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Trial Outcomes & Findings for SpO2 Data Collection in Pediatric Patients Using INVSENSOR00061 (NCT NCT05896267)

NCT ID: NCT05896267

Last Updated: 2025-11-12

Results Overview

SpO2 accuracy will be determined by calculating the Arithmetic Root Mean Square (ARMs) value which will be reported as percent of oxygen saturated hemoglobin. The noninvasive oxygen saturation measurement (SpO2) from the INVSENSOR00061 will be compared to the noninvasive oxygen saturation measurement (SpO2) value from the RD SET Neo sensor.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

64 participants

Primary outcome timeframe

Approximately 15 minutes

Results posted on

2025-11-12

Participant Flow

Participant milestones

Participant milestones
Measure
Masimo INVSENSOR00061
Experimental: INVSENSOR00061 All subjects are enrolled into this arm will have noninvasive blood oxygen measurements obtained. Masimo INVSENSOR00061: Masimo INVSENSOR00061 will be used to measure noninvasive SpO2 (Oxygen Saturation )
Overall Study
STARTED
64
Overall Study
COMPLETED
60
Overall Study
NOT COMPLETED
4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

SpO2 Data Collection in Pediatric Patients Using INVSENSOR00061

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Masimo INVSENSOR00061
n=60 Participants
Experimental: INVSENSOR00061 All subjects are enrolled into this arm will have noninvasive blood oxygen measurements obtained. Masimo INVSENSOR00061: Masimo INVSENSOR00061 will be used to measure noninvasive SpO2 (Oxygen Saturation )
Age, Categorical
>=65 years
0 Participants
n=10 Participants
Age, Categorical
<=18 years
60 Participants
n=10 Participants
Age, Categorical
Between 18 and 65 years
0 Participants
n=10 Participants
Sex: Female, Male
Female
25 Participants
n=10 Participants
Sex: Female, Male
Male
35 Participants
n=10 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
32 Participants
n=10 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
27 Participants
n=10 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
1 Participants
n=10 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=10 Participants
Race (NIH/OMB)
Asian
3 Participants
n=10 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
2 Participants
n=10 Participants
Race (NIH/OMB)
Black or African American
14 Participants
n=10 Participants
Race (NIH/OMB)
White
38 Participants
n=10 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=10 Participants
Race (NIH/OMB)
Unknown or Not Reported
3 Participants
n=10 Participants
Region of Enrollment
United States
60 participants
n=10 Participants

PRIMARY outcome

Timeframe: Approximately 15 minutes

Population: 30 subjects were excluded from the analysis and replaced with new participants because of incorrect sensor placement.

SpO2 accuracy will be determined by calculating the Arithmetic Root Mean Square (ARMs) value which will be reported as percent of oxygen saturated hemoglobin. The noninvasive oxygen saturation measurement (SpO2) from the INVSENSOR00061 will be compared to the noninvasive oxygen saturation measurement (SpO2) value from the RD SET Neo sensor.

Outcome measures

Outcome measures
Measure
Masimo INVSENSOR00061
n=30 Participants
Experimental: INVSENSOR00061 All subjects are enrolled into this arm will have noninvasive blood oxygen measurements obtained. Masimo INVSENSOR00061: Masimo INVSENSOR00061 will be used to measure noninvasive SpO2 (Oxygen Saturation ) in blood .
SpO2 Accuracy of INVSENSOR00061
0.87 percent of oxygen saturated hemoglobin

PRIMARY outcome

Timeframe: Approximately 15 minutes

Population: 30 subjects were excluded from the analysis and replaced with new participants because of incorrect sensor placement.

Pulse Rate accuracy will be determined by calculating the Arithmetic Root Mean Square (ARMs) value through the comparison of the noninvasive Pulse Rate to the noninvasive Pulse Rate (PR) value obtained from the RD SET Neo sensor which will be reported as beats per minute.

Outcome measures

Outcome measures
Measure
Masimo INVSENSOR00061
n=30 Participants
Experimental: INVSENSOR00061 All subjects are enrolled into this arm will have noninvasive blood oxygen measurements obtained. Masimo INVSENSOR00061: Masimo INVSENSOR00061 will be used to measure noninvasive SpO2 (Oxygen Saturation ) in blood .
Pulse Rate Accuracy of INVSENSOR00061
4.45 beats per minute

Adverse Events

Masimo INVSENSOR00061

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Chelsea Frank

Masimo Corporation

Phone: 949-297-7000

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place

Restriction type: GT60