Dual-plane Ultrasound Imaging During Vascular Access Procedures

April 23, 2024 updated by: Robert (Bobby) J. Anderson, Mayo Clinic
Researchers are evaluating the clinical efficiency of utilization of a dual-plane simultaneous view ultrasound probe (Butterfly iQ+; Butterfly Network, Inc.) during arterial catheter placement in the operating room

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

98

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion criteria

  • Patient: Elective surgical patients requiring non-emergent ultrasound-guided radial arterial catheter placement
  • Providers: Anesthesia providers to include trainees, certified registered nurse anesthetists (CRNA) and attending anesthesia providers.

Exclusion Criteria

  • Patient
  • Pregnant
  • Patients in a moribund state or palliative care only
  • Vulnerable patients (i.e. Severe mental handicap, non-decisional)
  • History of peripheral arterial disease
  • Placement of arterial catheter without ultrasound guidance
  • Provider: Medical students or CRNA students.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control Group
Arterial line placement via standard mechanism; utilization of a single-plane ultrasound probe
Device: Ultrasound probe
Standard single-view ultrasound probe
Experimental: Butterfly iQ+ ultrasound probe
Arterial line placement utilizing dual-plane, Butterfly iQ+ ultrasound probe
Device: Butterfly iQ+ ultrasound probe
Diagnostic ultrasound probe on-market (FDA approved) capable of dual-plane viewing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
First-stick success rate of ultrasound-guided peripheral arterial catheter placement
Time Frame: Baseline
Number of first-stick success rate of ultrasound-guided peripheral arterial catheter placement
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of attempts for successful cannulation
Time Frame: Baseline
Number of attempts to achieved successful arterial catheter cannulation; attempt will be defined as a single insertion of the needle into the skin.
Baseline
Amount of time required for successful arterial catheter cannulation
Time Frame: Baseline
Amount of time measured in minutes for successful arterial catheter cannulation
Baseline
Number of failed attempts for cannulation
Time Frame: Baseline
Number of failed attempts leading to unsuccessful arterial catheter cannulation
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Robert Anderson, APRN, CNP, DNP, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2022

Primary Completion (Actual)

June 1, 2023

Study Completion (Actual)

March 1, 2024

Study Registration Dates

First Submitted

October 13, 2021

First Submitted That Met QC Criteria

October 13, 2021

First Posted (Actual)

October 26, 2021

Study Record Updates

Last Update Posted (Actual)

April 25, 2024

Last Update Submitted That Met QC Criteria

April 23, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 21-007039

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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