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Non-invasive vs Invasive Blood Pressure Monitoring During Surgery and ICU Care

N/A
Recruiting
Led By James A Scott, MD
Research Sponsored by University of Massachusetts, Worcester
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients between the ages of 18 - 90 years age who are undergoing any surgery or in the intensive care unit and require intra-arterial catheterization for continuous BP measurement.
Patients having elective surgeries.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 72 hours
Awards & highlights
No Placebo-Only Group

Summary

This trial compares a new continuous blood pressure measurement device to the standard radial artery catheterization method in patients undergoing surgery or in the intensive care unit.

Who is the study for?
This trial is for adults aged 18-90 who need their blood pressure monitored during surgery or in the ICU. It's open to those having elective or emergency surgeries, provided they can understand and sign a consent form beforehand, or have a guardian do so if necessary.
What is being tested?
The study is testing ViTrack, a noninvasive blood pressure monitor, against the standard invasive method using a radial artery catheter. The goal is to see how well ViTrack compares in accuracy and safety during surgical procedures and intensive care.
What are the potential side effects?
While ViTrack should not cause side effects as it's noninvasive, the standard radial artery catheterization may lead to complications like bleeding at the puncture site, infection, or damage to the artery.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 90 years old and need a catheter for BP monitoring due to surgery or ICU stay.
Select...
I am scheduled for a planned surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 72 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 72 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Comparison of Diastolic Blood Pressure
Comparison of Systolic Blood Pressure
Secondary study objectives
Skin Irritation

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Wrist oneExperimental Treatment1 Intervention
Wrist one will have both the ViTrack wrist cuff on one wrist
Group II: Wrist TwoActive Control1 Intervention
Wrist two and the radial artery catheter in the opposite wrist.

Find a Location

Who is running the clinical trial?

University of Massachusetts, WorcesterLead Sponsor
361 Previous Clinical Trials
992,911 Total Patients Enrolled
James A Scott, MDPrincipal InvestigatorUniversity of Massachusetts, Worcester
James A Scott, DOPrincipal InvestigatorUniversity of Massachusetts, Worcester

Media Library

ViTrack Clinical Trial Eligibility Overview. Trial Name: NCT04506775 — N/A
Intensive Care Unit Research Study Groups: Wrist one, Wrist Two
Intensive Care Unit Clinical Trial 2023: ViTrack Highlights & Side Effects. Trial Name: NCT04506775 — N/A
ViTrack 2023 Treatment Timeline for Medical Study. Trial Name: NCT04506775 — N/A
~5 spots leftby Nov 2025
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