Blood PressureNCT07216573
The Continuity Study
A study testing HemoSphere Vita Monitor with VitaWave or VitaWave Plus Finger Cuff Adult, and ForeSight Large Sensors in people with Blood Pressure, run by Becton, Dickinson and Company at 1 site in United States.
Trial summary
A before and after interventional cohort study comparing intermittent blood pressure measurement using the oscillometric arm cuff to continuous noninvasive blood pressure (cNIBP) measurement using the VitaWave finger cuffs in subjects undergoing elective surgery in an outpatient setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blood Pressure
- What is being tested?
- HemoSphere Vita Monitor with VitaWave or VitaWave Plus Finger Cuff Adult, and ForeSight Large Sensors
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- 1 siteUnited States
- Study dates
- 7 May 2026to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Signed informed consent
- Age ≥ 18 years
- American Society of Anesthesiologists (ASA) Physical Status ≥ 2
- Scheduled for elective noncardiac surgery with intermittent arterial blood pressure monitoring using oscillometric arm cuff
Who cannot join
- Patient who is known to be pregnant
- Patient with existing or planned arterial pressure catheter
- Patient in whom systolic arterial pressure differs by more than 20 mmHg between the right and left arms
- Inability to place oscillometric cuff on the subject's upper extremity
- Extreme contraction of the smooth muscle in the arteries and arterioles of the lower arm and hand, such as may be present in patients with Raynaud's disease
- Finger or hand deformity that prevents proper placement of finger cuff by visual inspection
- Inability to place finger cuffs due to subject anatomy, condition, or obstructive paraphernalia (such as false nails)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Rochester Medical Center
Rochester, New York, 14620
About this study
Official title: Continuous Blood Pressure Monitoring During Outpatient Surgery
A before and after interventional cohort study comparing intermittent blood pressure measurement using the oscillometric arm cuff to continuous noninvasive blood pressure (cNIBP) measurement using the VitaWave finger cuffs in subjects undergoing elective surgery in an outpatient setting.
- Conditions
- Blood Pressure
- Being tested
- HemoSphere Vita Monitor with VitaWave or VitaWave Plus Finger Cuff Adult, and ForeSight Large Sensors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HemoSphere Vita Monitor with VitaWave or VitaWave Plus Finger Cuff Adult, and ForeSight Large SensorsDevice
Devices are applied for monitoring throughout the duration of the procedure
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 - Standard of Care | Experimental | Study device data are blinded to the provider Receives: Device: HemoSphere Vita Monitor with VitaWave or VitaWave Plus Finger Cuff Adult, and ForeSight Large Sensors |
| Cohort 2 - Standard of Care with cNIBP Monitoring | Experimental | Study device continuous non-invasive blood pressure data are unblinded to the provider Receives: Device: HemoSphere Vita Monitor with VitaWave or VitaWave Plus Finger Cuff Adult, and ForeSight Large Sensors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of adult patients undergoing elective noncardiac surgery in the outpatient setting who experience hypotension, defined as a mean arterial pressure (MAP) < 65 mmHg, for a total duration of at least 5 minutes.
Measured: Through Study Completion, approximately 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2025
- Study start7 May 2026
- Primary completionJan 2027 (estimated)
- Study completionFeb 2027 (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.
- 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 188 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Becton, Dickinson and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07216573
- Sponsor's protocol ID
- 2025-06
- Status last verified
- Jul 2026
- First submitted
- 19 Sep 2025
- Last updated
- 8 Jul 2026
- 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 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Blood Pressure Monitoring During Outpatient Surgery
- ClinicalTrials.gov ID
- NCT07216573
- Acronym / sponsor ID
- 2025-06
- Conditions
- Blood Pressure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 188 participants (estimated)
- Lead sponsor
- Becton, Dickinson and CompanyIndustry (pharma, biotech, devices)
- Study start
- 7 May 2026 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 14 Oct 2025 (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.
A before and after interventional cohort study comparing intermittent blood pressure measurement using the oscillometric arm cuff to continuous noninvasive blood pressure (cNIBP) measurement using the VitaWave finger cuffs in subjects undergoing elective surgery in an outpatient setting.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 - Standard of Care | Experimental | Device: HemoSphere Vita Monitor with VitaWave or VitaWave Plus Finger Cuff Adult, and ForeSight Large SensorsStudy device data are blinded to the provider |
| Cohort 2 - Standard of Care with cNIBP Monitoring | Experimental | Device: HemoSphere Vita Monitor with VitaWave or VitaWave Plus Finger Cuff Adult, and ForeSight Large SensorsStudy device continuous non-invasive blood pressure data are unblinded to the provider |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Signed informed consent
- Age ≥ 18 years
- American Society of Anesthesiologists (ASA) Physical Status ≥ 2
- Scheduled for elective noncardiac surgery with intermittent arterial blood pressure monitoring using oscillometric arm cuff
Key exclusion criteria (7 listed)
- Patient who is known to be pregnant
- Patient with existing or planned arterial pressure catheter
- Patient in whom systolic arterial pressure differs by more than 20 mmHg between the right and left arms
- Inability to place oscillometric cuff on the subject's upper extremity
- Extreme contraction of the smooth muscle in the arteries and arterioles of the lower arm and hand, such as may be present in patients with Raynaud's 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 |
|---|---|---|
| HemoSphere Vita Monitor with VitaWave or VitaWave Plus Finger Cuff Adult, and ForeSight Large SensorsDevices are applied for monitoring throughout the duration of the procedure | Device | Cohort 1 - Standard of Care, Cohort 2 - Standard of Care with cNIBP Monitoring |
Primary outcome
Percentage of adult patients undergoing elective noncardiac surgery in the outpatient setting who experience hypotension, defined as a mean arterial pressure (MAP) < 65 mmHg, for a total duration of at least 5 minutes.
Time frame: Through Study Completion, approximately 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Blood Pressure
RecruitingPhase 1
Understanding the Health Effect of a Bioactive Peptide From Egg: A Pilot Study
High Blood Sugar, High Blood Pressure
Recruiting
The Sleep2BWell Trial
Blood Pressure, Sleep Health
Enrolling by invitation
MTM2MTG Pilot Ancillary Study
Diet, Healthy, HbA1c
Recruiting
The Impact of Overnight Active Temperature Regulation on the Gut Microbiome, Inflammation, and Circadian Rhythm.
Poor Sleep Quality, Gut Microbiome
Active, not recruiting
Empowering Faith-based Communities to Provide Personalized Diabetes Self-management Education and Support (DSMES) in the Magic City
Blood Cholesterol, Blood Pressure Monitoring
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HemoSphere Vita Monitor with VitaWave or VitaWave Plus Finger Cuff Adult, and ForeSight Large Sensors in people with Blood Pressure, run by Becton, Dickinson and Company 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 4 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: looking for participants now, as of the sponsor's last update on 8 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cristina Johnson (949-308-5850, APMContinuity.Study@bd.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of adult patients undergoing elective noncardiac surgery in the outpatient setting who experience hypotension, defined as a mean arterial pressure (MAP) < 65 mmHg, for a total duration of at least 5 minutes. (time frame: Through Study Completion, approximately 12 months). 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 8 Jul 2026; AzTrials last refreshed its copy on 28 Oct 2026.