Comparison of Non-Invasive Blood Pressure Methods

NCT04296227 | Completed Results DMC FDA Device

• 1 other identifier: PR2019-329
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

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.

Conditions

Blood Pressure

Keywords

Blood pressure, Non-Invasive

Outcome Measures

Primary Outcomes (1)

• Validate Non-invasive Blood Pressure Measurement Accuracy for the Vital Detect Blood Pressure Monitor.

  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

  1 Hour

Study Arms (1)

ISO 81060-2:2018.

EXPERIMENTAL

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

Interventions

The Vital Detect blood pressure monitor DEVICE

The end goal is to provide Non-invasive Blood Pressure (NIBP) accuracy data to support validation of the Vital Detect blood pressure monitor.

ISO 81060-2:2018.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vital USA, Inc.: lead
• Clinimark, LLC: collaborator

Study Sites (1)

Clinimark Laboratory Services

Louisville, Colorado, 80027, United States

Location

Related Publications (4)

• 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. doi: 10.1097/00000542-199007000-00030. No abstract available.

  PMID: 2360731 BACKGROUND

• Tollner 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. doi: 10.1016/s0022-3476(80)80582-8. No abstract available.

  PMID: 7365605 BACKGROUND

• 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. doi: 10.1007/BF00858363.

  PMID: 3585434 BACKGROUND

• Bause GS, Weintraub AC, Tanner GE. Skin avulsion during oscillometry. J Clin Monit. 1986 Oct;2(4):262-3. doi: 10.1007/BF02851174.

  PMID: 3783197 RESULT

Limitations and 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.

Results Point of Contact

• Title: Mark H Khachaturian, PhD
• Organization: Vital USA Inc.

mark.khachaturian@vvvital.com

+1(561)282-6074

Study Officials

• Paul Batchelder

  Clinimark Laboratory Services

  PRINCIPAL INVESTIGATOR

• Dena M Raley

  Clinimark Laboratory Services

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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 hour

Study Record Dates

• First Submitted: February 21, 2020
• First Posted: March 5, 2020
• Study Start: February 4, 2020
• Primary Completion: March 3, 2020
• Study Completion: March 3, 2020
• Last Updated: May 13, 2020
• Results First Posted: May 5, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)