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Validate the performance of Philips FAST SpO2 with Masimo Pulse Oximetry Sensors in determining functional arterial oxygen saturation (SpO2) using arterial saturation (SaO2) as a reference in the range of 70-100% in subjects of varying skin pigmentation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Subject | Experimental | All subjects who are enrolled into the test group and participate in data collection have the Philips FAST SpO2 with Masimo Pulse Oximetry Sensors |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Philips FAST SpO2 with Masimo Pulse Oximetry Sensors | Device | Noninvasive pulse oximeter |
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| Measure | Description | Time Frame |
|---|---|---|
| Oxygen Saturation Performance of Philips FAST SpO₂ With Masimo Pulse Oximeter Sensor (RD SET® Adt) | The SpO₂ accuracy of Philips FAST SpO₂ with Masimo Pulse Oximeter Sensor (RD SET® Adt) was determined by calculating the accuracy root mean-squared (ARMS) difference between the measured values (SpO₂) to the reference values (SaO₂) in accordance with ISO-80601-2-61. ARMS is a standard statistical method used in pulse oximetry performance evaluations to quantify the overall accuracy of a device. Arms= √(∑(i=1 to n) ((SpO₂_i-SaO₂_i )^2 ))/n. Participants in this arm could receive one or more sensor types used for data collection. | 1 hour |
| Oxygen Saturation Performance of Philips FAST SpO₂ With Masimo Pulse Oximeter Sensor (RD SET® Adt CS) | The SpO₂ accuracy of Philips FAST SpO₂ with Masimo Pulse Oximeter Sensor (RD SET® Adt CS) was determined by calculating the accuracy root mean-squared (ARMS) difference between the measured values (SpO₂) to the reference values (SaO₂) in accordance with ISO-80601-2-61. ARMS is a standard statistical method used in pulse oximetry performance evaluations to quantify the overall accuracy of a device. Arms= √(∑(i=1 to n) ((SpO₂_i-SaO₂_i )^2 ))/n. Participants in this arm could receive one or more sensor types used for data collection. | 1 hour |
| Oxygen Saturation Performance of Philips FAST SpO₂ With Masimo Pulse Oximeter Sensor (RD SET® YI) | The SpO₂ accuracy of Philips FAST SpO₂ with Masimo Pulse Oximeter Sensor (RD SET® YI) was determined by calculating the accuracy root mean-squared (ARMS) difference between the measured values (SpO₂) to the reference values (SaO₂) in accordance with ISO-80601-2-61. ARMS is a standard statistical method used in pulse oximetry performance evaluations to quantify the overall accuracy of a device. Arms= √(∑(i=1 to n) ((SpO₂_i-SaO₂_i )^2 ))/n. Participants in this arm could receive one or more sensor types used for data collection. | 1 hour |
| Oxygen Saturation Performance of Philips FAST SpO₂ With Masimo Pulse Oximeter Sensor (RD SET® DBI) |
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Inclusion Criteria (Eligible Subjects):
Exclusion Criteria (Ineligible Subjects) (* = per clinician discretion):
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Masimo Corporation | Irvine | California | 92618 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Philips FAST SpO2 With Masimo Pulse Oximetry Sensors | All subjects who are enrolled into the test group and participate in data collection have the Philips FAST SpO2 with Masimo Pulse Oximetry Sensors Philips FAST SpO2 with Masimo Pulse Oximetry Sensors: Noninvasive pulse oximeter |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Philips FAST SpO2 With Masimo Pulse Oximetry Sensors | All subjects who are enrolled into the test group and participate in data collection have the Philips FAST SpO2 with Masimo Pulse Oximetry Sensors Philips FAST SpO2 with Masimo Pulse Oximetry Sensors: Noninvasive pulse oximeter |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Oxygen Saturation Performance of Philips FAST SpO₂ With Masimo Pulse Oximeter Sensor (RD SET® Adt) | The SpO₂ accuracy of Philips FAST SpO₂ with Masimo Pulse Oximeter Sensor (RD SET® Adt) was determined by calculating the accuracy root mean-squared (ARMS) difference between the measured values (SpO₂) to the reference values (SaO₂) in accordance with ISO-80601-2-61. ARMS is a standard statistical method used in pulse oximetry performance evaluations to quantify the overall accuracy of a device. Arms= √(∑(i=1 to n) ((SpO₂_i-SaO₂_i )^2 ))/n. Participants in this arm could receive one or more sensor types used for data collection. | The study was run in multiple rounds to accommodate different sensor types. Of the total 67 subjects, 25 participants were included in RD SET® Adt sensor analysis, as they received this sensor and met the minimum criteria of 24 subjects for the study. | Posted | Number | % of oxygen saturated hemoglobin | 1 hour |
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1 hour
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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 | Test Subject | All subjects who are enrolled into the test group and participate in data collection have the Philips FAST SpO2 with Masimo Pulse Oximetry Sensors Philips FAST SpO2 with Masimo Pulse Oximetry Sensors: Noninvasive pulse oximeter |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lightheadedness | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ahmed Alghazi | Masimo Corporation | 949-297-7000 | studies@masimo.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 10, 2023 | Jan 13, 2026 | Prot_SAP_000.pdf |
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The SpO₂ accuracy of Philips FAST SpO₂ with Masimo Pulse Oximeter Sensor (RD SET® DBI) was determined by calculating the accuracy root mean-squared (ARMS) difference between the measured values (SpO₂) to the reference values (SaO₂) in accordance with ISO-80601-2-61. ARMS is a standard statistical method used in pulse oximetry performance evaluations to quantify the overall accuracy of a device.
