monoxide Poisoning
- Being tested
- Hyperbaric oxygen therapy
- Keywords
- domestic accident, coma, carbon monoxide, intoxication, acute domestic carbon monoxide poisoning
- Medical subject headings
- Carbon Monoxide Poisoning, Coma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperbaric oxygen therapyOther
one dive at 2 absolute atmosphere (1-hour plateau) with 30 min time for compression and decompression - oxygen was delivered via a full face mask at high concentration to achieve a 100% inspired fraction of oxygen or via mechanical ventilation
hyperbaric oxygen therapyOther
two dives at 2 absolute atmosphere (1-hour plateau) with 30 min of compression and 30 min of decompression - oxygen being delivered via a full face mask at 100% inspired oxygen fraction or via mechanical ventilation
| Study group | Role | What they receive |
|---|---|---|
| One HBO session | Active comparator | hyperbaric oxygen therapy one dive at 2 absolute atmosphere (1-hour plateau) - oxygen was delivered via a full face mask - followed by 4 hours of normobaric oxygen therapy Receives: Other: Hyperbaric oxygen therapy |
| 2 HBO sessions | Experimental | Two sessions of hyperbaric oxygen therapy at 2 absolute atmosphere (1-hour plateau) with oxygen delivered via a full face mask at 100% inspired oxygen fraction or via mechanical ventilation Receives: Other: hyperbaric oxygen therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
complete recovery
Complete 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
the difference in carboxyhemoglobin levels before/after treatment completion
the difference between serum levels of carboxyhemoglobin at baseline and those recorded immedaitely after study treatment completion
Measured: at 12 hours from randomization
serious adverse events
any complication 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 posted8 Apr 2010 (estimated)
- Study startOct 1989
- Primary completionJan 2000
- Study completionFeb 2000
Why it stopped: the study was halted after the first interim analysis as there were significantly more patients who recovered at one month in the control arm
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
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Versailles
- Sponsor type
- University, hospital or other
- Collaborators
- Assistance Publique - Hôpitaux de Paris
- Investigators
- Djillali Annane, MD, Study chair, Assistance Publique - Hôpitaux de ParisJean Claude Raphael, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01099995
- Sponsor's protocol ID
- CO89-2
- Status last verified
- Apr 2010
- First submitted
- 5 Apr 2010
- Last updated
- 8 Apr 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 Study of Hyperbaric Oxygen Therapy for Comatose Patients With Acute Domestic Carbon Monoxide Poisoning
- ClinicalTrials.gov ID
- NCT01099995
- Acronym / sponsor ID
- CO89-2
- Conditions
- Carbon Monoxide Poisoning
- Keywords
- domestic accident, coma, carbon monoxide, intoxication, acute domestic carbon monoxide poisoning
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: the study was halted after the first interim analysis as there were significantly more patients who recovered at one month in the control arm
- Enrolment
- 170 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
- 8 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 two sessions of HBO at 2 absolute atmosphere and one session of HBO at 2 absolute atmosphere followed by 4 hours of normobaric oxygen therapy in comatose adult victims of acute domestic carbon monoxide poisoning.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| One HBO session | Active comparator | Other: Hyperbaric oxygen therapyhyperbaric oxygen therapy one dive at 2 absolute atmosphere (1-hour plateau) - oxygen was delivered via a full face mask - followed by 4 hours of normobaric oxygen therapy |
| 2 HBO sessions | Experimental | Other: hyperbaric oxygen therapyTwo sessions of hyperbaric oxygen therapy at 2 absolute atmosphere (1-hour plateau) with oxygen delivered via a full face mask at 100% inspired oxygen fraction or via mechanical ventilation |
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
- initial coma, regardless of consciousness at hospital admission
- carboxyhemoglobin level at presentation greater than 10% or 5%, in smokers and non-smokers, respectively
Key exclusion criteria (8 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
- contraindications to HBO (circulatory collapse or pneumothorax)
- technical obstacles to HBO
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 therapyone dive at 2 absolute atmosphere (1-hour plateau) with 30 min time for compression and decompression - oxygen was delivered via a full face mask at high concentration to achieve a 100% inspired fraction of oxygen or via mechanical ventilation | Other | One HBO session |
| hyperbaric oxygen therapytwo dives at 2 absolute atmosphere (1-hour plateau) with 30 min of compression and 30 min of decompression - oxygen being delivered via a full face mask at 100% inspired oxygen fraction or via mechanical ventilation | Other | 2 HBO sessions |
Primary outcome
complete recovery
Time frame: at one month
Complete 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
the difference in carboxyhemoglobin levels before/after treatment completion
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: the study was halted after the first interim analysis as there were significantly more patients who recovered at one month in the control arm). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 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.
Djillali Annane, MD study chair
Assistance Publique - Hôpitaux de Paris
Jean Claude Raphael principal investigator
Assistance Publique - Hôpitaux de Paris
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 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 8 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 8 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: the study was halted after the first interim analysis as there were significantly more patients who recovered at one month in the control arm). 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?
complete 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 8 Apr 2010.