Carbon Monoxide PoisoningNCT03004235
Suspected Cases of Carbon Monoxide Poisoning in the ED
An observational study of Carbon Monoxide Poisoning, run by Nonin Medical, Inc at 1 site in United States.
Trial summary
The purpose of this study is to collect non-invasive observational data in suspected or known carbon monoxide poisoning. 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?
- Observational data collection
- Type of treatment
- Medical device
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2016to 8 Aug 2019
- 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 participants will be selected based on symptoms in the Emergency Department.
Who may be able to join
- Known or suspected carbon monoxide poisoning
Who cannot join
- Less than 18 years of age
Trial locations and contacts
1 site in 1 country.
United States1 site
Hennepin County Medical Center
Minneapolis, Minnesota, 55404
About this study
Official title: ED Data Collection of Suspected Carbon Monoxide Poisoning
The purpose of this study is to collect non-invasive observational data in suspected or known carbon monoxide poisoning.
- Conditions
- Carbon Monoxide Poisoning
- Being tested
- Observational data collection
- 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.
Observational data collectionDevice
Observational data collection
What is being measured
The primary outcome is the main question the study is designed to answer.
Values from the test device will be compared to the values from co-oximetry to determine the accuracy of the test device
Measured: Through study completion, an average of 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2016 (estimated)
- Study startDec 2016
- Primary completion8 Aug 2019
- Study completion8 Aug 2019
Why it stopped: IRB is reviewing all studies at the institution and are on hold
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nonin Medical, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- James Miner, MD, Principal investigator, Hennepin County Medical Center, Minneapolis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03004235
- Sponsor's protocol ID
- QATP2978
- Status last verified
- Jul 2018
- First submitted
- 21 Dec 2016
- Last updated
- 12 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ED Data Collection of Suspected Carbon Monoxide Poisoning
- ClinicalTrials.gov ID
- NCT03004235
- Acronym / sponsor ID
- QATP2978
- Conditions
- Carbon Monoxide Poisoning
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: IRB is reviewing all studies at the institution and are on hold
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Nonin Medical, IncIndustry (pharma, biotech, devices)
- Study start
- Dec 2016
- Primary completion
- 8 Aug 2019 (actual)
- Study completion
- 8 Aug 2019 (actual)
- First posted
- 28 Dec 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.
The purpose of this study is to collect non-invasive observational data in suspected or known carbon monoxide poisoning.
Study design
- Observational model
- Cohort
- 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 participants will be selected based on symptoms in the Emergency Department.
Key inclusion criteria (1 listed)
- Known or suspected carbon monoxide poisoning
Key exclusion criteria (1 listed)
- Less than 18 years of age
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 |
|---|---|---|
| Observational data collectionObservational data collection | Device | – |
Primary outcome
Values from the test device will be compared to the values from co-oximetry to determine the accuracy of the test device
Time frame: Through study completion, an average of 2 years.
Results and safety
The study was stopped early (reason given: IRB is reviewing all studies at the institution and are on hold). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2019.
- Individual participant dataSharing planned: No
Related trials for Carbon Monoxide Poisoning
Not yet recruitingPhase 1/2
Carbon Monoxide Hyperbaric Oxygen With Steroid Therapy
Carbon Monoxide Poisoning, Carbon Monoxide Intoxication
Not yet recruitingObservational study
Prenatal Tobacco Exposure and Newborn Outcomes: A Maternal Urinary Cotinine Study
Tobacco Smoke Pollution, Maternal Exposure During Pregnancy
RecruitingPhase 4
The Efficacy of Dexamethasone in Combination With N-acetylcysteine in Preventing Neurocognitive Sequelae Due to Carbon Monoxide Poisoning
Carbon Monoxide Poisoning, Delayed Neurocognitive Sequelae
RecruitingObservational study
Microparticles Blood Level in Acute Carbon Monoxide Poisoning
Carbon Monoxide Poisoning
RecruitingObservational study
CARbon monoxidE intoxiCatiOn in Korea: Prospective Cohort (CARE CO Cohort)
Carbon Monoxide Poisoning, Myocardial Injury
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.
James Miner, MD principal investigator
Hennepin County Medical Center, Minneapolis
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 Nonin Medical, Inc at 1 site in United States.
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 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: stopped early, as of the sponsor's last update on 12 Aug 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 United States. 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 stopped early (reason given: IRB is reviewing all studies at the institution and are on hold). 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?
Values from the test device will be compared to the values from co-oximetry to determine the accuracy of the test device (time frame: Through study completion, an average of 2 years.). 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 12 Aug 2019; AzTrials last refreshed its copy on 7 Nov 2026.