Trial Outcomes & Findings for Accuracy of Methemoglobin Measurement for Rainbow Universal Pulse Oximeter Sensor (NCT NCT03125005)

Results Overview

Accuracy willl be determined by comparing the noninvasive blood methemoglobin measurement (expressed as a percentage of total hemoglobin) of the pulse oximeter to that obtained from a blood sample and calculating the arithmetic root mean square(Arms) error value.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

51 participants

Primary outcome timeframe

5 hours

Results posted on

2017-07-27

Participant Flow

Participant milestones

Participant milestones
Measure	Rainbow Universal Pulse Oximeter Sensor All subjects will be enrolled in the test group and will receive Rainbow Universal Pulse Oximeter Sensor. Rainbow Universal Pulse Oximeter Sensor
Overall Study STARTED	51
Overall Study COMPLETED	51
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Accuracy of Methemoglobin Measurement for Rainbow Universal Pulse Oximeter Sensor

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Rainbow Universal Pulse Oximeter Sensor n=51 Participants All subjects will be enrolled in the test group and will receive Rainbow Universal Pulse Oximeter Sensor. Rainbow Universal Pulse Oximeter Sensor
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	51 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	29 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants
Region of Enrollment United States	51 participants n=5 Participants

PRIMARY outcome

Timeframe: 5 hours

Accuracy willl be determined by comparing the noninvasive blood methemoglobin measurement (expressed as a percentage of total hemoglobin) of the pulse oximeter to that obtained from a blood sample and calculating the arithmetic root mean square(Arms) error value.

Outcome measures

Outcome measures
Measure	Rainbow Universal Pulse Oximeter Sensor n=51 Participants All subjects will be enrolled in the test group and will receive Rainbow Universal Pulse Oximeter Sensor. Rainbow Universal Pulse Oximeter Sensor
Accuracy of Sensor by Arms Calculation	0.63 Percentage of total hemoglobin

Adverse Events

Rainbow Universal Pulse Oximeter 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