Blood PressureNCT07684859
NIBP Accuracy Study for Adult
An observational study of Blood Pressure and Blood Pressure Measurement, run by GE Healthcare at 1 site in Finland.
Trial summary
The purpose of this study is developing new NIBP enhancement. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blood Pressure, Blood Pressure Measurement
- How many people
- 0 participants
- Where
- 1 siteFinland
- Study dates
- 14 Jan 2025to 31 Dec 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient treated in Meilahti Hospital Cath Lab
Who may be able to join
- Age requirement: 18 and over.
- Have an upper limb (right OR left side) that fits the cuff size of the device (circumference ranging 17 cm to 40 cm) OR have a thigh (right OR left side) that fits a cuff size of the device (circumference ranging 38 to 50 cm).
- Have an arterial line as a standard of care, which measures blood pressure at the aortic root.
- Able to provide written informed consent.
- Expected to remain in the unit for the duration of the study procedure.
Who cannot join
- Have previously participated in this study (no subject may participate more than once).
- Pregnant and lactating women per site standard of care.
- Subjects with peripheral arterial diseases (causing left/right arm difference).
- Subjects with complications, who is on vasoactive agents at discretion of the PI.
- Exhibited injuries, deformities, intravenous lines, or other abnormalities that, in the opinion of the Investigator, may prevent proper cuff application or functioning.
- Are suffering from infection(s) or immunocompromised patients that require isolation.
- PI or designee decision due to subject health conditions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non-Invasive Blood Pressure Accuracy Study for Adult Subject Populations
The purpose of this study is developing new NIBP enhancement.
Read the detailed description
The measurement of blood pressure is an important physiological parameter in cardiovascular health. The accurate and continuous monitoring of blood pressure assures optimal care in various clinical settings. Blood pressure can be measured both by invasive and non-invasive methods. Measurement of blood pressure via arterial cannulation is the direct invasive clinical reference method. However, because invasive blood pressure measurement requires trained clinicians and involves potential complications, non-invasive blood pressure measurement is preferred. Non-invasive method uses non-invasive sphygmomanometers.
Non-invasive blood pressure measurement is based on the estimation of blood pressure. Because the accuracy in blood pressure measurement is essential to monitor patients, the reliability of non-invasive sphygmomanometers is required by internationally recognized standards. Safety and performance of automated sphygmomanometers are complied with IEC 80601-2-30:2018 and ISO 81060-2:2018: AMD2 (approved).
- Conditions
- Blood Pressure, Blood Pressure Measurement
What is being measured
The primary outcome is the main question the study is designed to answer.
Collection of Non-Invasive Blood Pressures and Invasive Blood Pressures
The primary outcome will be the collection of blood non-invasive blood pressure measurements and invasive blood pressure measurements from adult, using NIBP Standard Parameter enhancement per ISO 81060-2 requirements.
Per subject, Non-Invasive Blood Pressure and Invasive Blood Pressure endpoints are collected for:
Systolic BP (mmHg) Diastolic BP (mmHg) NIBP and IBP Mean Arterial Blood Pressure (MAP)
Measured: From admission to discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start14 Jan 2025
- Primary completion30 Sep 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Why it stopped: duplicate record
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- More trials run by GE HealthcareThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- GE Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07684859
- Sponsor's protocol ID
- 226421268
- Status last verified
- Mar 2025
- First submitted
- 31 Mar 2025
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Invasive Blood Pressure Accuracy Study for Adult Subject Populations
- ClinicalTrials.gov ID
- NCT07684859
- Acronym / sponsor ID
- 226421268
- Conditions
- Blood Pressure, Blood Pressure Measurement
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: duplicate record
- Enrolment
- 0 participants (actual)
- Lead sponsor
- GE HealthcareIndustry (pharma, biotech, devices)
- Study start
- 14 Jan 2025 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 6 Jul 2026 (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 developing new NIBP enhancement.
Detailed description
The measurement of blood pressure is an important physiological parameter in cardiovascular health. The accurate and continuous monitoring of blood pressure assures optimal care in various clinical settings. Blood pressure can be measured both by invasive and non-invasive methods. Measurement of blood pressure via arterial cannulation is the direct invasive clinical reference method. However, because invasive blood pressure measurement requires trained clinicians and involves potential complications, non-invasive blood pressure measurement is preferred. Non-invasive method uses non-invasive sphygmomanometers.
Non-invasive blood pressure measurement is based on the estimation of blood pressure. Because the accuracy in blood pressure measurement is essential to monitor patients, the reliability of non-invasive sphygmomanometers is required by internationally recognized standards. Safety and performance of automated sphygmomanometers are complied with IEC 80601-2-30:2018 and ISO 81060-2:2018: AMD2 (approved).
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient treated in Meilahti Hospital Cath Lab
Key inclusion criteria (5 listed)
- Age requirement: 18 and over.
- Have an upper limb (right OR left side) that fits the cuff size of the device (circumference ranging 17 cm to 40 cm) OR have a thigh (right OR left side) that fits a cuff size of the device (circumference ranging 38 to 50 cm).
- Have an arterial line as a standard of care, which measures blood pressure at the aortic root.
- Able to provide written informed consent.
- Expected to remain in the unit for the duration of the study procedure.
Key exclusion criteria (7 listed)
- Have previously participated in this study (no subject may participate more than once).
- Pregnant and lactating women per site standard of care.
- Subjects with peripheral arterial diseases (causing left/right arm difference).
- Subjects with complications, who is on vasoactive agents at discretion of the PI.
- Exhibited injuries, deformities, intravenous lines, or other abnormalities that, in the opinion of the Investigator, may prevent proper cuff application or functioning.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Collection of Non-Invasive Blood Pressures and Invasive Blood Pressures
Time frame: From admission to discharge
The primary outcome will be the collection of blood non-invasive blood pressure measurements and invasive blood pressure measurements from adult, using NIBP Standard Parameter enhancement per ISO 81060-2 requirements. Per subject, Non-Invasive Blood Pressure and Invasive Blood Pressure endpoints are collected for: Systolic BP (mmHg) Diastolic BP (mmHg) NIBP and IBP Mean Arterial Blood Pressure (MAP)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Individual participant dataSharing planned: No
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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 Blood Pressure and Blood Pressure Measurement, run by GE Healthcare at 1 site in Finland.
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 5 inclusion and 7 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: withdrawn, as of the sponsor's last update on 6 Jul 2026. 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 Finland. 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 withdrawn before enrolling participants, so there are no results.
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?
Collection of Non-Invasive Blood Pressures and Invasive Blood Pressures (time frame: From admission to discharge). 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 6 Jul 2026.