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This is a prospective, non-randomized, single arm study design to evaluate SpO2 performance of the RD SET Neo investigational pulse oximeter sensors in the neonatal population using convenience sampling in a clinical environment. The initial subjects under Protocol Version 1 were enrolled as part of a feasibility study to verify the design changes to the sensor are correct. The study protocol was amended with Protocol Version 2 to enroll a group of subjects that will be used to evaluate clinical performance for submission to regulatory agencies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RD SET Neo SpO2 | Experimental | All subjects enrolled in the study will receive the investigational sensor (RD SET Neo SpO2) for evaluation of SpO2. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RD SET Neo SpO2 | Device | All subjects are enrolled in the experimental group and receive the RD SET Neo SpO2 sensor. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy of Oxygen Saturation (SpO2) Measurement by RMS Calculation | Accuracy will be determined by comparing the noninvasive blood oxygen saturation measurement of the pulse oximeter to that obtained from a blood sample and calculating the root mean square (RMS) error value. In order to obtain the RMS value, the blood oxygen saturation measurement form a laboratory pulse Co-Oximeter is subtracted from the pulse oximeter oxygen saturation measurement for each sample, the average of this difference is computed as the bias. The standard deviation of the differences is computed as the precision. The square root of the sum of the squares of bias and precision is computed as the RMS Error value. | up to 8 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University Medical Center | Stanford | California | 94305 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | RD SET Neo SpO2 | All subjects enrolled in the study will receive the investigational sensor (RD SET Neo SpO2) for evaluation of SpO2. RD SET Neo SpO2: All subjects are enrolled in the experimental group and receive the RD SET Neo SpO2 sensor. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | RD SET Neo SpO2 | All subjects enrolled in the study will receive the investigational sensor (RD SET Neo SpO2) for evaluation of SpO2. RD SET Neo SpO2: All subjects are enrolled in the experimental group and receive the RD SET Neo SpO2 sensor. |
| 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 | Accuracy of Oxygen Saturation (SpO2) Measurement by RMS Calculation | Accuracy will be determined by comparing the noninvasive blood oxygen saturation measurement of the pulse oximeter to that obtained from a blood sample and calculating the root mean square (RMS) error value. In order to obtain the RMS value, the blood oxygen saturation measurement form a laboratory pulse Co-Oximeter is subtracted from the pulse oximeter oxygen saturation measurement for each sample, the average of this difference is computed as the bias. The standard deviation of the differences is computed as the precision. The square root of the sum of the squares of bias and precision is computed as the RMS Error value. | Subject 7 & 11: Protocol deviation Subject 19 & 26: Outlier data points Subject 5: Removed per ISO standard for SpO2 equal to 100. | Posted | Number | percent of oxygen saturated hemoglobin | up to 8 hours |
|
1 day
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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 | RD SET Neo SpO2 | All subjects enrolled in the study will receive the investigational sensor (RD SET Neo SpO2) for evaluation of SpO2. RD SET Neo SpO2: All subjects are enrolled in the experimental group and receive the RD SET Neo SpO2 sensor. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vikram Ramakanth | Masimo | 949-297-7416 | clinicalresearchdept@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 | Aug 3, 2018 | Feb 4, 2020 | Prot_SAP_000.pdf |
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| Participants |
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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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All subjects enrolled in the study will receive the investigational sensor (RD SET Neo SpO2) for evaluation of SpO2.
RD SET Neo SpO2: All subjects are enrolled in the experimental group and receive the RD SET Neo SpO2 sensor.
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| 28 |
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| 28 |
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