NCT05093699

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
98

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 13, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 26, 2021

Completed
6 months until next milestone

Study Start

First participant enrolled

May 1, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
5 months until next milestone

Results Posted

Study results publicly available

July 31, 2024

Completed
Last Updated

June 13, 2025

Status Verified

May 1, 2025

Enrollment Period

1.1 years

First QC Date

October 13, 2021

Results QC Date

May 1, 2024

Last Update Submit

May 29, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Time to Successful First Stick in Minutes

    Number of first-stick success rate of ultrasound-guided peripheral arterial catheter placement

    Baseline

Secondary Outcomes (3)

  • Number of Attempts for Successful Cannulation

    Arterial line placement episode for surgery

  • Amount of Time Required for Successful Arterial Catheter Cannulation

    Baseline

  • Number of Failed Attempts for Cannulation

    Baseline

Study Arms (2)

Control Group

ACTIVE COMPARATOR

Arterial line placement via standard mechanism; utilization of a single-plane ultrasound probe

Device: Ultrasound probe

Butterfly iQ+ ultrasound probe

EXPERIMENTAL

Arterial line placement utilizing dual-plane, Butterfly iQ+ ultrasound probe

Device: Butterfly iQ+ ultrasound probe

Interventions

Diagnostic ultrasound probe on-market (FDA approved) capable of dual-plane viewing

Butterfly iQ+ ultrasound probe

Standard single-view ultrasound probe

Control Group

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

Results Point of Contact

Title
Dr Robert Anderson
Organization
Mayo Clinic

Study Officials

  • Robert Anderson, APRN, CNP, DNP

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 13, 2021

First Posted

October 26, 2021

Study Start

May 1, 2022

Primary Completion

June 1, 2023

Study Completion

March 1, 2024

Last Updated

June 13, 2025

Results First Posted

July 31, 2024

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations