Trial Outcomes & Findings for Comparison of Rainbow INVSENSOR00001 and Control SpHb Disposable Sensor Performance During Hemodilution (NCT NCT03273166)

Last Updated: 2020-10-26

Results Overview

Performance of the sensors will be determined by comparing the noninvasive hemoglobin measurement (SpHb) of the pulse oximeter sensors to the hemoglobin value obtained from a reference blood sample and calculating the accuracy root mean square(ARMS) value.

Recruitment status

COMPLETED

Study phase

Target enrollment

82 participants

Primary outcome timeframe

1-5 hours

Results posted on

2020-10-26

Participant Flow

Fingers were not randomized to the two interventions. All participants received both interventions in the exact same manner.

Participant milestones

Participant milestones
Measure	INVSENSOR00001 All subjects consented are enrolled into the test group and will receive the INVSENSOR00001 and the control sensor simultaneously on different fingers.
Overall Study STARTED	82
Overall Study COMPLETED	51
Overall Study NOT COMPLETED	31

Reasons for withdrawal

Reasons for withdrawal
Measure	INVSENSOR00001 All subjects consented are enrolled into the test group and will receive the INVSENSOR00001 and the control sensor simultaneously on different fingers.
Overall Study Withdrawn prior to Completion	31

Baseline Characteristics

Comparison of Rainbow INVSENSOR00001 and Control SpHb Disposable Sensor Performance During Hemodilution

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	INVSENSOR00001 n=51 Participants All subjects consented are enrolled into the test group and will receive the INVSENSOR00001 and the control sensor simultaneously on different fingers.
Age, Categorical <=18 years	1 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	50 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Sex: Female, Male Female	16 Participants n=93 Participants
Sex: Female, Male Male	35 Participants n=93 Participants
Race/Ethnicity, Customized Race/Ethnicity, Customized · Caucasian	17 Participants n=93 Participants
Race/Ethnicity, Customized Race/Ethnicity, Customized · Hispanic	16 Participants n=93 Participants
Race/Ethnicity, Customized Race/Ethnicity, Customized · Asian or Pacific Islander	3 Participants n=93 Participants
Race/Ethnicity, Customized Race/Ethnicity, Customized · Native American	2 Participants n=93 Participants
Race/Ethnicity, Customized Race/Ethnicity, Customized · Black or African American	13 Participants n=93 Participants
Race/Ethnicity, Customized Race/Ethnicity, Customized · Other	0 Participants n=93 Participants

PRIMARY outcome

Timeframe: 1-5 hours

Outcome measures

Outcome measures
Measure	INVSENSOR00001 n=51 Participants All subjects consented are enrolled into the test group and will receive the INVSENSOR00001 and the control sensor simultaneously on different fingers.	Control SpHb Sensor n=51 Participants All subjects consented are enrolled into the test group and will receive the INVSENSOR00001 and the control sensor simultaneously on different fingers.
Comparison of INVSENSOR00001 and Control SpHb Sensor by ARMS Calculation	0.9 g/dL	0.9 g/dL

Adverse Events

INVSENSOR00001

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	INVSENSOR00001 n=51 participants at risk All subjects consented are enrolled into the test group and will receive the INVSENSOR00001 and the control sensor simultaneously on different fingers.
Injury, poisoning and procedural complications Dizziness	2.0% 1/51 • 1 to 5 hours Adverse Events were not collected with respect to the interventions, only on participants as a whole.
Injury, poisoning and procedural complications Irregular EKG readings	2.0% 1/51 • 1 to 5 hours Adverse Events were not collected with respect to the interventions, only on participants as a whole.

Additional Information

Chelsea Frank

Masimo

Phone: (949) 297-7000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place