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Is Continuous Non-Invasive Monitoring Accurate When Used on the Lower Extremity: Finger Vs Toe?

NCT06805435 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2025-02-07

No results posted yet for this study

Summary

The goal of this observational study is to assess the validity of a continuous non-invasive blood pressure monitoring device, Acumen IQ cuff (Edwards Lifesciences LLC, Irvine, CA), when used on the toe in healthy volunteers. The main questions it aims to answer is:

• Can a continuous non-invasive blood pressure monitoring device accurately measure hemodynamic parameters when placed on a toe as compared to the finger in a healthy volunteer?

Secondary Outcomes:

* What are the effects of length and circumference of the middle phalanx of the 2nd toe on the accuracy of the Acumen IQ cuff (Edwards Lifesciences LLC, Irvine, CA) measurements compared to the measurements taken from the finger?
* What are the effects of a Valsalva maneuver on the measurements taken from the Acumen IQ cuff (Edwards Lifesciences LLC, Irvine, CA) on a toe compared to the Acumen IQ cuff (Edwards Lifesciences LLC, Irvine, CA) placed on the finger.

Participants will:

* Have blood pressures taken using an automatic blood pressure cuff (both arms and both calves)
* Have a continuous non-invasive blood pressure monitoring sensor placed on their finger and toe simultaneously for 10 minutes
* Be asked to valsalva briefly to induce a change in blood pressure to be observed by the dual sensors

Conditions

  • Validation
  • Blood Pressure
  • Device

Interventions

DEVICE

Continuous non-invasive blood pressure monitoring

A continuous non-invasive blood pressure monitoring cuff will be placed on the volunteers index finger (as intended) and 2nd toe (primary outcome).

Sponsors & Collaborators

  • Riverside University Health System Medical Center

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-01-29
Primary Completion
2025-02-01
Completion
2025-02-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06805435 on ClinicalTrials.gov