SpO2SpO2 DispoNCT06211530
Wireless Disposable SpO2 Sensor Hypoxia Testing
A study testing SpO2 Sensor Testing in people with SpO2 and Peripheral Oxygen Saturation Measurement, run by GE Healthcare at 1 site in United States.
Trial summary
The purpose of the study is to collect SpO2 data with simultaneous transfer standard SpO2 measurements data on human participants. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- SpO2, Peripheral Oxygen Saturation Measurement
- What is being tested?
- SpO2 Sensor Testing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jan 2024to 8 Feb 2024
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participant is adult 18-50 years of age.
- Biological Male or female of any race
- Participant is a non-smoker or who has not smoked within 2 days prior.
- Participant must have the ability to understand and provide written informed consent.
- Participant is adult must be willing and able to comply with study procedures and duration.
Who cannot join
- Participant is considered as being morbidly obese (defined as BMI greater than 39.5)
- Compromised circulation (i.e., Raynaud's Syndrome), injury, or physical malformation of fingers, toes, hands, ears or forehead/skull or other sensor sites which would limit the ability to test sites needed for the study. (Note: Certain malformations may still allow participants to participate if the condition is noted and would not affect the particular sites utilized).
- Tattoo in the optical path which would limit the ability to test sites needed for the study.
- Females who are pregnant - confirmed by self-performed and self-reported positive urine pregnancy test performed on the day of the study unless the participant is known to be not of child-bearing potential
- Participants who have smoked in the last 2 days or participants who have refrained, for at least 48 hours, with COHb levels greater than 3% as assessed per site standard operation procedure.
- Participants with self-reported respiratory conditions such as: uncontrolled/severe asthma, flu, pneumonia/bronchitis, shortness of breath/respiratory distress, unresolved respiratory or lung surgery, emphysema, COPD, lung disease, and/or recent COVID (last 2 months).
Show all 9Show fewer
- Participants with self-reported heart or cardiovascular conditions such as: cardiovascular surgery - except successful minor surgery without clinical symptoms (i.e., PFO, PDA), chest pain (angina), previous heart attack, blocked artery, unexplained shortness of breath, congestive heart failure (CHF), history of stroke, transient ischemic attack, carotid artery disease, myocardial ischemia, myocardial infarction, cardiomyopathy, Cardiovascular implantable active medical device (such as pacemaker or automatic defibrillator), Heart rhythms other than a normal sinus rhythm or with respiratory sinus arrhythmia, and/or High blood pressure: systolic greater than140 mmHg or diastolic greater than 90 mmHg on 3 consecutive readings
- Participants with self-reported health conditions such as: diabetes, uncontrolled thyroid disease, kidney disease/chronic renal impairment, history of seizures (except childhood febrile seizures), epilepsy, history of unexplained syncope, recent history of frequent migraine headaches, recent symptomatic head injury (within the last 2 months), Cancer requiring chemotherapy, radiation, or currently on treatment, Participants with self-reported known clotting disorders, history of bleeding disorders or personal history of prolonged bleeding from injury, history of blood clots, hemophilia, current use of blood thinner: prescription or daily use of aspirin, and/or Sickle Cell Trait or Disease.
- 10. Participants with severe contact allergies to standard adhesives, latex, silicone, or other materials found in pulse oximetry sensors, ECG electrodes, respiration monitor electrodes or other medical sensors (self-reported) 11. Unwillingness or inability to remove colored nail polish or non-clear artificial nails from test digits 12. Surgical hardware in pathway which would limit the ability to test sites needed for the study 13. Other known health condition, should be considered upon disclosure in health assessment form.
Trial locations and contacts
1 site in 1 country.
United States1 site
Element Materials Technology
Louisville, Colorado, 80027
About this study
The purpose of the study is to collect SpO2 data with simultaneous transfer standard SpO2 measurements data on human participants.
Read the detailed description
The primary objective of the study is to collect SpO2 data with simultaneous transfer standard SpO2 measurements data (simulating blood sample Spo2) on adult human subjects. Transfer standard is a validated pulse oximetry equipment with a calibration directly traceable to CO-oximetry. Test method and protocol is developed according to ISO 80601-2-61:2017 annex EE.3 (PROCEDURE for non-invasive laboratory testing on healthy adult volunteers) The safety objective is to collect safety information, including type and number of AEs, SAEs, and device issues.
