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NCT05093699 Clinical Trial

Dual-plane Ultrasound Imaging During Vascular Access Procedures

Vascular Access Complication Clinical Trial

Official title:
Dual-plane Ultrasound Imaging During Vascular Access Procedures

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05093699
Other study ID # 21-007039
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 1, 2022
Est. completion date March 1, 2024

Study information
Verified date April 2024
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 98
Est. completion date March 1, 2024
Est. primary completion date June 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 85 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Device:
• Butterfly iQ+ ultrasound probe
Diagnostic ultrasound probe on-market (FDA approved) capable of dual-plane viewing
• Ultrasound probe
Standard single-view ultrasound probe

Locations
Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary First-stick success rate of ultrasound-guided peripheral arterial catheter placement Number of first-stick success rate of ultrasound-guided peripheral arterial catheter placement Baseline
Secondary Number of attempts for successful cannulation Number of attempts to achieved successful arterial catheter cannulation; attempt will be defined as a single insertion of the needle into the skin. Baseline
Secondary Amount of time required for successful arterial catheter cannulation Amount of time measured in minutes for successful arterial catheter cannulation Baseline
Secondary Number of failed attempts for cannulation Number of failed attempts leading to unsuccessful arterial catheter cannulation Baseline
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