Blood PressureNCT05789849
Data Collection for Validation of an NIBP Algorithm in Pregnant Women
A study testing Collecting blood pressure measurements with noninvasive blood pressure device in people with Blood Pressure, run by GE Healthcare at 1 site in United States.
Trial summary
The purpose of the study is to collect per subject blood pressure data on the device's intended population as described in the International Organization for Standardization (ISO) Standard 81060-2:2018+A1:2020 Non-invasive sphygmomanometers. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Blood Pressure
- What is being tested?
- Collecting blood pressure measurements with noninvasive blood pressure device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Sep 2022to Sep 2023
- Phase
- Interventional
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Are pregnant female volunteers aged 18 years or older;
- Gestation beyond the first trimester as evidenced by gestational age of greater than or equal to 14 weeks and 0 days;
- Have compatible anatomy to fit a standard air-filled occlusive cuff size (an upper limb circumference ranging 17 cm to 40 cm);
- Are willing and able to volunteer to provide multiple blood pressure measurements as required for study procedures;
- Are able and willing to provide written informed consent.
Who cannot join
- Exhibit signs or symptoms or have a current diagnosis of peripheral vascular disease;
- Have current, uncontrolled circulatory shock or cardiac arrhythmias that pose risk to the patient or could interfere with completion of study blood pressure determinations;
- Exhibit injuries, deformities, intravenous lines, or other abnormalities that, in the opinion of the investigator, may prevent proper occlusive cuff application or functioning; the investigator, may prevent proper occlusive cuff application or functioning;
- Have contraindications to blood pressure measurement methods used in the study or any medical condition where study procedures could pose a risk to the subject/patient's physiological stability, in the opinion of a medically qualified investigator.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Washington University in St. Louis
St Louis, Missouri, 63110
Tracey Huitt, 314-747-2198, tabell@wustl.edu
About this study
Official title: Data Collection for Validation of a Noninvasive Blood Pressure Auscultatory Algorithm - Pregnant Women
The purpose of the study is to collect per subject blood pressure data on the device's intended population as described in the International Organization for Standardization (ISO) Standard 81060-2:2018+A1:2020 Non-invasive sphygmomanometers.
Read the detailed description
The purpose of the study is to collect data per subject NIBP measurements by (1) oscillometric means using the GE NIBP Auscultatory Algorithm and (2) by conventional auscultatory means in a pregnant population. These measurements include Systolic BP (mmHg) and Diastolic BP (mmHg). The secondary objective of this study is to collect per procedure and log files from the device. The safety objective of this study is to collect safety information, including type and number of adverse events, serious adverse events and device issues.
This is an open label, single-site, single arm, prospective, pivotal study including a training phase and a validation phase with demographics-based stratification quota. Subjects are sequentially tested with investigational and reference blood pressure measurements.
- Conditions
- Blood Pressure
- Being tested
- Collecting blood pressure measurements with noninvasive blood pressure device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collecting blood pressure measurements with noninvasive blood pressure deviceDevice
Also called GE DINAMAP® SuperSTAT algorithm
Noninvasive blood pressure measurements will collected based on the recommendations of the International Organization for Standardization (ISO) 81060-2:2018+A1:2020 Non-invasive sphygmomanometers -Clinical investigation of intermittent automated measurement type. This study has only 1 arm; investigational NIBP measurements will be collected using a NIBP Auscultatory Algorithm with alternating NIBP measurements collected using a reference sphygmomanometer.
| Study group | Role | What they receive |
|---|---|---|
| Blood Pressure Collection | Experimental | This study has only 1 arm; investigational NIBP measurements will be collected using a NIBP Auscultatory Algorithm with alternating NIBP measurements collected using a reference sphygmomanometer. Receives: Device: Collecting blood pressure measurements with noninvasive blood pressure device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Collection of per subject NIBP measurements
The primary objective of this study is to collect per subject NIBP measurements by oscillometric means using the GE NIBP Auscultatory Algorithm and by conventional auscultatory means in a pregnant population. These measurements include both Systolic BP (mmHg) and Diastolic BP (mmHg).
Measured: Start of blood pressure acquisition until three valid pairs obtained, approximately one hour
Secondary outcomes (1)
Collection of per procedure and device log files.
The secondary objective of this study is to collect per procedure and device log files.
Measured: Start of blood pressure acquisition until three valid pairs obtained, approximately one hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2023
- Study start14 Sep 2022
- Primary completionSep 2023 (estimated)
- Study completionSep 2023 (estimated)
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is an open label, single-site, single arm, prospective, pivotal study including a training phase and a data collection phase.
