Pulse OximetryNCT01613222
SpO2 System Accuracy Testing With Different Sensors
A study testing Pulse oximetry in people with Pulse Oximetry, run by GE Healthcare at 1 site in United States.
Trial summary
A study to test the accuracy of SpO2 sensors with various patient monitors, co-oximeters, and modules. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulse Oximetry
- What is being tested?
- Pulse oximetry
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jun 2012to 15 Feb 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Ability to provide written informed consent or have a legally authorized representative provide written informed consent
- Subjects who are 18-55 years of age
- Subjects must be willing and able to comply with study procedures
- HbCO<3% (for smokers only)
Who cannot join
- Subject or a legally authorized representative is unable to provide written inform consent.
- Subjects that are considered morbidly obese (defined as BMI > 39.5),
- Subjects with injuries, deformities or abnormalities that may prevent proper application of the device under test,
- Smokers with COHb levels >3% or subjects who have smoked within two (2) days. Subjects will be screened for COHb levels of >3% with a Masimo Radical 7 (Rainbow).
- Subjects with known respiratory conditions (uncontrolled asthma, head cold, flu, pneumonia / bronchitis, respiratory distress / respiratory or lung surgery, emphysema, COPD, lung disease),
- Subjects with known heart or cardiovascular conditions,
Show all 11Show fewer
- Female subjects that are actively trying to get pregnant or are pregnant,
- Subjects taking blood thinners or medications with aspirin or other antiplatelet medication in them (applies only to arterial draw study),
- Subjects with Systolic blood pressure >140mmHg,
- Subjects with Diastolic blood pressure >100mmHg,
- Subjects with heart rhythms other than a normal sinus rhythm or with respiratory sinus arrhythmia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: SpO2 System Accuracy Testing
A study to test the accuracy of SpO2 sensors with various patient monitors, co-oximeters, and modules.
Read the detailed description
The U-TruSignal with different sensors is feasible for noninvasive and continuous SpO2 monitoring and meets the specified measurement accuracy when compared to a co-oximetry gold reference.
- Conditions
- Pulse Oximetry
- Being tested
- Pulse oximetry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulse oximetryDevice
Pulse oximetry measurement using SpO2 sensors, patient monitors, co-oximeters, and various modules.
| Study group | Role | What they receive |
|---|---|---|
| Pulse oximetry monitoring | Experimental | The U-TruSignal with different sensors is feasible for noninvasive and continuous SpO2 monitoring and meets the specified measurement accuracy when compared to a co-oximetry gold reference. Receives: Device: Pulse oximetry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy Root Mean Square (ARMS)
The Accuracy Root Mean Square (ARMS) calculation is used to measure accuracy of the test SpO2 device compared to reference SpO2 device. A scatterplot is created with the forehead sensor saturation on the y-axis and the measured blood saturation on the x-axis. The line of identity is drawn representing the ideal points, meaning that the forehead sensor saturation is always the same as the blood saturation. The dispersion of the actual data points around the line of identity can be measured using a statistical calculation called Arithmetic Root Mean Square (ARMS). The smaller ARMs the closer the data points lie around the line of identity, representing a more accurate sensor as accurate and appropriate. Data analysis follows ISO 80601-2-61, 2011, Annex EE and the FDA Guidance Document for Pulse Oximeters (FDA Draft Guidance, July 19, 2007).
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2012 (estimated)
- Study start19 Jun 2012
- Primary completion15 Feb 2013
- Study completion15 Feb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pulse OximetryStudies of the same condition, open and under way.
- More trials run by GE HealthcareThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- GE Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeffrey Conner, Study director, GEHC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01613222
- Sponsor's protocol ID
- 118.02-2011-GES-0012
- Status last verified
- Jan 2019
- First submitted
- 5 Jun 2012
- Last updated
- 5 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SpO2 System Accuracy Testing
- ClinicalTrials.gov ID
- NCT01613222
- Acronym / sponsor ID
- 118.02-2011-GES-0012
- Conditions
- Pulse Oximetry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- GE HealthcareIndustry (pharma, biotech, devices)
- Study start
- 19 Jun 2012 (actual)
- Primary completion
- 15 Feb 2013 (actual)
- Study completion
- 15 Feb 2013 (actual)
- First posted
- 7 Jun 2012 (estimated)
- Results
- Posted 5 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study to test the accuracy of SpO2 sensors with various patient monitors, co-oximeters, and modules.
Detailed description
The U-TruSignal with different sensors is feasible for noninvasive and continuous SpO2 monitoring and meets the specified measurement accuracy when compared to a co-oximetry gold reference.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pulse oximetry monitoring | Experimental | Device: Pulse oximetryThe U-TruSignal with different sensors is feasible for noninvasive and continuous SpO2 monitoring and meets the specified measurement accuracy when compared to a co-oximetry gold reference. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Ability to provide written informed consent or have a legally authorized representative provide written informed consent
- Subjects who are 18-55 years of age
- Subjects must be willing and able to comply with study procedures
- HbCO<3% (for smokers only)
Key exclusion criteria (11 listed)
- Subject or a legally authorized representative is unable to provide written inform consent.
- Subjects that are considered morbidly obese (defined as BMI > 39.5),
- Subjects with injuries, deformities or abnormalities that may prevent proper application of the device under test,
- Smokers with COHb levels >3% or subjects who have smoked within two (2) days. Subjects will be screened for COHb levels of >3% with a Masimo Radical 7 (Rainbow).
- Subjects with known respiratory conditions (uncontrolled asthma, head cold, flu, pneumonia / bronchitis, respiratory distress / respiratory or lung surgery, emphysema, COPD, lung disease),
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 oximetryPulse oximetry measurement using SpO2 sensors, patient monitors, co-oximeters, and various modules. | Device | Pulse oximetry monitoring |
Primary outcome
Accuracy Root Mean Square (ARMS)
Time frame: 60 minutes
The Accuracy Root Mean Square (ARMS) calculation is used to measure accuracy of the test SpO2 device compared to reference SpO2 device. A scatterplot is created with the forehead sensor saturation on the y-axis and the measured blood saturation on the x-axis. The line of identity is drawn representing the ideal points, meaning that the forehead sensor saturation is always the same as the blood saturation. The dispersion of the actual data points around the line of identity can be measured using a statistical calculation called Arithmetic Root Mean Square (ARMS). The smaller ARMs the closer the data points lie around the line of identity, representing a more accurate sensor as accurate and appropriate. Data analysis follows ISO 80601-2-61, 2011, Annex EE and the FDA Guidance Document for Pulse Oximeters (FDA Draft Guidance, July 19, 2007).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Jeffrey Conner study director
GEHC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulse oximetry in people with Pulse Oximetry, run by GE Healthcare 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 11 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 5 Feb 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?
Yes. Results are posted in the registry (first posted 5 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Accuracy Root Mean Square (ARMS) (time frame: 60 minutes). 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 5 Feb 2019.