Trial Outcomes & Findings for Accuracy of Hemoglobin Measurement for Various Rainbow Pulse Oximeter Sensors (NCT NCT03124966)

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

118 participants

Primary outcome timeframe

1-3 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 will receive the pulse oximeter sensor.
Overall Study STARTED	118
Overall Study COMPLETED	118
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	Noninvasive Hemoglobin Sensor n=118 Participants All subjects are enrolled into the test group and all will receive the pulse oximeter sensor.
Age, Categorical <=18 years	0 Participants n=118 Participants
Age, Categorical Between 18 and 65 years	118 Participants n=118 Participants
Age, Categorical >=65 years	0 Participants n=118 Participants
Sex: Female, Male Female	40 Participants n=118 Participants
Sex: Female, Male Male	78 Participants n=118 Participants
Region of Enrollment United States	118 participants n=118 Participants

PRIMARY outcome

Timeframe: 1-3 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=118 Participants All subjects are enrolled into the test group and all will receive the pulse oximeter sensor.
Accuracy of Sensor by Arms Calculation	0.96 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

Vikram Ramakanth

Masimo

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60