The Continuity Study

Purpose

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.

Condition

  • Blood Pressure

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

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)

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Other
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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
    Devices are applied for monitoring throughout the duration of the procedure
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
    Devices are applied for monitoring throughout the duration of the procedure

Recruiting Locations

University of Rochester Medical Center
Rochester, New York 14620

More Details

Status
Recruiting
Sponsor
Becton, Dickinson and Company

Study Contact

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