Trial Outcomes & Findings for Accuracy of Noninvasive Hemoglobin Sensor (Rainbow Reusable DCI) (NCT NCT03124758)

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

354 participants

Primary outcome timeframe

1-5 hours

Results posted on

2017-07-27

Participant Flow

Participant milestones

Participant milestones
Measure	Noninvasive Hemoglobin Sensor All subjects are enrolled into the test group and all subjects received the Noninvasive Hemoglobin Sensor (Rainbow Reusable DCI, DCIP)
Overall Study STARTED	354
Overall Study COMPLETED	354
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Accuracy of Noninvasive Hemoglobin Sensor (Rainbow Reusable DCI)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Noninvasive Hemoglobin Sensor n=354 Participants All subjects are enrolled into the test group and all subjects received the Noninvasive Hemoglobin Sensor (Rainbow Reusable DCI, DCIP)
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	354 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	127 Participants n=5 Participants
Sex: Female, Male Male	227 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.

Outcome measures

Outcome measures
Measure	Noninvasive Hemoglobin Sensor n=1990 data points All subjects are enrolled into the test group and all subjects received the Noninvasive Hemoglobin Sensor (Rainbow Reusable DCI, DCIP)
Accuracy of Sensor by Arms Calculation	1.0 g/dL

Adverse Events

Noninvasive Hemoglobin 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