Recruiting NCT07216573
The Continuity Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HemoSphere Vita Monitor with VitaWave or VitaWave Plus Finger Cuff Adult, and ForeSight Large Sensors.
- Who it may be relevant to
- Registry conditions: Blood Pressure. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Continuous Blood Pressure Monitoring During Outpatient Surgery
Overview
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.
Interventions
- Device HemoSphere 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
Primary outcome measures
- 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]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 1 center
- University of Rochester Medical Center — Rochester
Identifiers
NCT: NCT07216573 · 2025-06