Trial Outcomes & Findings for Accuracy of Noninvasive Hemoglobin Pulse Oximeter (Rainbow Resposable Adhesive Sensors) (NCT NCT03124771)

Results Overview

Accuracy willl 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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

132 participants

Primary outcome timeframe

1-5 hours

Results posted on

2017-07-27

Participant Flow

Participant milestones

Participant milestones
Measure	Rainbow Resposable Adhesive Sensor All subjects are enrolled into the test group and all subjects received the Rainbow Resposable Adhesive Sensor.
Overall Study STARTED	132
Overall Study COMPLETED	132
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Accuracy of Noninvasive Hemoglobin Pulse Oximeter (Rainbow Resposable Adhesive Sensors)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Rainbow Resposable Adhesive Sensors n=132 Participants All subjects are enrolled into the test group and all subjects received the Rainbow Resposable Adhesive Sensor.
Age, Customized 18-40 years	132 Participants n=93 Participants
Sex: Female, Male Female	65 Participants n=93 Participants
Sex: Female, Male Male	67 Participants n=93 Participants

PRIMARY outcome

Timeframe: 1-5 hours

Accuracy willl 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.

Outcome measures

Outcome measures
Measure	Rainbow Resposable Adhesive Sensor n=1345 data points All subjects are enrolled into the test group and all subjects received the Rainbow Resposable Adhesive Sensor.
Accuracy of Sensor by Arms Calculation	1.0 g/dL

Adverse Events

Rainbow Resposable Adhesive Sensor

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