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Recruiting

NCT Number: NCT07216573

The Continuity Study

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.

Recruiting

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Rochester Medical Center

Rochester, New York, 14620, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

Device

Devices are applied for monitoring throughout the duration of the procedure

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

Study contacts

Contact information is provided by the study sponsor or research team.

Cristina Johnson

CONTACT

[email protected]

949-308-5850

Sponsors and collaborators

Lead sponsor

Becton, Dickinson and Company

Industry

Registry information

Official study title

Continuous Blood Pressure Monitoring During Outpatient Surgery

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Oct 14, 2025
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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