MedPath

Performance Evaluation of the ViTrack Continuous Non-invasive Blood Pressure Measurement Device

Not yet recruiting
Conditions
Blood Pressure
Registration Number
NCT06719518
Lead Sponsor
The University of Texas Health Science Center, Houston
Brief Summary

The purpose of this study is to calibrate the ViTrack™ arterial pressure waveform against intra-arterial pressure (IAP) in dynamic clinical settings and to assess the optimized ViTrack™ design to measure and continuously track blood pressure over a wide, clinically-relevant pressure range.

Detailed Description

Not available

Recruitment & Eligibility

Status
NOT_YET_RECRUITING
Sex
All
Target Recruitment
40
Inclusion Criteria
  • scheduled to undergo noncardiac surgery with general or spinal anesthesia
  • clinical indication for invasive intra-arterial pressure monitoring
  • palpable pulse
Exclusion Criteria
  • difference of greater than 10 mmHg in the left versus right arm oscillometric systolic blood pressure
  • Upper extremity arteriovenous hemodialysis shunt
  • Upper extremity amputation
  • Planned surgical position/draping that precludes access to the wrist
  • Wrist distortion or pain from arthritis
  • Prior trauma or surgery at the radial artery monitoring site
  • Unable to provide informed consent
  • Clinical contraindication as determined by the clinical team or study investigators

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Comparison of Diastolic Blood PressureFrom start of surgery up to 24 hours after surgery

255 time points compared across continuous blood pressure (mmHg)

Comparison of Systolic Blood PressureFrom start of surgery up to 24 hours after surgery

255 time points compared across continuous blood pressure (mmHg)

Secondary Outcome Measures
NameTimeMethod
Number of participants who show signs of Skin IrritationFrom start of surgery up to 72 hours after surgery

Trial Locations

Locations (1)

The University of Texas Health Science Center at Houston

🇺🇸

Houston, Texas, United States

© Copyright 2025. All Rights Reserved by MedPath