An interventional study of RD SET Neo SpO2 in Evaluation of SpO2 Performance, sponsored by Masimo Corporation. Completed at 1 site in United States. Open to participants aged Up to 1 Month, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-02-25.
Sponsored by Masimo Corporation · Not applicable, Interventional, and Other
This is a prospective, non-randomized, single arm study design to evaluate SpO2 performance of the INVSENSOR00024 sensors in the neonatal population in a clinical environment using convenience sampling.
Masimo Corporation is the lead sponsor of 103 studies on the registry; 1 is open to participants now.
Of its 78 completed or terminated interventional studies of FDA-regulated products, 65 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
All subjects enrolled in the study will receive the investigational sensor (RD SET Neo SpO2) for evaluation of SpO2.
Device: RD SET Neo SpO2
All subjects are enrolled in the experimental group and receive the RD SET Neo SpO2 sensor.
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.
Time frame: up to 12 hours
| Milestone | RD SET Neo SpO2 |
|---|---|
| Started | 12 |
| Completed | 11 |
| Not completed | 1 |
| Withdrew: Could not place sensor | 1 |
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.
| percent of oxygen saturated hemoglobin | RD SET Neo SpO2 |
|---|---|
| Accuracy of Oxygen Saturation (SpO2) Measurement by RMS Calculation | 3.5 |
Collected over 1 day. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| RD SET Neo SpO2 | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) |
| Age, Categorical(Participants) | RD SET Neo SpO2 |
|---|---|
| <=18 years | 12 |
| Between 18 and 65 years | 0 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | RD SET Neo SpO2 |
|---|---|
| Female | 7 |
| Male | 5 |
| Race (NIH/OMB)(Participants) | RD SET Neo SpO2 |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 2 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 8 |
| More than one race | 0 |
| Unknown or Not Reported | 2 |
| Region of Enrollment(participants) | RD SET Neo SpO2 |
|---|---|
| United States | 12 |
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This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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