This is a pre-market, open label, prospective, non-randomized clinical research study conducted at one site in the United States.
- Conditions
- SpO2, Peripheral Oxygen Saturation Measurement
- Being tested
- SpO2 Sensor Testing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpO2 Sensor TestingDevice
Participants participating in this study will be connected sensors.The participants are exposed to a desaturation protocol. The protocol is consistent with the ISO 80601-2-61 pulse oximetry standard.
| Study group | Role | What they receive |
|---|---|---|
| SpO2 Measurements - All Subjects | Experimental | Participants participating in this study will be connected to sensors. The participants are exposed to a desaturation protocol. The protocol is consistent with the ISO 80601-2-61 pulse oximetry standard. Receives: Device: SpO2 Sensor Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Collection of Subject SpO2 Percentage Sensor Data With Transfer Standard Measurements for Validation
The collection of SpO2 percentage sensor data with simultaneous transfer standard SpO2 percentage measurements (simulating blood sample SpO2) from each subject enrolled in the study.
Measured: 2 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2024
- Study start30 Jan 2024
- Primary completion8 Feb 2024
- Study completion8 Feb 2024
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.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for SpO2Studies 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- GE Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Monica Rabanal, NP, Principal investigator, Element Materials Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06211530
- Sponsor's protocol ID
- 2023-061-MS-GES
- Acronym
- SpO2 Dispo
- Status last verified
- Mar 2025
- First submitted
- 9 Jan 2024
- Last updated
- 30 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Foglia EE, Whyte RK, Chaudhary A, Mott A, Chen J, Propert KJ, Schmidt B. The Effect of Skin Pigmentation on the Accuracy of Pulse Oximetry in Infants with Hypoxemia. J Pediatr. 2017 Mar;182:375-377.e2. doi: 10.1016/j.jpeds.2016.11.043. Epub 2016 Dec 9.
PubMed 27939107Tin W, Lal M. Principles of pulse oximetry and its clinical application in neonatal medicine. Semin Fetal Neonatal Med. 2015 Jun;20(3):192-7. doi: 10.1016/j.siny.2015.01.006. Epub 2015 Feb 18.
PubMed 25704605Gehring H, Duembgen L, Peterlein M, Hagelberg S, Dibbelt L. Hemoximetry as the "gold standard"? Error assessment based on differences among identical blood gas analyzer devices of five manufacturers. Anesth Analg. 2007 Dec;105(6 Suppl):S24-S30. doi: 10.1213/01.ane.0000268713.58174.cc.
PubMed 18048894Batchelder PB, Raley DM. Maximizing the laboratory setting for testing devices and understanding statistical output in pulse oximetry. Anesth Analg. 2007 Dec;105(6 Suppl):S85-S94. doi: 10.1213/01.ane.0000268495.35207.ab.
PubMed 18048904Fouzas S, Priftis KN, Anthracopoulos MB. Pulse oximetry in pediatric practice. Pediatrics. 2011 Oct;128(4):740-52. doi: 10.1542/peds.2011-0271. Epub 2011 Sep 19.
PubMed 21930554
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wireless Disposable SpO2 Sensor Hypoxia Testing
- ClinicalTrials.gov ID
- NCT06211530
- Acronym / sponsor ID
- SpO2 Dispo / 2023-061-MS-GES
- Conditions
- SpO2, Peripheral Oxygen Saturation Measurement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- GE HealthcareIndustry (pharma, biotech, devices)
- Study start
- 30 Jan 2024 (actual)
- Primary completion
- 8 Feb 2024 (actual)
- Study completion
- 8 Feb 2024 (actual)
- First posted
- 18 Jan 2024 (actual)
- Results
- Posted 30 Apr 2025
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 collect SpO2 data with simultaneous transfer standard SpO2 measurements data on human participants.
Detailed description
The primary objective of the study is to collect SpO2 data with simultaneous transfer standard SpO2 measurements data (simulating blood sample Spo2) on adult human subjects. Transfer standard is a validated pulse oximetry equipment with a calibration directly traceable to CO-oximetry. Test method and protocol is developed according to ISO 80601-2-61:2017 annex EE.3 (PROCEDURE for non-invasive laboratory testing on healthy adult volunteers) The safety objective is to collect safety information, including type and number of AEs, SAEs, and device issues.
