OximetryNCT04324385
Accuracy of Pulse Oximeters With Profound Hypoxia
An observational study of Oximetry, run by Compumedics Limited at 1 site in United States.
Trial summary
To test the accuracy of a non-invasive blood oxygen saturation monitor which is placed on a subject with profound hypoxia. Read more about this study
- Who is it for?
- Ages 21 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Oximetry
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Apr 2019to 10 Apr 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 21 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: All of the subjects enrolled in the study had normal hemoglobin levels (Hemoglobin ≤ 10gm•dl-1) and all were healthy non-smoking individuals of age 21-49.
Who may be able to join
- Normal hemoglobin levels (Hemoglobin ≤ 10gm•dl-1)
- Healthy
- Non-smoking individuals
- 21-49
Who cannot join
- Unhealthy
Trial locations and contacts
1 site in 1 country.
About this study
To test the accuracy of a non-invasive blood oxygen saturation monitor which is placed on a subject with profound hypoxia.
Read the detailed description
A radial arterial cannula was placed in either the left or right wrist of each subject for arterial blood sampling and blood pressure monitoring. Blood gas analysis to determine oxyhemoglobin saturation (SaO2)was performed using an ABL-90 multi-wavelength oximeter (Hemoximeter, Radiometer, Copenhagen, serial 1393-090R0359N0002). This instrument contains factory certified calibration standards and quality control algorithms.
Each subject had two control blood samples taken at the beginning of each experiment, while breathing room air. Hypoxia was then induced to different and stable levels of oxyhemoglobin saturation (between 70-100%) by having subjects breathe mixtures of nitrogen, room air, and carbon dioxide. Each plateau level of oxyhemoglobin saturation was maintained for at least 30 seconds or until reference pulse oximeters readings were stable. Two arterial blood samples were then obtained, approximately 30 seconds apart. Each stable plateau therefore was maintained for at least 60 seconds with SpO2 fluctuating by less than 2-3%. The plateaus were nominally at 100%, room air saturation, 93%, 90%, 87%, 85%, 82%, 80%, 77%, 75% and 70%. A total of 270 samples were obtained at the saturation plateaus across this span. Data were provided for analysis. At least 200 data points were collected for each type of oximeter and probe combination studied.
Pulse oximeter data is taken as 5 second averages corresponding to the point of arterial blood analysis. Individual data points may be missed or excluded for dropped signals or failure of the oximeter signal to achieve an appropriate plateau. Data is plotted as Hemoximeter data (SaO2) vs. pulse oximeter bias (SpO2 - SaO2). A different marker is used for each study subject. Linear regression is shown for all subjects combined, and the equation with R2 is shown on the plot. Mean bias is displayed as a solid horizontal line, and the upper and lower limits of agreement (mean bias ± 1.96•SD*) are shown by dashed horizontal lines. For the "pooled" plots, different markers are used for each pulse oximeter. Tables of mean, standard deviation, standard error, minimum, maximum, 95% confidence interval, count and root mean square are provided for each oximeter's bias, and all oximeters combined in the following ranges of SaO2 (Hemoximeter): 60 - 80%, 80 - 100%, 60 - 100%, 70 - 100%, 50 - 60%, 60 - 70%, 70 - 80%, 80 -90%, and 90 - 100%.
- Conditions
- Oximetry
What is being measured
The primary outcome is the main question the study is designed to answer.
Testing the accuracy of a new pulse oximeter device
The primary outcome measure was to find the agreement between methods of measurement with multiple observations per individual. Spo2 readings from the test device were compared with a factory certified and calibrated oxyhemoglobin saturation monitor (i.e. ABL-90 multi-wavelength oxiemter) and two other standard oximeter devices using root mean squared error as the measure of accuracy.
