Trial Outcomes & Findings for Comparison of Noninvasive Hemoglobin Disposable Sensors (NCT NCT03125031)

Results Overview

Accuracy will be determined by comparing the noninvasive hemoglobin measurement of the pulse oximeter to the hemoglobin value obtained from a blood sample and calculating the arithmetic root mean square (Arms) error value. The accuracy results from both sensors will be assessed for equivalence

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

44 participants

Primary outcome timeframe

1-5 hours

Results posted on

2017-07-27

Participant Flow

Participant milestones

Participant milestones
Measure	Rainbow Adhesive Adult/Pediatric Sensor All subjects are enrolled into the test group and receive the Rainbow adhesive adult/pediatric sensors.	Rainbow Adhesive Adult/Neonatal Sensor All subjects are enrolled into the test group and receive the Rainbow adhesive adult/neonatal sensors.
Overall Study STARTED	44	44
Overall Study COMPLETED	44	44
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison of Noninvasive Hemoglobin Disposable Sensors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Rainbow Adhesive Adult/Pediatric and Adult/Neonatal Sensors n=44 Participants All subjects are enrolled into the test group and receive the Rainbow adhesive sensors (adult/pediatric and adult/neonatal sensors).
Age, Customized 18-38 years	44 Participants n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants
Sex: Female, Male Male	32 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1-5 hours

Accuracy will be determined by comparing the noninvasive hemoglobin measurement of the pulse oximeter to the hemoglobin value obtained from a blood sample and calculating the arithmetic root mean square (Arms) error value. The accuracy results from both sensors will be assessed for equivalence

Outcome measures

Outcome measures
Measure	Group-Sensor 1 n=691 data points All subjects are enrolled into the test group and receive the Rainbow adhesive adult/pediatric sensors.	Group-Sensor 2 n=928 data points All subjects are enrolled into the test group and receive the Rainbow adhesive adult/neonatal sensors.
Accuracy of Noninvasive Sensors by Arms Calculation	1.0 g/dL	1.0 g/dL

Adverse Events

Rainbow Adhesive Adult/Pediatric and Adult/Neonatal Sensors

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

Tala Harake

Masimo

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place