Trial Outcomes & Findings for Accuracy of Noninvasive Pulse Oximeter Measurement of Hemoglobin for Rainbow DCI Sensor (NCT NCT03124901)

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

147 participants

Primary outcome timeframe

Up to 24 hours

Results posted on

2017-06-12

Participant Flow

Participant milestones

Participant milestones
Measure	Test Group All subject are enrolled into the test group and all subjects receive DCI pulse oximeter sensor.
Overall Study STARTED	147
Overall Study COMPLETED	147
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=147 Participants All subject are enrolled into the test group and all subjects receive DCI pulse oximeter sensor.
Age, Categorical <=18 years	0 Participants n=147 Participants
Age, Categorical Between 18 and 65 years	147 Participants n=147 Participants
Age, Categorical >=65 years	0 Participants n=147 Participants
Sex: Female, Male Female	43 Participants n=147 Participants
Sex: Female, Male Male	104 Participants n=147 Participants
Region of Enrollment United States	147 participants n=147 Participants

PRIMARY outcome

Timeframe: Up to 24 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	Test Group n=147 Participants All subject are enrolled into the test group and all subjects receive DCI pulse oximeter sensor.
Accuracy of Sensor	0.98 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