Clinical trial NCT04296227: Comparison of Non-Invasive Blood Pressure Methods
Official title: Multiparameter Monitor Non-Invasive Blood Pressure Validation Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Pressure
Keywords: Blood pressure, Non-Invasive
Lead sponsor: Vital USA, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Clinimark, LLC
First posted: 2020-03-05
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
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 hour
Primary purpose: SUPPORTIVE_CARE

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.

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).

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

Primary outcomes:
measure: Validate Non-invasive Blood Pressure Measurement Accuracy for the Vital Detect Blood Pressure Monitor.
timeFrame: 1 Hour
Secondary outcomes:
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Clinimark Laboratory Services
state: Colorado
Study officials:
affiliation: Clinimark Laboratory Services
name: Paul Batchelder
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinimark Laboratory Services
name: Dena M Raley
role: STUDY_DIRECTOR
References:
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. doi: 10.1097/00000542-199007000-00030. No abstract available.
citation: 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.
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. doi: 10.1007/BF00858363.
citation: Bause GS, Weintraub AC, Tanner GE. Skin avulsion during oscillometry. J Clin Monit. 1986 Oct;2(4):262-3. doi: 10.1007/BF02851174.