Carbon Monoxide PoisoningCOVAPNCT03669848
Is Transcutaneous Carbon Monoxide Saturation of E-cigarette Users Comparable to That of Smokers?
An observational study of Carbon Monoxide Poisoning, run by University Hospital, Tours at 1 site in France.
Trial summary
Suspicions of carbon monoxide poisoning that lead to the treatment of victims are numerous. Measurement of transcutaneous carbon monoxide saturation (SpCO) is a useful diagnostic and triage tool for victims and the toxic threshold is clearly defined for both non-smokers (SpCO> 5%) and smokers ( SpCO> 10%). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Carbon Monoxide Poisoning
- What is being tested?
- Pulse CO-oximetry
- How many people
- 1,116 participants
- Where
- 1 siteFrance
- Study dates
- 12 Sep 2018to 23 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Active smoker presenting to adult emergency department
Who may be able to join
- Patient presenting to adult emergency department
- Age ≥ 18 years
Who cannot join
- Passive exposure to tobacco
- Mixed exposure (tobacco / e-cigarette)
- Patient having objected to the processing of his data
Trial locations and contacts
1 site in 1 country.
France1 site
Adult Emergency Department, University Hospital, Tours
Tours, 37044
About this study
Suspicions of carbon monoxide poisoning that lead to the treatment of victims are numerous. Measurement of transcutaneous carbon monoxide saturation (SpCO) is a useful diagnostic and triage tool for victims and the toxic threshold is clearly defined for both non-smokers (SpCO> 5%) and smokers ( SpCO> 10%).
Currently, the use of e-cigarettes is democratizing. Unfortunately, the threshold for toxic SpCO is not defined for this patient profile.
The risk is treating in excess or worse than underestimating carbon monoxide poisoning in e-cigarette users who would be exposed to carbon monoxide exposure.
- Conditions
- Carbon Monoxide Poisoning
- Being tested
- Pulse CO-oximetry
- Keywords
- carbon monoxide poisoning, e-cigarette user, transcutaneous saturation measurements
- 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.
Pulse CO-oximetryOther
Measuring blood Carbon Monoxide levels with Pulse CO-oximetry (SpCO)
| Study group | Role | What they receive |
|---|---|---|
| Pulse CO-oximetry | Measuring blood Carbon Monoxide levels with Pulse CO-oximetry (SpCO) Measurements are taken with a noninvasive method by placing a sensor on a patient, usually on the fingertip. Receives: Other: Pulse CO-oximetry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Carbon Monoxide levels measurements
Measuring blood Carbon Monoxide levels with Pulse CO-oximetry (SpCO)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2018
- Study start12 Sep 2018
- Primary completion23 Sep 2018
- Study completion23 Sep 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 University Hospital, ToursThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 1,116 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Leila CAMBONI, MD, Principal investigator, University Hospital, Tours
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03669848
- Sponsor's protocol ID
- RIPH3-RNI18 / COVAP
- Other IDs
- 2018-A01471-54
- Acronym
- COVAP
- Status last verified
- Nov 2019
- First submitted
- 12 Sep 2018
- Last updated
- 13 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Transcutaneous Carbon Monoxide Saturation of E-cigarette Users Comparable to That of Smokers?
- ClinicalTrials.gov ID
- NCT03669848
- Acronym / sponsor ID
- COVAP / RIPH3-RNI18 / COVAP
- Conditions
- Carbon Monoxide Poisoning
- Keywords
- carbon monoxide poisoning, e-cigarette user, transcutaneous saturation measurements
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,116 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- 12 Sep 2018 (actual)
- Primary completion
- 23 Sep 2018 (actual)
- Study completion
- 23 Sep 2018 (actual)
- First posted
- 13 Sep 2018 (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.
Suspicions of carbon monoxide poisoning that lead to the treatment of victims are numerous. Measurement of transcutaneous carbon monoxide saturation (SpCO) is a useful diagnostic and triage tool for victims and the toxic threshold is clearly defined for both non-smokers (SpCO> 5%) and smokers ( SpCO> 10%).
Currently, the use of e-cigarettes is democratizing. Unfortunately, the threshold for toxic SpCO is not defined for this patient profile.
The risk is treating in excess or worse than underestimating carbon monoxide poisoning in e-cigarette users who would be exposed to carbon monoxide exposure.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pulse CO-oximetry | – | Other: Pulse CO-oximetryMeasuring blood Carbon Monoxide levels with Pulse CO-oximetry (SpCO) Measurements are taken with a noninvasive method by placing a sensor on a patient, usually on the fingertip. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Active smoker presenting to adult emergency department
Key inclusion criteria (2 listed)
- Patient presenting to adult emergency department
- Age ≥ 18 years
Key exclusion criteria (3 listed)
- Passive exposure to tobacco
- Mixed exposure (tobacco / e-cigarette)
- Patient having objected to the processing of his data
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 |
|---|---|---|
| Pulse CO-oximetryMeasuring blood Carbon Monoxide levels with Pulse CO-oximetry (SpCO) | Other | Pulse CO-oximetry |
Primary outcome
Blood Carbon Monoxide levels measurements
Time frame: Baseline
Measuring blood Carbon Monoxide levels with Pulse CO-oximetry (SpCO)
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 13 Nov 2019.
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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.
Leila CAMBONI, MD principal investigator
University Hospital, Tours
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 University Hospital, Tours 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 2 inclusion and 3 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 13 Nov 2019. 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 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?
Blood Carbon Monoxide levels measurements (time frame: Baseline). 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 Nov 2019.