Measured: Approx. 60 mins per subject
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2020
- Study start9 Apr 2019
- Primary completion10 Apr 2019
- Study completion10 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OximetryStudies 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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Compumedics Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04324385
- Sponsor's protocol ID
- SOMFIT01
- Status last verified
- Mar 2020
- First submitted
- 23 Mar 2020
- Last updated
- 27 Mar 2020
- 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 27 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Pulse Oximeters With Profound Hypoxia
- ClinicalTrials.gov ID
- NCT04324385
- Acronym / sponsor ID
- SOMFIT01
- Conditions
- Oximetry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Compumedics LimitedIndustry (pharma, biotech, devices)
- Study start
- 9 Apr 2019 (actual)
- Primary completion
- 10 Apr 2019 (actual)
- Study completion
- 10 Apr 2019 (actual)
- First posted
- 27 Mar 2020 (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.
To test the accuracy of a non-invasive blood oxygen saturation monitor which is placed on a subject with profound hypoxia.
Detailed description
A radial arterial cannula was placed in either the left or right wrist of each subject for arterial blood sampling and blood pressure monitoring. Blood gas analysis to determine oxyhemoglobin saturation (SaO2)was performed using an ABL-90 multi-wavelength oximeter (Hemoximeter, Radiometer, Copenhagen, serial 1393-090R0359N0002). This instrument contains factory certified calibration standards and quality control algorithms.
Each subject had two control blood samples taken at the beginning of each experiment, while breathing room air. Hypoxia was then induced to different and stable levels of oxyhemoglobin saturation (between 70-100%) by having subjects breathe mixtures of nitrogen, room air, and carbon dioxide. Each plateau level of oxyhemoglobin saturation was maintained for at least 30 seconds or until reference pulse oximeters readings were stable. Two arterial blood samples were then obtained, approximately 30 seconds apart. Each stable plateau therefore was maintained for at least 60 seconds with SpO2 fluctuating by less than 2-3%. The plateaus were nominally at 100%, room air saturation, 93%, 90%, 87%, 85%, 82%, 80%, 77%, 75% and 70%. A total of 270 samples were obtained at the saturation plateaus across this span. Data were provided for analysis. At least 200 data points were collected for each type of oximeter and probe combination studied.
Pulse oximeter data is taken as 5 second averages corresponding to the point of arterial blood analysis. Individual data points may be missed or excluded for dropped signals or failure of the oximeter signal to achieve an appropriate plateau. Data is plotted as Hemoximeter data (SaO2) vs. pulse oximeter bias (SpO2 - SaO2). A different marker is used for each study subject. Linear regression is shown for all subjects combined, and the equation with R2 is shown on the plot. Mean bias is displayed as a solid horizontal line, and the upper and lower limits of agreement (mean bias ± 1.96•SD*) are shown by dashed horizontal lines. For the "pooled" plots, different markers are used for each pulse oximeter. Tables of mean, standard deviation, standard error, minimum, maximum, 95% confidence interval, count and root mean square are provided for each oximeter's bias, and all oximeters combined in the following ranges of SaO2 (Hemoximeter): 60 - 80%, 80 - 100%, 60 - 100%, 70 - 100%, 50 - 60%, 60 - 70%, 70 - 80%, 80 -90%, and 90 - 100%.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- All of the subjects enrolled in the study had normal hemoglobin levels (Hemoglobin ≤ 10gm•dl-1) and all were healthy non-smoking individuals of age 21-49.
Key inclusion criteria (4 listed)
- Normal hemoglobin levels (Hemoglobin ≤ 10gm•dl-1)
- Healthy
- Non-smoking individuals
- 21-49
Key exclusion criteria (1 listed)
- Unhealthy
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
Testing the accuracy of a new pulse oximeter device
Time frame: Approx. 60 mins per subject
The primary outcome measure was to find the agreement between methods of measurement with multiple observations per individual. Spo2 readings from the test device were compared with a factory certified and calibrated oxyhemoglobin saturation monitor (i.e. ABL-90 multi-wavelength oxiemter) and two other standard oximeter devices using root mean squared error as the measure of accuracy.
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 27 Mar 2020.
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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.
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 Oximetry, run by Compumedics Limited 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 4 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: finished, as of the sponsor's last update on 27 Mar 2020. 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?
Testing the accuracy of a new pulse oximeter device (time frame: Approx. 60 mins per subject). 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 27 Mar 2020.