Non Invasive Blood PressureNCT06682312
Philips Non-Invasive Blood Pressure Validation Study
An observational study of Non Invasive Blood Pressure, run by Philips Clinical & Medical Affairs Global at 1 site in United States.
Trial summary
The purpose of this study is to provide supporting documentation of the blood pressure performance for the Philips EarlyVue VS30 monitor on the intended adult and pediatric population. The same arm sequential method with dual observer auscultation will be used to collect data. Read more about this study
- Who is it for?
- Ages 3 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Non Invasive Blood Pressure
- What is being tested?
- Non-invasive blood pressure
- Type of treatment
- Medical device
- How many people
- 89 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Oct 2024to 23 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 3 to 85 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Healthy volunteers, both male and females aged 3-85. Minimum of 35 participants aged 3-12 and a minimum of 50 participants aged >12-85
Who may be able to join
- Participants must be able to provide an informed consent or have legally authorized representative consent to participate.
- Participants that are between 7 and 17 years of age must provide assent to participate in the study.
- Participant must be willing and able to comply with the study procedures.
- Participant or legally authorized representative must be able to read or write in English.
- Participant must be 3 to 85 years of age.
- Participants must have an arm circumference in the range of 14-45 centimeters.
Who cannot join
- Participant is unwilling to provide informed consent.
- Participants with deformities or abnormalities that may prevent proper application of the device under test.
- Participants whose upper arm circumference is less than 14 cm or greater than 45 cm.
- Female participants who are self-reported as pregnant, or who are self-reported as trying to get pregnant.
- Participants with known heart arrhythmias.
- Participants with peripheral vascular disease.
Show all 14Show fewer
- Participants with clotting disorders.
- History of bleeding disorders or personal history of prolonged bleeding from injury
- History of blood clots
- Hemophilia
- Participants that cannot tolerate sitting for up to 1 hour.
- Participant with a blood pressure demographic that has already been filled.
- Other known health conditions that will prevent safe participation in the study upon disclosure in health assessment form or verbally.
- Participant is evaluated by the investigator or clinician and found to be medically unsuitable for participation in this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Element Materials Technology
Louisville, Colorado, 80027
About this study
Official title: Element Boulder Clinical Investigation Plan Philips Non-Invasive Blood Pressure Validation Study
The purpose of this study is to provide supporting documentation of the blood pressure performance for the Philips EarlyVue VS30 monitor on the intended adult and pediatric population. The same arm sequential method with dual observer auscultation will be used to collect data.
Read the detailed description
The Philips EarlyVue VS30 monitor, and approved Philips Gentle Care cuffs will be evaluated in comparison to dual reference auscultation. The study will consist of a minimum of 85 participants, specifically, 35 children aged 3-12 years and 50 participants older than 12 years. The participants enrolled will approximate the distribution of blood pressures and biceps circumferences as outlined in ISO 81060-2:2018/AMD 2:2024. The maximum number of participants enrolled will not exceed 170 participants.
Blood pressure measurements will follow ISO 81060-2:2018/AMD 2:2024, Section 5.2.4.1 Same arm sequential method.
Two trained observers, typically a Registered Nurse (RN), Licensed Practical Nurse (LPN), or Respiratory Therapist (RT) will observe (listen to) the Korotkoff sounds at the artery at the site of cuff placement. The reference blood pressure measurements observed by the auscultators will be performed sequentially with the device under test. The auscultators will complete 1 or 2 initial baseline auscultatory reference blood pressure measurements and device under test measurements. This is followed by 3 to 8 paired blood pressure readings of auscultatory reference blood pressure measurements alternated with device under test measurements. All participants must contribute 3 valid paired data points requiring three DUT readings paired with three reference blood pressure readings. The reference blood pressure readings for analysis will be the average of the reference dual auscultation values before and after DUT reading.
The data included for the final analysis will contain no fewer than 35 participants aged 3-12 years, and no fewer than 50 participants over the age of 12 and a minimum of 255 valid paired observations.
- Conditions
- Non Invasive Blood Pressure
- Being tested
- Non-invasive blood pressure
- Keywords
- NIBP, Blood pressure, Spotcheck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive blood pressureDevice
Manual blood pressure via sphygmomanometer
Or
Non invasive blood pressure via earlyvue VS30 Monitor
| Study group | Role | What they receive |
|---|---|---|
| Pediatrics | Participants aged 3-12 years Receives: Device: Non-invasive blood pressure | |
| Adults | Participants aged 12-85 years |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation of earlyvue VS30 Monitor
The primary objective of this study is to provide a validation following ISO 81060-2:2018/AMD 2:2024 for noninvasive blood pressure measurement accuracy for the Philips EarlyVue VS30 on the intended population. The EarlyVue VS30 will be compared to the reference sphygmomanometer via same arm sequential method with dual auscultators.
The end goal is to pass the Criterion 1 and Criterion 2 of ISO 81060-2:2018/AMD 2:2024 Criterion 1
- Mean Error of individual paired determinations ≤ ±5.0 mmHg
- Standard Deviation of determination ≤ 8.0mmHg
Criterion 2
- Standard Deviation of the average paired determinations must meet the maximum permissible standard deviation in Table 1 - Averaged subject data acceptance (criterion 2) in mmHg per the standard
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start14 Oct 2024
- Primary completion23 Oct 2024
- Study completion23 Oct 2024
Why it stopped: Protocol violations resulting in wrong stratification requirements
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Invasive Blood PressureStudies of the same condition, open and under way.
