NCT06719518
Not yet recruiting
Not Applicable
Performance Evaluation of the ViTrack Continuous Non-invasive Blood Pressure Measurement Device
The University of Texas Health Science Center, Houston1 site in 1 country40 target enrollmentDecember 15, 2024
ConditionsBlood Pressure
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Blood Pressure
- Sponsor
- The University of Texas Health Science Center, Houston
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Comparison of Diastolic Blood Pressure
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
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.
Investigators
Mehmet Turan
Professor
The University of Texas Health Science Center, Houston
Eligibility Criteria
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
Outcomes
Primary Outcomes
Comparison of Diastolic Blood Pressure
Time Frame: From start of surgery up to 24 hours after surgery
255 time points compared across continuous blood pressure (mmHg)
Comparison of Systolic Blood Pressure
Time Frame: From start of surgery up to 24 hours after surgery
255 time points compared across continuous blood pressure (mmHg)
Secondary Outcomes
- Number of participants who show signs of Skin Irritation(From start of surgery up to 72 hours after surgery)
Study Sites (1)
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