- Masking
- None (open label)
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GE Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nandini Raghuraman, MD, Principal investigator, Division of Maternal-Fetal Medicine Washington University in St Louis School of MedicineAdithya Bhat, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05789849
- Sponsor's protocol ID
- 219397851
- Status last verified
- Mar 2023
- First submitted
- 16 Mar 2023
- Last updated
- 29 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Data Collection for Validation of a Noninvasive Blood Pressure Auscultatory Algorithm - Pregnant Women
- ClinicalTrials.gov ID
- NCT05789849
- Acronym / sponsor ID
- 219397851
- Conditions
- Blood Pressure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- GE HealthcareIndustry (pharma, biotech, devices)
- Study start
- 14 Sep 2022 (actual)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 29 Mar 2023 (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 the study is to collect per subject blood pressure data on the device's intended population as described in the International Organization for Standardization (ISO) Standard 81060-2:2018+A1:2020 Non-invasive sphygmomanometers.
Detailed description
The purpose of the study is to collect data per subject NIBP measurements by (1) oscillometric means using the GE NIBP Auscultatory Algorithm and (2) by conventional auscultatory means in a pregnant population. These measurements include Systolic BP (mmHg) and Diastolic BP (mmHg). The secondary objective of this study is to collect per procedure and log files from the device. The safety objective of this study is to collect safety information, including type and number of adverse events, serious adverse events and device issues.
This is an open label, single-site, single arm, prospective, pivotal study including a training phase and a validation phase with demographics-based stratification quota. Subjects are sequentially tested with investigational and reference blood pressure measurements.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is an open label, single-site, single arm, prospective, pivotal study including a training phase and a data collection phase.
| Arm | Type | Receives |
|---|---|---|
| Blood Pressure Collection | Experimental | Device: Collecting blood pressure measurements with noninvasive blood pressure deviceThis study has only 1 arm; investigational NIBP measurements will be collected using a NIBP Auscultatory Algorithm with alternating NIBP measurements collected using a reference sphygmomanometer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Are pregnant female volunteers aged 18 years or older;
- Gestation beyond the first trimester as evidenced by gestational age of greater than or equal to 14 weeks and 0 days;
- Have compatible anatomy to fit a standard air-filled occlusive cuff size (an upper limb circumference ranging 17 cm to 40 cm);
- Are willing and able to volunteer to provide multiple blood pressure measurements as required for study procedures;
- Are able and willing to provide written informed consent.
Key exclusion criteria (4 listed)
- Exhibit signs or symptoms or have a current diagnosis of peripheral vascular disease;
- Have current, uncontrolled circulatory shock or cardiac arrhythmias that pose risk to the patient or could interfere with completion of study blood pressure determinations;
- Exhibit injuries, deformities, intravenous lines, or other abnormalities that, in the opinion of the investigator, may prevent proper occlusive cuff application or functioning; the investigator, may prevent proper occlusive cuff application or functioning;
- Have contraindications to blood pressure measurement methods used in the study or any medical condition where study procedures could pose a risk to the subject/patient's physiological stability, in the opinion of a medically qualified investigator.
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 |
|---|---|---|
| Collecting blood pressure measurements with noninvasive blood pressure deviceAlso: GE DINAMAP® SuperSTAT algorithmNoninvasive blood pressure measurements will collected based on the recommendations of the International Organization for Standardization (ISO) 81060-2:2018+A1:2020 Non-invasive sphygmomanometers -Clinical investigation of intermittent automated measurement type. This study has only 1 arm; investigational NIBP measurements will be collected using a NIBP Auscultatory Algorithm with alternating NIBP measurements collected using a reference sphygmomanometer. | Device | Blood Pressure Collection |
Primary outcome
Collection of per subject NIBP measurements
Time frame: Start of blood pressure acquisition until three valid pairs obtained, approximately one hour
The primary objective of this study is to collect per subject NIBP measurements by oscillometric means using the GE NIBP Auscultatory Algorithm and by conventional auscultatory means in a pregnant population. These measurements include both Systolic BP (mmHg) and Diastolic BP (mmHg).
1 secondary outcome
Collection of per procedure and device log files.
Time frame: Start of blood pressure acquisition until three valid pairs obtained, approximately one hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2023.
- 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.
Nandini Raghuraman, MD principal investigator
Division of Maternal-Fetal Medicine Washington University in St Louis School of Medicine
Adithya Bhat, MD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Collecting blood pressure measurements with noninvasive blood pressure device in people with Blood Pressure, run by GE Healthcare 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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 29 Mar 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact GEHC Patient Care Solutions Research Program Integrator (+1-262-290-6037, meghan.terry@ge.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Collection of per subject NIBP measurements (time frame: Start of blood pressure acquisition until three valid pairs obtained, approximately one hour). 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 29 Mar 2023.