ClinicalTrials.gg
RecruitingNCT07216573Updated Jul 8, 2026

The Continuity Study

An interventional study of HemoSphere Vita Monitor with VitaWave or VitaWave Plus Finger Cuff Adult, and ForeSight Large Sensors in Blood Pressure, sponsored by Becton, Dickinson and Company. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-08.

Sponsored by Becton, Dickinson and Company · Not applicable, Interventional, and Other

From the registry’s dates

  • Started May 2026; still recruiting 6 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
188
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Blood Pressure
03

In context

Lead sponsor

Becton, Dickinson and Company is the lead sponsor of 61 studies on the registry; 5 are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 8 (80%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Signed
  2. Age ≥ 18 years
  3. (ASA) Physical Status ≥ 2
  4. Scheduled for elective noncardiac surgery with intermittent arterial blood pressure monitoring using oscillometric arm cuff

Exclusion criteria

Exclusion Criteria:

  1. Patient who is known to be pregnant
  2. Patient with existing or planned arterial pressure catheter
  3. Patient in whom systolic arterial pressure differs by more than 20 mmHg between the right and left arms
  4. Inability to place oscillometric cuff on the subject's upper extremity
  5. 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
  6. Finger or hand deformity that prevents proper placement of finger cuff by visual inspection
  7. Inability to place finger cuffs due to subject anatomy, condition, or obstructive paraphernalia (such as false nails)
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
188 participants (estimated)

Study arms

  • Experimental
    Cohort 1 - Standard of Care

    Study device data are blinded to the provider

    Device: HemoSphere Vita Monitor with VitaWave or VitaWave Plus Finger Cuff Adult, and ForeSight Large Sensors

  • Experimental
    Cohort 2 - Standard of Care with cNIBP Monitoring

    Study device continuous non-invasive blood pressure data are unblinded to the provider

    Device: HemoSphere Vita Monitor with VitaWave or VitaWave Plus Finger Cuff Adult, and ForeSight Large Sensors

Interventions

  • DeviceHemoSphere Vita Monitor with VitaWave or VitaWave Plus Finger Cuff Adult, and ForeSight Large Sensors

    Devices are applied for monitoring throughout the duration of the procedure

06

What researchers measure

Primary outcomes

  1. 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

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07216573
Responsible party
Sponsor
First posted
Oct 14, 2025
Start date
May 7, 2026
Primary completion
Jan 2027 (estimated)
Completion
Feb 2027 (estimated)
Last update
Jul 8, 2026

Study contacts

Cristina Johnson
Contact
APMContinuity.Study@bd.com
949-308-5850

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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