Trial Outcomes & Findings for Spot-Check Noninvasive Hemoglobin (SpHb) Clinical Validation of INVSENSOR00026 (NCT NCT03610269)

Last Updated: 2019-06-25

Results Overview

Accuracy of the INVSENSOR00026 will be determined by comparing the noninvasive hemoglobin measurement (SpHb) of the INVSENSOR00026 to the hemoglobin value obtained from a reference blood sample and calculating the accuracy root mean square (Arms) error value. In order to obtain the Arms value, the blood sample hemoglobin value is subtracted from the INVSENSOR00026 hemoglobin value for a number of samples, the average of this difference is computed as the bias. The standard deviation of the differences is computed as the precision. The square root of the sum of the squares of bias and precision is computed as the Arms Error value.

Recruitment status

COMPLETED

Study phase

Target enrollment

143 participants

Primary outcome timeframe

Up to 2 hours per subject

Results posted on

2019-06-25

Participant Flow

Participant milestones

Participant milestones
Measure	INVSENSOR00026 All enrolled subjects receive INVSENSOR00026 Pulse CO-Oximeter and sensor for the noninvasive measurement of hemoglobin (SpHb).
Overall Study STARTED	143
Overall Study COMPLETED	127
Overall Study NOT COMPLETED	16

Reasons for withdrawal

Reasons for withdrawal
Measure	INVSENSOR00026 All enrolled subjects receive INVSENSOR00026 Pulse CO-Oximeter and sensor for the noninvasive measurement of hemoglobin (SpHb).
Overall Study Physician Decision	10
Overall Study Protocol Violation	1
Overall Study Unable to draw blood	1
Overall Study Screen fail	4

Baseline Characteristics

Spot-Check Noninvasive Hemoglobin (SpHb) Clinical Validation of INVSENSOR00026

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	INVSENSOR00026 n=111 Participants All enrolled subjects receive INVSENSOR00026 Pulse CO-Oximeter and sensor for the noninvasive measurement of hemoglobin (SpHb).
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	101 Participants n=99 Participants
Age, Categorical >=65 years	10 Participants n=99 Participants
Sex: Female, Male Female	68 Participants n=99 Participants
Sex: Female, Male Male	43 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=99 Participants
Race (NIH/OMB) Asian	1 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	3 Participants n=99 Participants
Race (NIH/OMB) White	106 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Region of Enrollment United States	111 participants n=99 Participants

PRIMARY outcome

Timeframe: Up to 2 hours per subject

Outcome measures

Outcome measures
Measure	INVSENSOR00026 n=111 Participants All enrolled subjects receive INVSENSOR00026 Pulse CO-Oximeter and sensor for the noninvasive measurement of hemoglobin (SpHb).
Accuracy of Noninvasive Hemoglobin (SpHb) Measurement by Arms Calculation	0.93 g/dL

Adverse Events

INVSENSOR00026

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	INVSENSOR00026 n=127 participants at risk All enrolled subjects receive INVSENSOR00026 Pulse CO-Oximeter and sensor for the noninvasive measurement of hemoglobin (SpHb).
Injury, poisoning and procedural complications Vasovagal syncope	0.79% 1/127 • During the duration of the study and 2 weeks after participation in the study.
Injury, poisoning and procedural complications Hematoma	0.79% 1/127 • During the duration of the study and 2 weeks after participation in the study.

Additional Information

Vikram Ramakanth

Masimo

Phone: 949-297-7416

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place