Collect Blood Values With Induced Hypoxia, Induced Methemoglobinemia, and Induced Hypoxia and MethemoglobinemiaNCT03869840
Accuracy of Detection of Methemoglobin With Pulse Oximetry
An observational study of Collect Blood Values With Induced Hypoxia, Induced Methemoglobinemia, and Induced Hypoxia and Methemoglobinemia, run by Nonin Medical, Inc at 1 site in United States.
Trial summary
The non-invasive measurement of dysfunctional hemoglobins allows physicians to monitor levels in affected individuals without requiring blood samples or laboratory testing. Nonin Medical Inc, has recently developed a multi-wavelength device that measures carboxyhemoglobin and methemoglobin non-invasively. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Collect Blood Values With Induced Hypoxia, Induced Methemoglobinemia, and Induced Hypoxia and Methemoglobinemia
- What is being tested?
- Sensor to spot check blood levels
- Type of treatment
- Medical device
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Mar 2019to 29 Mar 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 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: A minimum of 12 subjects with a minimum of 200 data points for each primary and secondary objective will be enrolled in the study. The subject population will include both male and female subjects and will include a variety of skin tones.
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 31 (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).
Show all 18Show fewer
- Is currently pregnant (self-reported).
- 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 a hemoglobinopathy such as (anemia, bilirubinemia, sickle-cell anemia, inherited or congenital methemoglobinemia) (self-reported).
- The subject has a COHb greater than 3% or MetHb greater than 2% (based on the first blood sample analysis).
- Has taken blood thinners or medication with aspirin within the last 24 hours (self-reported).
- Has unacceptable collateral circulation from the ulnar artery (based on exam).
- Has donated more than 300 mL of blood within one month prior to start of study (self-reported).
- Is unwilling or unable to provide written informed consent to participate in the study.
- Is unwilling or unable to comply with the study procedures for the primary objectives.
- 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.
United States1 site
University of California San Francisco
San Francisco, California, 94118
About this study
The non-invasive measurement of dysfunctional hemoglobins allows physicians to monitor levels in affected individuals without requiring blood samples or laboratory testing. Nonin Medical Inc, has recently developed a multi-wavelength device that measures carboxyhemoglobin and methemoglobin non-invasively. The primary objective of this study is to validate %MetHb and SpO2 accuracy performance of the study device. Evaluations will be for the range of 0 to 15% MetHb with 95-100% SaO2 as assessed by CO-oximetry, and 0-15% MetHb accuracy under conditions of elevated HHb (SaO2 80-100%) as assessed by CO-oximetry, and SpO2 with 80-100% SaO2 during elevated MetHb as assessed by CO-oximetry.
Read the detailed description
The goal of this study is to collect data with induced hypoxia, with induced methemoglobinemia, and with induced hypoxia and methemoglobinemia. This will be accomplished in three runs with 24 to 28 plateaus total. The number of plateaus will be dependent on the subject's tolerance of the study procedure. The first run will be strictly induction of hypoxia down to approximately 70% saturation. The second run will be induction of hypoxia down to approximately 80% saturation with mild hypoxia at 7% MetHb. The third run will be induction of hypoxia down to approximately 80% saturation with a target MetHb of 11-15%.
- Being tested
- Sensor to spot check blood levels
- Medical subject headings
- Methemoglobinemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensor to spot check blood levelsDevice
Sensor to check blood levels, not used as intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Validate %MetHb
Validate %MetHb accuracy over the range of 0-15% MetHb with SaO2 greater than 95% as assessed by CO-oximetry
Measured: 4 days
Secondary outcomes (1)
Validate the %MetHb accuracy
Validate the %MetHb accuracy with SaO2 greater than 80% as assessed by CO-oximetry An accuracy value (Arms) for %SpO2 over the range of 80-100% SaO2 with elevated MetHb levels.
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2019
- Study start26 Mar 2019
- Primary completion29 Mar 2019
- Study completion29 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Collect Blood Values With Induced Hypoxia, Induced Methemoglobinemia, and Induced Hypoxia and MethemoglobinemiaStudies 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
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nonin Medical, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03869840
- Sponsor's protocol ID
- QATP3186
- Status last verified
- Mar 2019
- First submitted
- 8 Mar 2019
- Last updated
- 8 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Detection of Methemoglobin With Pulse Oximetry
- ClinicalTrials.gov ID
- NCT03869840
- Acronym / sponsor ID
- QATP3186
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Nonin Medical, IncIndustry (pharma, biotech, devices)
- Study start
- 26 Mar 2019 (actual)
- Primary completion
- 29 Mar 2019 (actual)
- Study completion
- 29 Mar 2019 (actual)
- First posted
- 11 Mar 2019 (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.
The non-invasive measurement of dysfunctional hemoglobins allows physicians to monitor levels in affected individuals without requiring blood samples or laboratory testing. Nonin Medical Inc, has recently developed a multi-wavelength device that measures carboxyhemoglobin and methemoglobin non-invasively. The primary objective of this study is to validate %MetHb and SpO2 accuracy performance of the study device. Evaluations will be for the range of 0 to 15% MetHb with 95-100% SaO2 as assessed by CO-oximetry, and 0-15% MetHb accuracy under conditions of elevated HHb (SaO2 80-100%) as assessed by CO-oximetry, and SpO2 with 80-100% SaO2 during elevated MetHb as assessed by CO-oximetry.
Detailed description
The goal of this study is to collect data with induced hypoxia, with induced methemoglobinemia, and with induced hypoxia and methemoglobinemia. This will be accomplished in three runs with 24 to 28 plateaus total. The number of plateaus will be dependent on the subject's tolerance of the study procedure. The first run will be strictly induction of hypoxia down to approximately 70% saturation. The second run will be induction of hypoxia down to approximately 80% saturation with mild hypoxia at 7% MetHb. The third run will be induction of hypoxia down to approximately 80% saturation with a target MetHb of 11-15%.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- A minimum of 12 subjects with a minimum of 200 data points for each primary and secondary objective will be enrolled in the study. The subject population will include both male and female subjects and will include a variety of skin tones.
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 (18 listed)
- Has a BMI greater than 31 (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 |
|---|---|---|
| Sensor to spot check blood levelsSensor to check blood levels, not used as intervention | Device | – |
Primary outcome
Validate %MetHb
Time frame: 4 days
Validate %MetHb accuracy over the range of 0-15% MetHb with SaO2 greater than 95% as assessed by CO-oximetry
1 secondary outcome
Validate the %MetHb accuracy
Time frame: 4 days
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 8 Apr 2019.
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 Collect Blood Values With Induced Hypoxia, Induced Methemoglobinemia, and Induced Hypoxia and Methemoglobinemia, 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 18 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 8 Apr 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 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?
Validate %MetHb (time frame: 4 days). 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 8 Apr 2019.