Carbon Monoxide PoisoningMAS-CONCT02931448
Occult Carbon Monoxide Poisoning Detection by Pulsated Carboxymetry in an Emergency Department
An observational study of Carbon Monoxide Poisoning, run by Poitiers University Hospital at 1 site in France.
Trial summary
In France, the carbon monoxide is one of the first causes of the accidental poisonings with approximately 8000 cases a year, among which 500 deaths. The severe forms are translated by neurological disorders even a coma or the death straight away. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carbon Monoxide Poisoning
- What is being tested?
- Dosage of the blood HbCO thanks to the carboxymeter MASIMO RAD 57
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- Start not givento Sep 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The eligible patients are the ones appearing at emergencies for headaches, nausea and/or vomitings, faintness with or without loss of consciousness, dizzinesses, asthenia, and presenting all the criteria of inclusion and the absence of the criteria of not inclusion. Considering the particularity of the foetal poisoning in the carbon monoxide, the pregnant women cannot be included in the study.
Who may be able to join
- Patients over 18 years old consult in ED for :
- cephalalgia
- syncope
- weakness
- nausea
- vomiting
- asthenia
Who cannot join
- temperature over 38.5 °C
Trial locations and contacts
1 site in 1 country.
About this study
In France, the carbon monoxide is one of the first causes of the accidental poisonings with approximately 8000 cases a year, among which 500 deaths.
The severe forms are translated by neurological disorders even a coma or the death straight away. The more insidious forms with a little carboxyhémoglobine level give rise to frustrate clinical pictures, mimicking flu or intestinal syndromes. The syndrome post--intervallaire corresponds to the appearance of remote neuropsychiatric disorders of the poisoning. Its appearance and its gravity are not correlated in the gravity of the initial poisoning, however the precocity of the treatment tends to decrease its frequency.
Read more
Carbon monoxide elimination is made under unchanged form in the expired air. In a spontaneous way, the half-life in ambient air is of the order of 4 hours. In ventilation in isobaric pure oxygen, the half-life is shortened at 80 minutes and in hyperbaric oxygen at 23 minutes.
This imposes a fast diagnosis for two reasons:
- For poisonings with low level, the more the investigators wait to measure the carboxyhémoglobine (HBCO), the more they risk not to detect it.
- The oxygen therapy decreases the duration of the poisoning and thus the tissular suffering.
Actually the risk is important to pass next to the diagnosis and to let leave a patient without adapted care and without technical intervention to eliminate the source of the poisoning.
Presently, to make the diagnosis, the investigators possess the analysis of the blood HbCO by realization of gas of the venous blood, which are taken in emergencies, but very often a few hours after the end of the exposure at the source of poisoning, what is translated by a disappearance of the symptoms and an underestimate of the initial blood HbCO. Since 2005, MASIMO laboratory commercialize a pulse carboxymètre, the RAD 57, which allows to estimate the carboxyhémoglobinémie in a not invasive way.
Lot of studies showed the interest of its use in the early screening of carbon monoxide poisonings, allowing a faster dosage of the blood HbCO, and thus an also faster adapted care.
- Conditions
- Carbon Monoxide Poisoning
- Being tested
- Dosage of the blood HbCO thanks to the carboxymeter MASIMO RAD 57
- Keywords
- Device assessment
- 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.
Dosage of the blood HbCO thanks to the carboxymeter MASIMO RAD 57Device
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of poisoning carbon monoxide confirmed
Measured: up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2016 (estimated)
- Primary completionSep 2018
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.
- More trials run by Poitiers University HospitalThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02931448
- Sponsor's protocol ID
- MAS-CO
- Acronym
- MAS-CO
- Status last verified
- Apr 2020
- First submitted
- 19 Feb 2016
- Last updated
- 13 Apr 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Occult Carbon Monoxide Poisoning Detection by Pulsated Carboxymetry in an Emergency Department
- ClinicalTrials.gov ID
- NCT02931448
- Acronym / sponsor ID
- MAS-CO / MAS-CO
- Conditions
- Carbon Monoxide Poisoning
- Keywords
- Device assessment
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Primary completion
- Sep 2018 (actual)
- First posted
- 13 Oct 2016 (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.
In France, the carbon monoxide is one of the first causes of the accidental poisonings with approximately 8000 cases a year, among which 500 deaths.
The severe forms are translated by neurological disorders even a coma or the death straight away. The more insidious forms with a little carboxyhémoglobine level give rise to frustrate clinical pictures, mimicking flu or intestinal syndromes. The syndrome post--intervallaire corresponds to the appearance of remote neuropsychiatric disorders of the poisoning. Its appearance and its gravity are not correlated in the gravity of the initial poisoning, however the precocity of the treatment tends to decrease its frequency.
Carbon monoxide elimination is made under unchanged form in the expired air. In a spontaneous way, the half-life in ambient air is of the order of 4 hours. In ventilation in isobaric pure oxygen, the half-life is shortened at 80 minutes and in hyperbaric oxygen at 23 minutes.
This imposes a fast diagnosis for two reasons:
- For poisonings with low level, the more the investigators wait to measure the carboxyhémoglobine (HBCO), the more they risk not to detect it.
- The oxygen therapy decreases the duration of the poisoning and thus the tissular suffering.
Actually the risk is important to pass next to the diagnosis and to let leave a patient without adapted care and without technical intervention to eliminate the source of the poisoning.
Presently, to make the diagnosis, the investigators possess the analysis of the blood HbCO by realization of gas of the venous blood, which are taken in emergencies, but very often a few hours after the end of the exposure at the source of poisoning, what is translated by a disappearance of the symptoms and an underestimate of the initial blood HbCO. Since 2005, MASIMO laboratory commercialize a pulse carboxymètre, the RAD 57, which allows to estimate the carboxyhémoglobinémie in a not invasive way.
Lot of studies showed the interest of its use in the early screening of carbon monoxide poisonings, allowing a faster dosage of the blood HbCO, and thus an also faster adapted care.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The eligible patients are the ones appearing at emergencies for headaches, nausea and/or vomitings, faintness with or without loss of consciousness, dizzinesses, asthenia, and presenting all the criteria of inclusion and the absence of the criteria of not inclusion. Considering the particularity of the foetal poisoning in the carbon monoxide, the pregnant women cannot be included in the study.
Key inclusion criteria (7 listed)
- cephalalgia
- syncope
- weakness
- nausea
- vomiting
Key exclusion criteria (1 listed)
- temperature over 38.5 °C
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 |
|---|---|---|
| Dosage of the blood HbCO thanks to the carboxymeter MASIMO RAD 57 | Device | – |
Primary outcome
Incidence of poisoning carbon monoxide confirmed
Time frame: up to 24 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2020.
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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 Carbon Monoxide Poisoning, run by Poitiers University Hospital 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 7 inclusion and 1 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: withdrawn, as of the sponsor's last update on 13 Apr 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 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Incidence of poisoning carbon monoxide confirmed (time frame: up to 24 hours). 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 13 Apr 2020.