Carbon Monoxide ExposureNCT01859156
End-Tidal Carbon Dioxide as a Measure of Carboxyhemoglobin in Carbon Monoxide Poisoning
An observational study of Carbon Monoxide Exposure, run by Hennepin Healthcare Research Institute at 1 site in United States.
Trial summary
The purpose of this study is to determine whether a relationship exists between EtCO2 and carboxyhemoglobin levels in carbon monoxide exposure. Our hypothesis is that a liner relationship exists between EtCO2 and carboxyhemoglobin in carbon monoxide poisoning. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carbon Monoxide Exposure
- How many people
- 151 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2006to Jul 2014
- 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: Patients presenting to the emergency department at an urban county hospital.
Who may be able to join
- Carbon monoxide exposure
Who cannot join
- Less than 18 years old
- Suicide attempt
- Unable to provide informed consent
- Pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
Hennepin County Medical Center
Minneapolis, Minnesota, 55415
About this study
Official title: End-Tidal Carbon Dioxide as a Measure of Carboxyhemoglobin in Carbon Monoxide
The purpose of this study is to determine whether a relationship exists between EtCO2 and carboxyhemoglobin levels in carbon monoxide exposure. Our hypothesis is that a liner relationship exists between EtCO2 and carboxyhemoglobin in carbon monoxide poisoning.
- Conditions
- Carbon Monoxide Exposure
- Keywords
- Carbon Monoxide, Carboxyhemoglobin, End-tidal carbon dioxide, Capnography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Carbon Monoxide Exposure | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
EtCO2
The EtCO2 level is measured by capnography and compared to the carboxyhemoglobin level.
Measured: Immediately upon study enrollment, an average time of 30 minutes post arrival to the hospital.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2013 (estimated)
- Study startOct 2006
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carbon Monoxide ExposureStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hennepin Healthcare Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James R Miner, MD, Principal investigator, Hennepin Healthcare Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01859156
- Sponsor's protocol ID
- 06-2713
- Status last verified
- Oct 2014
- First submitted
- 8 May 2013
- Last updated
- 29 Oct 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- End-Tidal Carbon Dioxide as a Measure of Carboxyhemoglobin in Carbon Monoxide
- ClinicalTrials.gov ID
- NCT01859156
- Acronym / sponsor ID
- 06-2713
- Conditions
- Carbon Monoxide Exposure
- Keywords
- Carbon Monoxide, Carboxyhemoglobin, End-tidal carbon dioxide, Capnography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Hennepin Healthcare Research InstituteUniversity, hospital or other
- Study start
- Oct 2006
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 21 May 2013 (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 determine whether a relationship exists between EtCO2 and carboxyhemoglobin levels in carbon monoxide exposure. Our hypothesis is that a liner relationship exists between EtCO2 and carboxyhemoglobin in carbon monoxide poisoning.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Carbon Monoxide Exposure | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting to the emergency department at an urban county hospital.
Key inclusion criteria (1 listed)
- Carbon monoxide exposure
Key exclusion criteria (4 listed)
- Less than 18 years old
- Suicide attempt
- Unable to provide informed consent
- Pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
EtCO2
Time frame: Immediately upon study enrollment, an average time of 30 minutes post arrival to the hospital.
The EtCO2 level is measured by capnography and compared to the carboxyhemoglobin level.
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 29 Oct 2014.
Related trials for Carbon Monoxide Exposure
Not yet recruitingObservational study
Prenatal Tobacco Exposure and Newborn Outcomes: A Maternal Urinary Cotinine Study
Tobacco Smoke Pollution, Maternal Exposure During Pregnancy
Not yet recruitingObservational study
Effects of CO Level on Pain, Sensory Function, and Subjective Health
Carbon Monoxide, Pain Perception, Sensory Thresholds, Anxiety, Depression, Tobacco Smoking
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 R Miner, MD principal investigator
Hennepin Healthcare Research Institute
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 Exposure, run by Hennepin Healthcare Research Institute 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 4 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 29 Oct 2014. 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 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?
EtCO2 (time frame: Immediately upon study enrollment, an average time of 30 minutes post arrival to the hospital.). 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 29 Oct 2014.