Arms= √(∑(i=1 to n) ((SpO₂_i-SaO₂_i )^2 ))/n.
Participants in this arm could receive one or more sensor types used for data collection.
| 1 hour |
| Oxygen Saturation Performance of Philips FAST SpO₂ With Masimo Pulse Oximeter Sensor (LNCS® Adtx) | The SpO₂ accuracy of Philips FAST SpO₂ with Masimo Pulse Oximeter Sensor (LNCS® Adtx) was determined by calculating the accuracy root mean-squared (ARMS) difference between the measured values (SpO₂) to the reference values (SaO₂) in accordance with ISO-80601-2-61. ARMS is a standard statistical method used in pulse oximetry performance evaluations to quantify the overall accuracy of a device. Arms= √(∑(i=1 to n) ((SpO₂_i-SaO₂_i )^2 ))/n. Participants in this arm could receive one or more sensor types used for data collection. | 1 hour |
| Oxygen Saturation Performance of Philips FAST SpO₂ With Masimo Pulse Oximeter Sensor (RD SET® TC-I) | The SpO₂ accuracy of Philips FAST SpO₂ with Masimo Pulse Oximeter Sensor (RD SET® TC-I) was determined by calculating the accuracy root mean-squared (ARMS) difference between the measured values (SpO₂) to the reference values (SaO₂) in accordance with ISO-80601-2-61. ARMS is a standard statistical method used in pulse oximetry performance evaluations to quantify the overall accuracy of a device. Arms= √(∑(i=1 to n) ((SpO₂_i-SaO₂_i )^2 ))/n. Participants in this arm could receive one or more sensor types used for data collection. | 1 hour |
| Oxygen Saturation Performance of Philips FAST SpO₂ With Masimo Pulse Oximeter Sensor (RD SET® DCI) | The SpO₂ accuracy of Philips FAST SpO₂ with Masimo Pulse Oximeter Sensor (RD SET® DCI) was determined by calculating the accuracy root mean-squared (ARMS) difference between the measured values (SpO₂) to the reference values (SaO₂) in accordance with ISO-80601-2-61. ARMS is a standard statistical method used in pulse oximetry performance evaluations to quantify the overall accuracy of a device. Arms= √(∑(i=1 to n) ((SpO₂_i-SaO₂_i )^2 ))/n. Participants in this arm could receive one or more sensor types used for data collection. | 1 hour |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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All subjects who are enrolled into the test group and participate in data collection have the Philips FAST SpO₂ with Masimo Pulse Oximetry Sensors Philips FAST SpO₂ with Masimo Pulse Oximetry Sensors: Noninvasive pulse oximeter |
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| Primary | Oxygen Saturation Performance of Philips FAST SpO₂ With Masimo Pulse Oximeter Sensor (RD SET® Adt CS) | The SpO₂ accuracy of Philips FAST SpO₂ with Masimo Pulse Oximeter Sensor (RD SET® Adt CS) was determined by calculating the accuracy root mean-squared (ARMS) difference between the measured values (SpO₂) to the reference values (SaO₂) in accordance with ISO-80601-2-61. ARMS is a standard statistical method used in pulse oximetry performance evaluations to quantify the overall accuracy of a device. Arms= √(∑(i=1 to n) ((SpO₂_i-SaO₂_i )^2 ))/n. Participants in this arm could receive one or more sensor types used for data collection. | The study was run in multiple rounds to accommodate different sensor types. Of the total 67 subjects, 25 participants were included in RD SET® Adt CS sensor analysis, as they received this sensor and met the minimum criteria of 24 subjects for the study. | Posted | Number | % of oxygen saturated hemoglobin | 1 hour |
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| Primary | Oxygen Saturation Performance of Philips FAST SpO₂ With Masimo Pulse Oximeter Sensor (RD SET® YI) | The SpO₂ accuracy of Philips FAST SpO₂ with Masimo Pulse Oximeter Sensor (RD SET® YI) was determined by calculating the accuracy root mean-squared (ARMS) difference between the measured values (SpO₂) to the reference values (SaO₂) in accordance with ISO-80601-2-61. ARMS is a standard statistical method used in pulse oximetry performance evaluations to quantify the overall accuracy of a device. Arms= √(∑(i=1 to n) ((SpO₂_i-SaO₂_i )^2 ))/n. Participants in this arm could receive one or more sensor types used for data collection. | The study was run in multiple rounds to accommodate different sensor types. Of the total 67 subjects, 24 participants were included in RD SET® YI sensor analysis, as they received this sensor and met the minimum criteria of 24 subjects for the study. | Posted | Number | % of oxygen saturated hemoglobin | 1 hour |
