Comparison of Non-Invasive Blood Pressure Methods

Blood Pressure Clinical Trial

— NIBP  

Official title:

Multiparameter Monitor Non-Invasive Blood Pressure Validation Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04296227
• Other study ID #: PR2019-329
• Status: Completed
• Phase: N/A
• Start date: February 4, 2020
• Est. completion date: March 3, 2020

Study information

• Verified date: May 2020
• Source: Vital USA, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: March 3, 2020
• Est. primary completion date: March 3, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blood Pressure

Intervention

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.

Locations

Country	Name	City	State
United States	Clinimark Laboratory Services	Louisville	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
Vital USA, Inc.	Clinimark, LLC

Country where clinical trial is conducted

United States, 

References & Publications (4)

Bause GS, Weintraub AC, Tanner GE. Skin avulsion during oscillometry. J Clin Monit. 1986 Oct;2(4):262-3. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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) Criterion 2: Standard Deviation (Systolic) (Diastolic)	1 Hour