Trial Outcomes & Findings for Validation of Noninvasive Blood Pressure Device (NCT NCT04676152)

Last Updated: 2024-01-08

Results Overview

Performance will be determined by calculating the mean and standard deviation of the differences between the systolic and diastolic blood pressure measurements obtained from Masimo NIBP device and manual sphygmomanometer.

Recruitment status

COMPLETED

Study phase

Target enrollment

106 participants

Primary outcome timeframe

1 hour

Results posted on

2024-01-08

Participant Flow

Participant milestones

Participant milestones
Measure	Test Subjects Masimo Noninvasive Blood Pressure Device: All enrolled subjects will have blood pressure measurements done using the Masimo NIBP device and the noninvasive blood pressure device
Overall Study STARTED	106
Overall Study COMPLETED	97
Overall Study NOT COMPLETED	9

Reasons for withdrawal

Reasons for withdrawal
Measure	Test Subjects Masimo Noninvasive Blood Pressure Device: All enrolled subjects will have blood pressure measurements done using the Masimo NIBP device and the noninvasive blood pressure device
Overall Study screen fail	9

Baseline Characteristics

Validation of Noninvasive Blood Pressure Device

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Test Subjects n=106 Participants Masimo Noninvasive Blood Pressure Device: All enrolled subjects will have blood pressure measurements done using the Masimo NIBP device and the noninvasive blood pressure device
Age, Customized Age · <=18 years	0 Participants n=5 Participants
Age, Customized Age · Between 18 and 65	88 Participants n=5 Participants
Age, Customized Age · >65 years	15 Participants n=5 Participants
Age, Customized Age · Unknown/Not reported	3 Participants n=5 Participants
Sex/Gender, Customized Gender · Female	59 Participants n=5 Participants
Sex/Gender, Customized Gender · Male	44 Participants n=5 Participants
Sex/Gender, Customized Gender · Unknown/Not Reported	3 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity (NIH/OMB) · American Indian or Alaska Native	0 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity (NIH/OMB) · Asian	26 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity (NIH/OMB) · Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity (NIH/OMB) · Black or African American	2 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity (NIH/OMB) · White	48 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity (NIH/OMB) · Hispanic or Latino	26 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity (NIH/OMB) · More than one race	0 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity (NIH/OMB) · Other	1 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity (NIH/OMB) · Unkown or Not Reported	3 Participants n=5 Participants
Region of Enrollment United States	106 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 hour

Population: Subjects excluded from analysis were as follows: * 9 Subjects were screen fails * 8 Subjects excluded during data analysis

Outcome measures

Outcome measures
Measure	Test Subjects n=89 Participants Masimo Noninvasive Blood Pressure Device: All enrolled subjects will have blood pressure measurements done using the Masimo NIBP device and the noninvasive blood pressure device
Mean and Standard Deviation of Differences Between Masimo NIBP Device and Manual Sphygmomanometer Measurements. Systolic Blood Pressure	-1.23 mmHg Standard Deviation 7.32
Mean and Standard Deviation of Differences Between Masimo NIBP Device and Manual Sphygmomanometer Measurements. Diastolic Blood Pressure	-2.67 mmHg Standard Deviation 7.13

Adverse Events

Test Subjects

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

Chelsea Frank

Masimo Corporation

Phone: 949-297-7000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60