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| Primary | Oxygen Saturation Performance of Philips FAST SpO₂ With Masimo Pulse Oximeter Sensor (RD SET® DBI) | The SpO₂ accuracy of Philips FAST SpO₂ with Masimo Pulse Oximeter Sensor (RD SET® DBI) was determined by calculating the accuracy root mean-squared (ARMS) difference between the measured values (SpO₂) to the reference values (SaO₂) in accordance with ISO-80601-2-61. ARMS is a standard statistical method used in pulse oximetry performance evaluations to quantify the overall accuracy of a device. Arms= √(∑(i=1 to n) ((SpO₂_i-SaO₂_i )^2 ))/n. Participants in this arm could receive one or more sensor types used for data collection. | The study was run in multiple rounds to accommodate different sensor types. Of the total 67 subjects, 25 participants were included in RD SET® DBI sensor analysis, as they received this sensor and met the minimum criteria of 24 subjects for the study. | Posted | Number | % of oxygen saturated hemoglobin | 1 hour |
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| Primary | Oxygen Saturation Performance of Philips FAST SpO₂ With Masimo Pulse Oximeter Sensor (LNCS® Adtx) | The SpO₂ accuracy of Philips FAST SpO₂ with Masimo Pulse Oximeter Sensor (LNCS® Adtx) was determined by calculating the accuracy root mean-squared (ARMS) difference between the measured values (SpO₂) to the reference values (SaO₂) in accordance with ISO-80601-2-61. ARMS is a standard statistical method used in pulse oximetry performance evaluations to quantify the overall accuracy of a device. Arms= √(∑(i=1 to n) ((SpO₂_i-SaO₂_i )^2 ))/n. Participants in this arm could receive one or more sensor types used for data collection. | The study was run in multiple rounds to accommodate different sensor types. Of the total 67 subjects, 28 participants were included in LNCS® Adtx sensor analysis, as they received this sensor and met the minimum criteria of 24 subjects for the study. | Posted | Number | % of oxygen saturated hemoglobin | 1 hour |
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| Primary | Oxygen Saturation Performance of Philips FAST SpO₂ With Masimo Pulse Oximeter Sensor (RD SET® TC-I) | The SpO₂ accuracy of Philips FAST SpO₂ with Masimo Pulse Oximeter Sensor (RD SET® TC-I) was determined by calculating the accuracy root mean-squared (ARMS) difference between the measured values (SpO₂) to the reference values (SaO₂) in accordance with ISO-80601-2-61. ARMS is a standard statistical method used in pulse oximetry performance evaluations to quantify the overall accuracy of a device. Arms= √(∑(i=1 to n) ((SpO₂_i-SaO₂_i )^2 ))/n. Participants in this arm could receive one or more sensor types used for data collection. | The study was run in multiple rounds to accommodate different sensor types. Of the total 67 subjects, 28 participants were included in RD SET® TC-I sensor analysis, as they received this sensor and met the minimum criteria of 24 subjects for the study. | Posted | Number | % of oxygen saturated hemoglobin | 1 hour |
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| Primary | Oxygen Saturation Performance of Philips FAST SpO₂ With Masimo Pulse Oximeter Sensor (RD SET® DCI) | The SpO₂ accuracy of Philips FAST SpO₂ with Masimo Pulse Oximeter Sensor (RD SET® DCI) was determined by calculating the accuracy root mean-squared (ARMS) difference between the measured values (SpO₂) to the reference values (SaO₂) in accordance with ISO-80601-2-61. ARMS is a standard statistical method used in pulse oximetry performance evaluations to quantify the overall accuracy of a device. Arms= √(∑(i=1 to n) ((SpO₂_i-SaO₂_i )^2 ))/n. Participants in this arm could receive one or more sensor types used for data collection. | The study was run in multiple rounds to accommodate different sensor types. Of the total 67 subjects, 28 participants were included in RD SET® DCI sensor analysis, as they received this sensor and met the minimum criteria of 24 subjects for the study. | Posted | Number | % of oxygen saturated hemoglobin | 1 hour |
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| 0 |
| 70 |
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| 70 |
| 18 |
| 70 |
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
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| Tachycardia | Cardiac disorders | Non-systematic Assessment |
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| Numbness | Nervous system disorders | Non-systematic Assessment |
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| Hypotension | Vascular disorders | Non-systematic Assessment |
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| Abnormal Laboratory Finding | Investigations | Non-systematic Assessment |
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