Trial Outcomes & Findings for Comparison of Non-Invasive Blood Pressure Methods (NCT NCT04296227)

Results Overview

The primary objective of this study is to provide a validation for non-invasive blood pressure measurement accuracy for the Vital Detect blood pressure monitor when compared to the Reference Sphygmomanometer. Data taken was based on dual observers (Criterion 1(C1), Criterion 2 (C2) for both Systolic and Diastolic determinations. Since the same arm sequential method was used, data for a given subject were averaged to create the reference blood pressure determination against the acceptance criteria. The device under test (DUT) passed or failed the determination based on the mean error and standard deviation of the determination. The acceptance criteria: Criterion 1: Mean Error Standard Deviation (Systolic / Diastolic) (Systolic / Diastolic) \</= 5.0 mmHg \</= 8.0 mmHg Criterion 2: Standard Deviation (Systolic) (Diastolic) \</= 5.33 mmHg \</= 6.09 mmHg

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

85 participants

Primary outcome timeframe

1 Hour

Results posted on

2020-05-13

Participant Flow

The final study population consisted of 85 qualified healthy subjects ranging from 18 to 81 years of age of any racial / ethnic background.

The subjects understood the study and provided consent for participation by signing the Independent Review Board (IRB) approved Informed Consent Form prior to start of the test. The subjects were informed about the clinical investigation within his/her ability to understand following the established informed consent process.

Participant milestones

Participant milestones
Measure	ISO 81060-2:2018. The intended purpose of the test is to evaluate the Vital Detect blood pressure monitor to ISO 81060-2:2018. The intended use for these products are manual and automatic Non-Invasive Blood Pressure monitoring on adults age 18 and older. The Vital Detect blood pressure monitor: The end goal is to provide Non-invasive Blood Pressure (NIBP) accuracy data to support validation of the Vital Detect blood pressure monitor.
Overall Study STARTED	85
Overall Study COMPLETED	85
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ISO 81060-2:2018. n=85 Participants The intended purpose of the test is to evaluate the Vital Detect blood pressure monitor to ISO 81060-2:2018. The intended use for these products are manual and automatic Non-Invasive Blood Pressure monitoring on adults age 18 and older. The Vital Detect blood pressure monitor: The end goal is to provide Non-invasive Blood Pressure (NIBP) accuracy data to support validation of the Vital Detect blood pressure monitor.
Age, Categorical <=18 years	0 Participants n=85 Participants
Age, Categorical Between 18 and 65 years	85 Participants n=85 Participants
Age, Categorical >=65 years	0 Participants n=85 Participants
Sex: Female, Male Female	51 Participants n=85 Participants
Sex: Female, Male Male	34 Participants n=85 Participants
Region of Enrollment United States	85 Participants n=85 Participants
Noninvasive Blood Pressure Measurement	85 participants n=85 Participants

PRIMARY outcome

Timeframe: 1 Hour

Population: The final study population consisted of 85 qualified healthy subjects ranging from 18 to 81 years of age of any racial / ethnic background. The subjects were healthy showing no evidence

The primary objective of this study is to provide a validation for non-invasive blood pressure measurement accuracy for the Vital Detect blood pressure monitor when compared to the Reference Sphygmomanometer. Data taken was based on dual observers (Criterion 1(C1), Criterion 2 (C2) for both Systolic and Diastolic determinations. Since the same arm sequential method was used, data for a given subject were averaged to create the reference blood pressure determination against the acceptance criteria. The device under test (DUT) passed or failed the determination based on the mean error and standard deviation of the determination. The acceptance criteria: Criterion 1: Mean Error Standard Deviation (Systolic / Diastolic) (Systolic / Diastolic) \</= 5.0 mmHg \</= 8.0 mmHg Criterion 2: Standard Deviation (Systolic) (Diastolic) \</= 5.33 mmHg \</= 6.09 mmHg

Outcome measures

Outcome measures
Measure	ISO 81060-2:2018. n=85 Participants The intended purpose of the test is to evaluate the Vital Detect blood pressure monitor to ISO 81060-2:2018. The intended use for these products are manual and automatic Non-Invasive Blood Pressure monitoring on adults age 18 and older. The Vital Detect blood pressure monitor: The end goal is to provide Non-invasive Blood Pressure (NIBP) accuracy data to support validation of the Vital Detect blood pressure monitor.
Validate Non-invasive Blood Pressure Measurement Accuracy for the Vital Detect Blood Pressure Monitor. Systolic Pressure C1	4.40 mmHg Standard Deviation 10.97
Validate Non-invasive Blood Pressure Measurement Accuracy for the Vital Detect Blood Pressure Monitor. Systolic Pressure C2	4.40 mmHg Standard Deviation 9.24
Validate Non-invasive Blood Pressure Measurement Accuracy for the Vital Detect Blood Pressure Monitor. Diastolic Pressure C1	3.26 mmHg Standard Deviation 7.21
Validate Non-invasive Blood Pressure Measurement Accuracy for the Vital Detect Blood Pressure Monitor. Diastolic Pressure C2	3.26 mmHg Standard Deviation 6.72

Adverse Events

ISO 81060-2:2018.

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

Mark H Khachaturian, PhD

Vital USA Inc.

Phone: +1(561)282-6074

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place