RecruitingNot Applicable

The Continuity Study

United States188 participantsStarted 2026-05-07

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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

Exclusion criteria

. 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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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.

Timeframe: Through Study Completion, approximately 12 months

Trial details

NCT IDNCT07216573

SponsorEdwards Lifesciences

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-01

Contact for this trial

Cristina Johnson

949-308-5850 APMContinuity.Study@bd.com

View on ClinicalTrials.gov More Blood Pressure trials