Carbon Monoxide PoisoningNCT03030833
Dysfunctional Hemoglobin Pulse Oximetry
An observational study of Carbon Monoxide Poisoning, run by Nonin Medical, Inc at 1 site in United States.
Trial summary
The purpose of the study is to assess device performance in the presence of carbon monoxide. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Carbon Monoxide Poisoning
- What is being tested?
- Pulse Oximeter
- Type of treatment
- Medical device
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Feb 2017to 30 Apr 2017
- 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 to 50 years
- All sexes
- Adult
Study population: Healthy male and females.
Who may be able to join
- The subject is male or female.
- The subject is of any racial or ethnic group.
- The subject is between 18 years and 50 years of age (self-reported).
- The subject does not have significant medical problems (self-reported).
- The subject is willing to provide written informed consent and is willing and able to comply with study procedures.
Who cannot join
- Has a BMI greater than 30.0 (calculated from self-reported weight and height).
- Has had any relevant injury at the sensor location site (self-reported).
- Has a deformity or abnormalities that may prevent proper application of the device under test (based on visual inspection).
- Has a known respiratory condition (self-reported).
- Is currently a smoker (self-reported).
- Has a known heart or cardiovascular condition (self-reported).
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- Is currently pregnant (positive serum pregnancy test at screening visit or positive urine POC test on day of study).
- Is female and actively trying to get pregnant (self-reported).
- Has a clotting disorder (self-reported).
- Has Raynaud's Disease (self-reported).
- Is known to have anemia (hemoglobin value below lower range of normal for gender)
- Is known to have a hemoglobinopathy such as sickle-cell anemia or thalassemia (abnormal hemoglobin electrophoresis).
- Is known to have a inherited or congenital methemoglobinemia (self-reported).
- Has unacceptable collateral circulation from the ulnar artery (based on exam).
- Is unwilling or unable to provide written informed consent to participate in the study.
- Has another health condition which in the opinion of the principal investigator makes him/her unsuitable for testing.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dysfunctional Hemoglobin Pulse Oximeter
The purpose of the study is to assess device performance in the presence of carbon monoxide.
- Conditions
- Carbon Monoxide Poisoning
- Being tested
- Pulse Oximeter
- 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 OximeterDevice
Comparison of pulse oximetry to blood gas analyzer.
What is being measured
The primary outcome is the main question the study is designed to answer.
Carboxyhemoglobin accuracy
Values from the test device will be compared to the values from co-oximetry to determine accuracy of the test device.
Measured: Through study completion, an average of 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2017 (estimated)
- Study start6 Feb 2017
- Primary completion30 Apr 2017
- Study completion30 Apr 2017
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
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nonin Medical, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David B MacLeod, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03030833
- Sponsor's protocol ID
- QATP3040
- Status last verified
- Jan 2017
- First submitted
- 23 Jan 2017
- Last updated
- 1 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dysfunctional Hemoglobin Pulse Oximeter
- ClinicalTrials.gov ID
- NCT03030833
- Acronym / sponsor ID
- QATP3040
- Conditions
- Carbon Monoxide Poisoning
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Nonin Medical, IncIndustry (pharma, biotech, devices)
- Study start
- 6 Feb 2017 (actual)
- Primary completion
- 30 Apr 2017 (actual)
- Study completion
- 30 Apr 2017 (actual)
- First posted
- 25 Jan 2017 (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 the study is to assess device performance in the presence of carbon monoxide.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Age groups
- Adult
- Study population
- Healthy male and females.
Key inclusion criteria (5 listed)
- The subject is male or female.
- The subject is of any racial or ethnic group.
- The subject is between 18 years and 50 years of age (self-reported).
- The subject does not have significant medical problems (self-reported).
- The subject is willing to provide written informed consent and is willing and able to comply with study procedures.
Key exclusion criteria (16 listed)
- Has a BMI greater than 30.0 (calculated from self-reported weight and height).
- Has had any relevant injury at the sensor location site (self-reported).
- Has a deformity or abnormalities that may prevent proper application of the device under test (based on visual inspection).
- Has a known respiratory condition (self-reported).
- Is currently a smoker (self-reported).
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 OximeterComparison of pulse oximetry to blood gas analyzer. | Device | – |
Primary outcome
Carboxyhemoglobin accuracy
Time frame: Through study completion, an average of 3 months.
Values from the test device will be compared to the values from co-oximetry to determine accuracy of the test device.
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 1 Sep 2017.
- Individual participant dataSharing planned: No
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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.
David B MacLeod, MD principal investigator
Duke University
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 5 inclusion and 16 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 1 Sep 2017. 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?
Carboxyhemoglobin accuracy (time frame: Through study completion, an average of 3 months.). 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 1 Sep 2017.