Trial Outcomes & Findings for Hemodilution Validation of INVSENSOR00026 (NCT NCT03677375)

NCT ID: NCT03677375

Last Updated: 2019-05-20

Results Overview

Accuracy will 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. In order to obtain the Arms value, the blood sample hemoglobin value is subtracted from the pulse oximeter 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: NA
• Target enrollment: 173 participants
• Primary outcome timeframe: 1-5 hours
• Results posted on: 2019-05-20

Participant Flow

Protocol enrollment number includes screen failures and subjects that did not proceed due to time constraints

Participant milestones

Measure	Test Subject All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00026. INVSENSOR00026: Noninvasive pulse oximeter sensor
Overall Study STARTED	93
Overall Study COMPLETED	81
Overall Study NOT COMPLETED	12

Reasons for withdrawal

Measure	Test Subject All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00026. INVSENSOR00026: Noninvasive pulse oximeter sensor
Overall Study Incomplete procedure	8
Overall Study Adverse Event	3
Overall Study Physician Decision	1

Baseline Characteristics

Hemodilution Validation of INVSENSOR00026

Baseline characteristics by cohort

Measure	Test Subject n=40 Participants All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00026. INVSENSOR00026: Noninvasive pulse oximeter sensor
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	40 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	31 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Race/Ethnicity, Customized Asian or Pacific Islander	4 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	15 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	12 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	9 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1-5 hours

Accuracy will 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. In order to obtain the Arms value, the blood sample hemoglobin value is subtracted from the pulse oximeter 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.

Outcome measures

Measure	Test Subject n=40 Participants All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00026. INVSENSOR00026: Noninvasive pulse oximeter sensor
Accuracy of Noninvasive Hemoglobin Sensor by Arms Calculation	1.13 g/dL

Adverse Events

Test Subject

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Test Subject n=93 participants at risk All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00026. INVSENSOR00026: Noninvasive pulse oximeter sensor
Injury, poisoning and procedural complications Swelling due to IV catheter site infiltration	2.2% 2/93 • 5 months
Injury, poisoning and procedural complications Vasovagal episode during arterial line placement	1.1% 1/93 • 5 months
Injury, poisoning and procedural complications Numbness secondary to local anesthetic infiltration	1.1% 1/93 • 5 months
Injury, poisoning and procedural complications Bruising and swelling at arterial site	2.2% 2/93 • 5 months
Injury, poisoning and procedural complications Headache	1.1% 1/93 • 5 months
Injury, poisoning and procedural complications Discomfort	1.1% 1/93 • 5 months

Additional Information

Tala Harake

Masimo

Phone: 9492977000

Email: studies@masimo.com

Results disclosure agreements

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