Blood PressureNIBPNCT04296227

Comparison of Non-Invasive Blood Pressure Methods

A study testing The Vital Detect blood pressure monitor in people with Blood Pressure, run by Vital USA, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

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. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Blood Pressure
What is being tested?: The Vital Detect blood pressure monitor
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 85 participants
Where: 1 siteUnited States
Study dates: 4 Feb 2020to 3 Mar 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Clinimark Laboratory Services
Louisville, Colorado, 80027

Other trials in United States

About this study

Official title: Multiparameter Monitor Non-Invasive Blood Pressure Validation Study

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.

Read the 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).

Conditions: Blood Pressure
Being tested: The Vital Detect blood pressure monitor
Keywords: Blood pressure, Non-Invasive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT04296227
Study group	Role	What they receive
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. Receives: Device: The Vital Detect blood pressure monitor

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 1 Hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Feb 20203 Mar 2020

First posted5 Mar 2020
Study start4 Feb 2020
Primary completion3 Mar 2020
Study completion3 Mar 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Blood PressureStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
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
Masking: None (open label)
Enrolment: 85 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04296227
Sponsor's protocol ID: PR2019-329
Acronym: NIBP
Status last verified: May 2020
First submitted: 21 Feb 2020
Last updated: 13 May 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

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. doi: 10.1097/00000542-199007000-00030. No abstract available.
PubMed 2360731
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.
PubMed 7365605
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.
PubMed 3585434
Bause GS, Weintraub AC, Tanner GE. Skin avulsion during oscillometry. J Clin Monit. 1986 Oct;2(4):262-3. doi: 10.1007/BF02851174.
PubMed 3783197

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
RecruitingPhase 3
A Phase III Renal Outcomes and Cardiovascular Mortality Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin in Participants With Chronic Kidney Disease and High Blood Pressure
Chronic Kidney Disease and Hypertension
Recruiting
Guiding Optimal Blood Pressure Management in Peritoneal Dialysis Pilot Trial
End Stage Kidney Disease (ESKD), Hypertension (HTN)
RecruitingPhase 4
Hematological Safety of Dipyrone Versus Paracetamol After Dental Extractions
Hematologic Test, Agranulocytosis
Not yet recruiting
Acute Effects of Mat Pilates on Blood Pressure Response to Mental Stress in Higher Education Teachers
Behavior

All Blood Pressure trials

Study at a glance

From the registry record, last updated by the sponsor on 13 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Multiparameter Monitor Non-Invasive Blood Pressure Validation Study
ClinicalTrials.gov ID: NCT04296227
Acronym / sponsor ID: NIBP / PR2019-329
Conditions: Blood Pressure
Keywords: Blood pressure, Non-Invasive
Study type: Interventional
Recruitment status: Completed
Enrolment: 85 participants (actual)
Lead sponsor: Vital USA, Inc.Industry (pharma, biotech, devices)
Collaborators: Clinimark, LLC
Study start: 4 Feb 2020 (actual)
Primary completion: 3 Mar 2020 (actual)
Study completion: 3 Mar 2020 (actual)
First posted: 5 Mar 2020 (actual)
Results: Posted 5 May 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
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

Arm	Type	Receives
ISO 81060-2:2018.	Experimental	Device: The Vital Detect blood pressure monitorThe 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (8 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
The Vital Detect blood pressure monitorThe end goal is to provide Non-invasive Blood Pressure (NIBP) accuracy data to support validation of the Vital Detect blood pressure monitor.	Device	ISO 81060-2:2018.

Primary outcome

Validate Non-invasive Blood Pressure Measurement Accuracy for the Vital Detect Blood Pressure Monitor.
Time frame: 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

Results and safety

Results posted to the registry on 5 May 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ISO 81060-2:2018.	85	85

Primary outcome: Validate Non-invasive Blood Pressure Measurement Accuracy for the Vital Detect Blood Pressure Monitor.

Time frame: 1 Hour. Mean (Standard Deviation). Unit: mmHg

Measure	ISO 81060-2:2018. n = 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)

Population analysed: 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

Adverse events

Time frame: up to 15 days.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ISO 81060-2:2018.	0 of 85 (0%)	0 of 85 (0%)	0 of 85

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 2360731Bickler 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.
Background: PubMed 7365605Tollner 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.
Background: PubMed 3585434Celoria 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.
Results publication: PubMed 3783197Bause GS, Weintraub AC, Tanner GE. Skin avulsion during oscillometry. J Clin Monit. 1986 Oct;2(4):262-3. doi: 10.1007/BF02851174.
Individual participant dataSharing planned: No

Related trials for Blood Pressure

Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
RecruitingPhase 3
A Phase III Renal Outcomes and Cardiovascular Mortality Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin in Participants With Chronic Kidney Disease and High Blood Pressure
Chronic Kidney Disease and Hypertension
Recruiting
Guiding Optimal Blood Pressure Management in Peritoneal Dialysis Pilot Trial
End Stage Kidney Disease (ESKD), Hypertension (HTN)
RecruitingPhase 4
Hematological Safety of Dipyrone Versus Paracetamol After Dental Extractions
Hematologic Test, Agranulocytosis
Not yet recruiting
Acute Effects of Mat Pilates on Blood Pressure Response to Mental Stress in Higher Education Teachers
Behavior

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Paul Batchelder principal investigator

Clinimark Laboratory Services

Dena M Raley study director

Clinimark Laboratory Services

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing The Vital Detect blood pressure monitor in people with Blood Pressure, run by Vital USA, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 May 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Validate Non-invasive Blood Pressure Measurement Accuracy for the Vital Detect Blood Pressure Monitor. (time frame: 1 Hour). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04296227, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2020.