NIBP: Comparison of Non-Invasive Blood Pressure Methods

• Sponsor: Vital USA, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04296227
• Collaborator: Clinimark, LLC (Other)
• Enrollment: 85
• Location: 1
• Arm: 1
• Actual Duration (Days): 28
• Patients Per Site Per Month: 92.4

Study Details

Study Description

Brief Summary

The primary objective of the study is to demonstrate the accuracy in healthy adults with Vital USA Device by comparison to a non-invasive (auscultatory) reference sphygmomanometer.

The procedure, data collection methods and data analysis that are outlined in the protocol follow the standard: International Standards Organization (ISO) 81060-2:2018 Non-invasive Sphygmomanometers - Part 2: Clinical validation of automated measurement type.

Condition or Disease	Intervention/Treatment	Phase
Blood Pressure	Device: The Vital Detect blood pressure monitor	N/A

Detailed Description

This study will include up to 100 adults ≥ 18 years of age. The final subject database will contain no fewer than 85 subjects with a minimum of 255 paired observations. At least 90% of the subjects will contribute 3 paired observations, if necessary the balance of the data will be added from additional subjects.

An interim analysis will be conducted at the end of Part 1 data collection and will consist of simple statistics that will compare the test device tot he reference cuff non-invasive (auscultatory) reference sphygmomanometer.

Part 2 data collection will be conducted after Part 1 data collection interim report is reviewed and additional data collection is approved by the client. It will test an additional 55 subjects (plus extra subjects as replacements if necessary).

Study Design

• Study Type: Interventional
• Actual Enrollment: 85 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: The Vital Detect blood pressure monitor will be evaluated as a comparative, single center, non-randomized, study in a minimum of 30 subjects, conducted in 2 phases. The maximum number of subjects enrolled is 150 for both phases, to achieve 85 valid data sets. Each subject test is expected to take up to 1 hourThe Vital Detect blood pressure monitor will be evaluated as a comparative, single center, non-randomized, study in a minimum of 30 subjects, conducted in 2 phases. The maximum number of subjects enrolled is 150 for both phases, to achieve 85 valid data sets. Each subject test is expected to take up to 1 hour
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Multiparameter Monitor Non-Invasive Blood Pressure Validation Study
• Actual Study Start Date: Feb 4, 2020
• Actual Primary Completion Date: Mar 3, 2020
• Actual Study Completion Date: Mar 3, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Device: 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.

Outcome Measures

Primary Outcome Measures

1. Validate Non-invasive Blood Pressure Measurement Accuracy for the Vital Detect Blood Pressure Monitor. [1 Hour]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Subjects must be able to provide an informed consent or have legally authorized representative consent to participate.

• Subject must be willing and able to comply with the study procedures.

• Subject must be ≥ 18

• Subject or legally authorized representative must be able to read or write in English.

• Subjects with a finger circumference < 8.3 cm.in the range of 10-25 mm

• At least 30% of subjects shall be male and at least 30% of subjects shall be female

Exclusion Criteria:

• Lack of Informed consent.

• Subjects with deformities or abnormalities that may prevent proper application of the device under test.

• Subject is evaluated by the investigator or clinician and found to be medically unsuitable for participation in this study.

• Subjects with known heart dysrhythmias

• Subjects with compromised circulation or peripheral vascular disease.

• Subjects with clotting disorders or taking prescribed blood thinners.

• Subjects that cannot tolerate sitting for up to 1 hour.

• Subject with a blood pressure demographic that has already been filled

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinimark Laboratory Services	Louisville	Colorado	United States	80027

Sponsors and Collaborators

• Vital USA, Inc.
• Clinimark, LLC

Investigators

• Principal Investigator: Paul Batchelder, Clinimark Laboratory Services
• Study Director: Dena M Raley, Clinimark Laboratory Services

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Apr 17, 2019

More Information

Publications

• Bickler PE, Schapera A, Bainton CR. Acute radial nerve injury from use of an automatic blood pressure monitor. Anesthesiology. 1990 Jul;73(1):186-8.
• Celoria G, Dawson JA, Teres D. Compartment syndrome in a patient monitored with an automated blood pressure cuff. J Clin Monit. 1987 Apr;3(2):139-41.
• Töllner U, Bechinger D, Pohlandt F. Radial nerve palsy in a premature infant following long-term measurement of blood pressure. J Pediatr. 1980 May;96(5):921-2.

• Responsible Party: Vital USA, Inc.
• ClinicalTrials.gov Identifier: NCT04296227
• Other Study ID Numbers: PR2019-329
• First Posted: Mar 5, 2020
• Last Update Posted: May 13, 2020
• Last Verified: May 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Vital USA, Inc.: Blood pressure, Non-Invasive

Study Results

Participant Flow

Recruitment Details	The final study population consisted of 85 qualified healthy subjects ranging from 18 to 81 years of age of any racial / ethnic background.
Pre-assignment Detail	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.

Arm/Group Title	ISO 81060-2:2018.
Arm/Group Description	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.
Period Title: Overall Study
STARTED	85
COMPLETED	85
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	ISO 81060-2:2018.
Arm/Group Description	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 Participants	85
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	85 100%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	51 60%
Male	34 40%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (Count of Participants)
United States	85 100%
Noninvasive Blood Pressure Measurement (participants) [Number]
Number [participants]	85 100%

Outcome Measures

1. Primary Outcome

Title	Validate Non-invasive Blood Pressure Measurement Accuracy for the Vital Detect Blood Pressure Monitor.
Description	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
Time Frame	1 Hour

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	ISO 81060-2:2018.
Arm/Group Description	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.
Measure Participants	85
Systolic Pressure C1	4.40 (10.97)
Systolic Pressure C2	4.40 (9.24)
Diastolic Pressure C1	3.26 (7.21)
Diastolic Pressure C2	3.26 (6.72)

Adverse Events

Time Frame	up to 15 days.
Arm/Group Title	ISO 81060-2:2018.
Arm/Group Description	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.
All Cause Mortality
	ISO 81060-2:2018.
	Affected / at Risk (%)	# Events
Total	0/85 (0%)
Serious Adverse Events
	ISO 81060-2:2018.
	Affected / at Risk (%)	# Events
Total	0/85 (0%)
Other (Not Including Serious) Adverse Events
	ISO 81060-2:2018.
	Affected / at Risk (%)	# Events
Total	0/85 (0%)

Limitations/Caveats

Two types of device deficiencies. First was the device would go through its measurement process as expected but did not provide a reading at end of deflation.Second involved connectivity issues between the Vital Detect and the Vital USA app.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.