Trial Outcomes & Findings for Effect of Skin Pigmentation and Race/Ethnicity Factors on the Accuracy of Masimo Pulse Oximeters (NCT NCT04889222)
NCT ID: NCT04889222
Last Updated: 2022-12-01
Results Overview
Performance of the INVSENSOR00050 sensor will be determined by comparing the noninvasive oxygen saturation measurement (SpO2) of the pulse oximeter sensors to the arterial oxygen saturation (SaO2) value obtained from a reference blood sample and calculating the accuracy root mean square (ARMS) value. The ARMS value will be reported as % of oxygen saturated hemoglobin.
TERMINATED
54 participants
1-5 hours
2022-12-01
Participant Flow
Participant milestones
| Measure |
Pulse Oximeters
All subjects who are enrolled into the test group and participate in data collection receive the noninvasive pulse oximeter sensors.
INVSENSOR00050: Noninvasive pulse oximeter sensor
RD SET SpO2: Noninvasive pulse oximeter sensor
|
|---|---|
|
Overall Study
STARTED
|
54
|
|
Overall Study
COMPLETED
|
38
|
|
Overall Study
NOT COMPLETED
|
16
|
Reasons for withdrawal
| Measure |
Pulse Oximeters
All subjects who are enrolled into the test group and participate in data collection receive the noninvasive pulse oximeter sensors.
INVSENSOR00050: Noninvasive pulse oximeter sensor
RD SET SpO2: Noninvasive pulse oximeter sensor
|
|---|---|
|
Overall Study
Did not meet eligibility criteria
|
8
|
|
Overall Study
Failure to place intravenous or arterial line
|
3
|
|
Overall Study
Did not proceed due to time constraints
|
5
|
Baseline Characteristics
Effect of Skin Pigmentation and Race/Ethnicity Factors on the Accuracy of Masimo Pulse Oximeters
Baseline characteristics by cohort
| Measure |
Pulse Oximeters
n=38 Participants
All subjects who are enrolled into the test group and participate in data collection receive the noninvasive pulse oximeter sensors.
INVSENSOR00050: Noninvasive pulse oximeter sensor
RD SET SpO2: Noninvasive pulse oximeter sensor
|
|---|---|
|
Age, Customized
< 18 years of age
|
0 Participants
n=99 Participants
|
|
Age, Customized
18 to 50 years of age
|
38 Participants
n=99 Participants
|
|
Age, Customized
> 50 years of age
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
17 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
18 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Black or African American
|
1 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Caucasian/Black or African American
|
1 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Native American/Black or African American
|
1 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 1-5 hoursPerformance of the INVSENSOR00050 sensor will be determined by comparing the noninvasive oxygen saturation measurement (SpO2) of the pulse oximeter sensors to the arterial oxygen saturation (SaO2) value obtained from a reference blood sample and calculating the accuracy root mean square (ARMS) value. The ARMS value will be reported as % of oxygen saturated hemoglobin.
Outcome measures
| Measure |
Pulse Oximeters
n=38 Participants
All subjects who are enrolled into the test group and participate in data collection receive the noninvasive pulse oximeter sensors.
INVSENSOR00050: Noninvasive pulse oximeter sensor
RD SET SpO2: Noninvasive pulse oximeter sensor
|
|---|---|
|
Oxygen Saturation (SpO2) Accuracy of INVSENSOR00050
|
1.5 % of oxygen saturated hemoglobin
|
SECONDARY outcome
Timeframe: 1-5 hoursPopulation: Due to early termination of the study, the subgroups were not well balanced for secondary outcomes analysis due to lack for female subjects, especially dark skin pigmented females. Hence the analysis is not fully representative. However, the equivalence analysis was conducted for the two pigment subgroups with available data.
The secondary outcome is to perform equivalence tests between identified subgroups based on skin pigmentation and/or self-identified race/ethnicity. Since the pulse oximeter displays saturation in integer values, equivalence limits will be set to ± 1% SpO2. A TOST procedure using the Wilcoxon Rank Sum Test was used to test the hypothesis that the median biases of the INVSENSOR00050 sensor from two pigmentation subgroups (Light and Dark) were equivalent within ± 1% SpO2. The TOST procedure provides a p-value indicating whether the two measures are equivalent if the p-value is less than 0.05.
Outcome measures
| Measure |
Pulse Oximeters
n=38 Participants
All subjects who are enrolled into the test group and participate in data collection receive the noninvasive pulse oximeter sensors.
INVSENSOR00050: Noninvasive pulse oximeter sensor
RD SET SpO2: Noninvasive pulse oximeter sensor
|
|---|---|
|
Comparison of the Median Bias Between Subgroups for the INVSENSOR00050 Sensor
Dark pigmented subgroup
|
-0.1 percentage of SpO2
Interval -0.2 to 0.0
|
|
Comparison of the Median Bias Between Subgroups for the INVSENSOR00050 Sensor
Light pigmented subgroup
|
-1.0 percentage of SpO2
Interval -1.0 to -0.9
|
SECONDARY outcome
Timeframe: 1-5 hoursPopulation: Due to early termination of the study, the subgroups were not well balanced for secondary outcomes analysis due to lack for female subjects, especially dark skin pigmented females. Hence the analysis is not fully representative. However, the equivalence analysis was conducted for the two pigment subgroups with available data.
The secondary outcome is to perform equivalence tests between identified subgroups based on skin pigmentation and/or self-identified race/ethnicity. Since the pulse oximeter displays saturation in integer values, equivalence limits will be set to ± 1% SpO2. A TOST procedure using the Wilcoxon Rank Sum Test was used to test the hypothesis that the median biases of the RD SET SpO2 sensor from two pigmentation subgroups (Light and Dark) were equivalent within ± 1 %SpO2. The TOST procedure provides a p-value indicating whether the two measures are equivalent if the p-value is less than 0.05.
Outcome measures
| Measure |
Pulse Oximeters
n=38 Participants
All subjects who are enrolled into the test group and participate in data collection receive the noninvasive pulse oximeter sensors.
INVSENSOR00050: Noninvasive pulse oximeter sensor
RD SET SpO2: Noninvasive pulse oximeter sensor
|
|---|---|
|
Comparison of the Median Bias Between Subgroups for the RD SET SpO2 Sensors
Dark pigmented subgroup
|
-0.3 percentage of SpO2
Interval -0.4 to -0.2
|
|
Comparison of the Median Bias Between Subgroups for the RD SET SpO2 Sensors
Light pigmented subgroup
|
-0.9 percentage of SpO2
Interval -1.0 to -0.8
|
Adverse Events
Pulse Oximeters
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Pulse Oximeters
n=38 participants at risk
All subjects who are enrolled into the test group and participate in data collection receive the noninvasive pulse oximeter sensors.
INVSENSOR00050: Noninvasive pulse oximeter sensor
RD SET SpO2: Noninvasive pulse oximeter sensor
|
|---|---|
|
Injury, poisoning and procedural complications
Blood vessel was potentially damaged during venipuncture.
|
2.6%
1/38 • 1 to 5 hours
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place