Trial Outcomes & Findings for Validation Study of Mean Arterial Pressure (MAP) Parameter of Masimo INVSENSOR00073 (NCT NCT06334055)

Last Updated: 2025-07-10

Results Overview

Accuracy and precision of mean arterial pressure (MAP) measured by Masimo INVSENSOR00073 in comparison to radial arterial line.

Recruitment status

COMPLETED

Study phase

Target enrollment

101 participants

Primary outcome timeframe

1-5 hours.

Results posted on

2025-07-10

Participant milestones
Measure	Masimo INVSENSOR00073 All subjects who are enrolled into the test group and participate in data collection receive the noninvasive Masimo INVSENSOR00073 sensor. Masimo INVSENSOR00073: Noninvasive blood pressure monitor
Overall Study STARTED	101
Overall Study COMPLETED	25
Overall Study NOT COMPLETED	76

Reasons for withdrawal
Measure	Masimo INVSENSOR00073 All subjects who are enrolled into the test group and participate in data collection receive the noninvasive Masimo INVSENSOR00073 sensor. Masimo INVSENSOR00073: Noninvasive blood pressure monitor
Overall Study Adverse Event	4
Overall Study Disqualified	72

Validation Study of Mean Arterial Pressure (MAP) Parameter of Masimo INVSENSOR00073

Baseline characteristics by cohort
Measure	Test Subject n=25 Participants All subjects who are enrolled into the test group and participate in data collection receive the noninvasive Masimo INVSENSOR00073 sensor. Masimo INVSENSOR00073: Noninvasive blood pressure monitor
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	25 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	5 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	6 Participants n=5 Participants
Region of Enrollment United States	25 participants n=5 Participants

Timeframe: 1-5 hours.

Population: 9 subjects not analyzed due to incorrect software version

Accuracy and precision of mean arterial pressure (MAP) measured by Masimo INVSENSOR00073 in comparison to radial arterial line.

Outcome measures
Measure	Masimo INVSENSOR00073 n=16 Participants All subjects who are enrolled into the test group and participate in data collection receive the noninvasive Masimo INVSENSOR00073 sensor. Masimo INVSENSOR00073: Noninvasive blood pressure monitor
Mean Arterial Pressure (MAP) Accuracy and Precision of Masimo INVSENSOR00073	1.38 Millimeters of mercury (mmHg) Standard Deviation 4.98

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	Masimo INVSENSOR00073 n=101 participants at risk All subjects who are enrolled into the test group and participate in data collection receive the noninvasive Masimo INVSENSOR00073 sensor. Masimo INVSENSOR00073: Noninvasive blood pressure monitor
Injury, poisoning and procedural complications Venous sample complications	4.0% 4/101 • 1-5 hours
Injury, poisoning and procedural complications Arterial line complications	2.0% 2/101 • 1-5 hours
Injury, poisoning and procedural complications Infusion effects	4.0% 4/101 • 1-5 hours

Masimo Corporation

Phone: 949-297-7000