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Trial Outcomes & Findings for Accuracy of Methemoglobin Measurement for Rainbow DCI Sensors (NCT NCT03124927)

NCT ID: NCT03124927

Last Updated: 2017-06-12

Results Overview

Accuracy will be determined by comparing the noninvasive blood methemoglobin measurement 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

25 participants

Primary outcome timeframe

5 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 receive DCI pulse oximeter sensor.
Overall Study
STARTED
25
Overall Study
COMPLETED
25
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=25 Participants
All subjects are enrolled into the test group and all subjects receive DCI pulse oximeter sensor.
Age, Categorical
<=18 years
0 Participants
n=25 Participants
Age, Categorical
Between 18 and 65 years
25 Participants
n=25 Participants
Age, Categorical
>=65 years
0 Participants
n=25 Participants
Sex: Female, Male
Female
9 Participants
n=25 Participants
Sex: Female, Male
Male
16 Participants
n=25 Participants
Region of Enrollment
United States
25 Participants
n=25 Participants

PRIMARY outcome

Timeframe: 5 hours

Accuracy will be determined by comparing the noninvasive blood methemoglobin measurement 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
Test Group
n=25 Participants
All subjects are enrolled into the test group and all subjects receive DCI pulse oximeter sensor.
Accuracy of Sensor by Arms Calculation
0.87 percentage

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 Corporation

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place

Restriction type: LTE60