Trial Outcomes & Findings for Accuracy of Noninvasive Hemoglobin Measurement (SpHb) Using Rainbow DCI Pulse Oximeter Sensor (NCT NCT03124693)

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

90 participants

Primary outcome timeframe

Up to 24 hours

Results posted on

2017-06-12

Participant Flow

Participant milestones

Participant milestones
Measure	Test Group All subjects are enrolled into the test group and all subjects received the Rainbow DCI pulse oximeter sensor. Rainbow DCI pulse oximeter sensor
Overall Study STARTED	90
Overall Study COMPLETED	90
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Test Group n=90 Participants All subjects are enrolled into the test group and all subjects received the Rainbow DCI pulse oximeter sensor. Rainbow DCI pulse oximeter sensor
Age, Categorical <=18 years	0 Participants n=90 Participants
Age, Categorical Between 18 and 65 years	90 Participants n=90 Participants
Age, Categorical >=65 years	0 Participants n=90 Participants
Sex: Female, Male Female	18 Participants n=90 Participants
Sex: Female, Male Male	72 Participants n=90 Participants
Region of Enrollment United States	90 participants n=90 Participants

PRIMARY outcome

Timeframe: Up to 24 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	Test Group n=90 Participants All subjects are enrolled into the test group and all subjects received the Rainbow DCI pulse oximeter sensor.
Accuracy of Sensor by Arms Calculation	0.9 g/dL

Adverse Events

Test Group

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

Vikram Ramakanth

Masimo

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60