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The purpose of the study is to collect SpO2 data with simultaneous transfer standard SpO2 measurements data on human participants.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SpO2 Sensor Testing | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 Weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Safety Events | The collection of the number of adverse events, serious adverse events, and/or device deficiencies reported on all enrolled subjects in the study. | 2 Weeks |
Inclusion Criteria:
Exclusion Criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Monica Rabanal, NP | Element Materials Technology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Element Materials Technology | Louisville | Colorado | 80027 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27939107 | Background | 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. | |
| 25704605 | Background | Tin 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. |
| Label | URL |
|---|---|
| FDA -- U.S. Food and Drug Administration. Pulse Oximeters -- Premarket Notification Submissions \[510(k)s\] - Guidance for Industry and Food and Drug Administration Staff. March 4, 2013. | View source |
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A total of 32 participants were enrolled; 31 subjects completed all study procedures.
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| ID | Title | Description |
|---|---|---|
| FG000 | SpO2 Measurements - All Subjects | Participants participating in this study will be connected to eight (8) Portrait Mobile P-SA01PL/P-SP01PL prototype sensors provided by GEHC and two reference monitors, Nellcor N-600X V 1.6.0.0 and a forehead sensor, used as standard operating procedures at the site. Data will be collected using the Portrait Hub patient monitor. The participants are exposed to a desaturation protocol that sequentially decreases the SpO2 in a stepwise fashion. The goal is to achieve six stable oxygenation plateaus between 100 and 70% SpO2, while recording simultaneous SpO2 readings from the prototype and reference devices. The protocol is consistent with the ISO 80601-2-61 pulse oximetry standard. SpO2 Sensor Testing: Participants participating in this study will be connected to eight (8) Portrait Mobile P-SA01PL/P-SP01PL prototype sensors provided by GEHC and two reference monitors, Nellcor N-600X V 1.6.0.0 and a forehead sensor, used as standard operating procedures at the site. Data will be collected using the Portrait Hub patient monitor. The participants are exposed to a desaturation protocol that sequentially decreases the SpO2 in a stepwise fashion. The goal is to achieve six stable oxygenation plateaus between 100 and 70% SpO2, while recording simultaneous SpO2 readings from the prototype and reference devices. The protocol is consistent with the ISO 80601-2-61 pulse oximetry standard. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | SpO2 Measurements - All Subjects | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | data sets | 2 Weeks |
|
|
2 Weeks
All adverse events (AE), including all serious adverse events (SAE), are required to be collected, investigated, and documented. AEs will be collected from [describe the reporting period, e.g., from the time they enter the scan room to the time they leave the scan room]. All AEs will be followed through to their resolution.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Collection of Adverse Events | Collection of all information, including type and number of AEs, SAEs, and device issues. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| SAE | Cardiac disorders | Systematic Assessment | Cardiac arrithymia assessed during monitoring |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| AE | Cardiac disorders | Systematic Assessment | Cardiac arrithymia assessed during monitoring |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Principal Engineer | GE HealthCare | +358 (40) 7755194 | 100012917@gehealthcare.com |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_ICF | Yes | No | Yes | Study Protocol and Informed Consent Form | Jan 8, 2024 | Feb 19, 2025 | Prot_ICF_000.pdf |
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| 18048894 | Background | Gehring 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. |
| 18048904 | Background | Batchelder 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. |
| 21930554 | Background | Fouzas 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. |
| Participants |
| No |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Skin Pigment | Monk Skin Scale was used to to visually assess skin pigment at the forehead to assure enrolment of skin tone diversity. Higher numbers indicate darker skin tones. Lower numbers indicate lighter skin tones. | Number | Participants |
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| Other Pre-specified | Number of Safety Events | The collection of the number of adverse events, serious adverse events, and/or device deficiencies reported on all enrolled subjects in the study. | Posted | Number | safety events | 2 Weeks |
|
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|
| 0 |
| 32 |
| 1 |
| 32 |
| 1 |
| 32 |
|
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