Dual-plane Ultrasound Imaging During Vascular Access Procedures

NCT ID: NCT05093699

Last Updated: 2025-06-13

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-01

Study Completion Date

2024-03-01

Brief Summary

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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

Detailed Description

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Conditions

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Vascular Access Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Control Group

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

Group Type ACTIVE_COMPARATOR

Ultrasound probe

Intervention Type DEVICE

Standard single-view ultrasound probe

Butterfly iQ+ ultrasound probe

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

Group Type EXPERIMENTAL

Butterfly iQ+ ultrasound probe

Intervention Type DEVICE

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

Interventions

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Butterfly iQ+ ultrasound probe

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

Intervention Type DEVICE

Ultrasound probe

Standard single-view ultrasound probe

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Robert (Bobby) J. Anderson

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Robert Anderson, APRN, CNP, DNP

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Related Links

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Other Identifiers

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21-007039

Identifier Type: -

Identifier Source: org_study_id

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