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

NCT06805435 | Completed FDA Device

• 1 other identifier: 2219626-3
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Acumen IQ cuff; continuous non-invasive blood pressure monitoring; Toe

Outcome Measures

Primary Outcomes (1)

• Comparison between output from the continuous non-invasive blood pressure cuff placed on the volunteers index finger compared to the output from the continuous non-invasive blood pressure cuff placed on the volunteers 2nd toe.

  The continuous non-invasive blood pressure cuff measures mean arterial pressure which will be compared between the index finger and 2nd toe of the same volunteer.

  Continuous non-invasive blood pressure measurements will be collected for 10 minutes

Secondary Outcomes (2)

• Effects of length and circumference of the middle phalanx of the 2nd toe on the accuracy of the continuous non-invasive blood pressure cuff measurements compared to the measurements taken from the index finger.

  Continuous non-invasive blood pressure measurements will be collected for 10 minutes.

• Validity of the continuous non-invasive blood pressure monitoring cuff on the toe compared to automatic blood pressure cuff measurements on the contralateral lower extremity.

  Continuous non-invasive blood pressure measurements will be collected for 10 minutes

Study Arms (1)

Healthy volunteers

Healthy volunteers consisting of medical students and residents at our institution.

Device: Continuous non-invasive blood pressure monitoring

Interventions

Continuous non-invasive blood pressure monitoring DEVICE

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

Healthy volunteers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consistent of a convenience sample of available healthy volunteer medical students or residents.

You may qualify if:

• years or older
• Medical student or resident

You may not qualify if:

• Medical history of Raynaud's or peripheral vascular disease
• Allergy to adhesive

Sponsors & Collaborators

• Riverside University Health System Medical Center: lead

Study Sites (1)

Riverside University Health System Medical Center

Moreno Valley, California, 92555, United States

Location

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Coordinator

Study Record Dates

• First Submitted: January 28, 2025
• First Posted: February 3, 2025
• Study Start: January 29, 2025
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2025
• Last Updated: February 7, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)