N/A
N=85
Comparison of Non-Invasive Blood Pressure Methods
Blood Pressure
Bottom Line
View on ClinicalTrials.gov: NCT04296227 ↗Enrolled (actual)
85
Serious AEs
0.0%
Results posted
May 2020
Primary outcome: Primary: Validate Non-invasive Blood Pressure Measurement Accuracy for the Vital Detect Blood Pressure Monitor. — 4.40; 4.40; 3.26; 3.26 mmHg
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- The Vital Detect blood pressure monitor (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Vital USA, Inc.
- Primary completion
- Mar 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Validate Non-invasive Blood Pressure Measurement Accuracy for the Vital Detect Blood Pressure Monitor. |
4.40; 4.40; 3.26; 3.26 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04296227). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.