- More trials run by Philips Clinical & Medical Affairs GlobalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philips Clinical & Medical Affairs Global
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Element Materials Technology
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06682312
- Sponsor's protocol ID
- PR 2024-601
- Status last verified
- Nov 2024
- First submitted
- 7 Nov 2024
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Study has been terminated and no analysis will be done
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Element Boulder Clinical Investigation Plan Philips Non-Invasive Blood Pressure Validation Study
- ClinicalTrials.gov ID
- NCT06682312
- Acronym / sponsor ID
- PR 2024-601
- Conditions
- Non Invasive Blood Pressure
- Keywords
- NIBP, Blood pressure, Spotcheck
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Protocol violations resulting in wrong stratification requirements
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Philips Clinical & Medical Affairs GlobalIndustry (pharma, biotech, devices)
- Collaborators
- Element Materials Technology
- Study start
- 14 Oct 2024 (actual)
- Primary completion
- 23 Oct 2024 (actual)
- Study completion
- 23 Oct 2024 (actual)
- First posted
- 12 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to provide supporting documentation of the blood pressure performance for the Philips EarlyVue VS30 monitor on the intended adult and pediatric population. The same arm sequential method with dual observer auscultation will be used to collect data.
Detailed description
The Philips EarlyVue VS30 monitor, and approved Philips Gentle Care cuffs will be evaluated in comparison to dual reference auscultation. The study will consist of a minimum of 85 participants, specifically, 35 children aged 3-12 years and 50 participants older than 12 years. The participants enrolled will approximate the distribution of blood pressures and biceps circumferences as outlined in ISO 81060-2:2018/AMD 2:2024. The maximum number of participants enrolled will not exceed 170 participants.
Blood pressure measurements will follow ISO 81060-2:2018/AMD 2:2024, Section 5.2.4.1 Same arm sequential method.
Two trained observers, typically a Registered Nurse (RN), Licensed Practical Nurse (LPN), or Respiratory Therapist (RT) will observe (listen to) the Korotkoff sounds at the artery at the site of cuff placement. The reference blood pressure measurements observed by the auscultators will be performed sequentially with the device under test. The auscultators will complete 1 or 2 initial baseline auscultatory reference blood pressure measurements and device under test measurements. This is followed by 3 to 8 paired blood pressure readings of auscultatory reference blood pressure measurements alternated with device under test measurements. All participants must contribute 3 valid paired data points requiring three DUT readings paired with three reference blood pressure readings. The reference blood pressure readings for analysis will be the average of the reference dual auscultation values before and after DUT reading.
The data included for the final analysis will contain no fewer than 35 participants aged 3-12 years, and no fewer than 50 participants over the age of 12 and a minimum of 255 valid paired observations.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pediatrics | – | Device: Non-invasive blood pressureParticipants aged 3-12 years |
| Adults | – | –Participants aged 12-85 years |
Who may qualify
- Ages
- 3 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Healthy volunteers, both male and females aged 3-85. Minimum of 35 participants aged 3-12 and a minimum of 50 participants aged >12-85
Key inclusion criteria (6 listed)
- Participants must be able to provide an informed consent or have legally authorized representative consent to participate.
- Participants that are between 7 and 17 years of age must provide assent to participate in the study.
- Participant must be willing and able to comply with the study procedures.
- Participant or legally authorized representative must be able to read or write in English.
- Participant must be 3 to 85 years of age.
Key exclusion criteria (14 listed)
- Participant is unwilling to provide informed consent.
- Participants with deformities or abnormalities that may prevent proper application of the device under test.
- Participants whose upper arm circumference is less than 14 cm or greater than 45 cm.
- Female participants who are self-reported as pregnant, or who are self-reported as trying to get pregnant.
- Participants with known heart arrhythmias.
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 |
|---|---|---|
| Non-invasive blood pressureManual blood pressure via sphygmomanometer Or Non invasive blood pressure via earlyvue VS30 Monitor | Device | Pediatrics |
Primary outcome
Validation of earlyvue VS30 Monitor
Time frame: 2 weeks
The primary objective of this study is to provide a validation following ISO 81060-2:2018/AMD 2:2024 for noninvasive blood pressure measurement accuracy for the Philips EarlyVue VS30 on the intended population. The EarlyVue VS30 will be compared to the reference sphygmomanometer via same arm sequential method with dual auscultators. The end goal is to pass the Criterion 1 and Criterion 2 of ISO 81060-2:2018/AMD 2:2024 Criterion 1 * Mean Error of individual paired determinations ≤ ±5.0 mmHg * Standard Deviation of determination ≤ 8.0mmHg Criterion 2 • Standard Deviation of the average paired determinations must meet the maximum permissible standard deviation in Table 1 - Averaged subject data acceptance (criterion 2) in mmHg per the standard
Results and safety
The study was stopped early (reason given: Protocol violations resulting in wrong stratification requirements). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
- Individual participant dataSharing planned: No. Study has been terminated and no analysis will be done
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non Invasive Blood Pressure, run by Philips Clinical & Medical Affairs Global 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 14 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: stopped early, as of the sponsor's last update on 12 Nov 2024. 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?
The study was stopped early (reason given: Protocol violations resulting in wrong stratification requirements). Results are not available in the source record.
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?
Validation of earlyvue VS30 Monitor (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Nov 2024.