This is a pre-market, open label, prospective, non-randomized clinical research study conducted at one site in the United States.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SpO2 Measurements - All Subjects | Experimental | Device: SpO2 Sensor TestingParticipants participating in this study will be connected to sensors. The participants are exposed to a desaturation protocol. The protocol is consistent with the ISO 80601-2-61 pulse oximetry standard. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Participant is adult 18-50 years of age.
- Biological Male or female of any race
- Participant is a non-smoker or who has not smoked within 2 days prior.
- Participant must have the ability to understand and provide written informed consent.
- Participant is adult must be willing and able to comply with study procedures and duration.
Key exclusion criteria (9 listed)
- Participant is considered as being morbidly obese (defined as BMI greater than 39.5)
- Compromised circulation (i.e., Raynaud's Syndrome), injury, or physical malformation of fingers, toes, hands, ears or forehead/skull or other sensor sites which would limit the ability to test sites needed for the study. (Note: Certain malformations may still allow participants to participate if the condition is noted and would not affect the particular sites utilized).
- Tattoo in the optical path which would limit the ability to test sites needed for the study.
- Females who are pregnant - confirmed by self-performed and self-reported positive urine pregnancy test performed on the day of the study unless the participant is known to be not of child-bearing potential
- Participants who have smoked in the last 2 days or participants who have refrained, for at least 48 hours, with COHb levels greater than 3% as assessed per site standard operation procedure.
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 |
|---|---|---|
| SpO2 Sensor TestingParticipants participating in this study will be connected sensors.The participants are exposed to a desaturation protocol. The protocol is consistent with the ISO 80601-2-61 pulse oximetry standard. | Device | SpO2 Measurements - All Subjects |
Primary outcome
Collection of Subject SpO2 Percentage Sensor Data With Transfer Standard Measurements for Validation
Time frame: 2 Weeks
The collection of SpO2 percentage sensor data with simultaneous transfer standard SpO2 percentage measurements (simulating blood sample SpO2) from each subject enrolled in the study.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 27939107Foglia EE, Whyte RK, Chaudhary A, Mott A, Chen J, Propert KJ, Schmidt B. The Effect of Skin Pigmentation on the Accuracy of Pulse Oximetry in Infants with Hypoxemia. J Pediatr. 2017 Mar;182:375-377.e2. doi: 10.1016/j.jpeds.2016.11.043. Epub 2016 Dec 9.
- Background: PubMed 25704605Tin W, Lal M. Principles of pulse oximetry and its clinical application in neonatal medicine. Semin Fetal Neonatal Med. 2015 Jun;20(3):192-7. doi: 10.1016/j.siny.2015.01.006. Epub 2015 Feb 18.
- Background: PubMed 18048894Gehring H, Duembgen L, Peterlein M, Hagelberg S, Dibbelt L. Hemoximetry as the "gold standard"? Error assessment based on differences among identical blood gas analyzer devices of five manufacturers. Anesth Analg. 2007 Dec;105(6 Suppl):S24-S30. doi: 10.1213/01.ane.0000268713.58174.cc.
- Background: PubMed 18048904Batchelder PB, Raley DM. Maximizing the laboratory setting for testing devices and understanding statistical output in pulse oximetry. Anesth Analg. 2007 Dec;105(6 Suppl):S85-S94. doi: 10.1213/01.ane.0000268495.35207.ab.
- Background: PubMed 21930554Fouzas S, Priftis KN, Anthracopoulos MB. Pulse oximetry in pediatric practice. Pediatrics. 2011 Oct;128(4):740-52. doi: 10.1542/peds.2011-0271. Epub 2011 Sep 19.
- 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.
Monica Rabanal, NP principal investigator
Element Materials Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SpO2 Sensor Testing in people with SpO2 and Peripheral Oxygen Saturation Measurement, 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 5 inclusion and 9 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 30 Apr 2025. 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 30 Apr 2025). 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?
Collection of Subject SpO2 Percentage Sensor Data With Transfer Standard Measurements for Validation (time frame: 2 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06211530, which also lists 5 linked publications.
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 30 Apr 2025.