Dual-plane Ultrasound Imaging During Vascular Access Procedures

Study Overview
=================
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

Official Title
-----------------
Dual-plane Ultrasound Imaging During Vascular Access Procedures

Conditions
-----------------
Vascular Access Complication

Intervention / Treatment
-----------------
* Device: Butterfly iQ+ ultrasound probe
* Device: Ultrasound probe


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

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

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 | 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 | 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 | Amount of time measured in minutes for successful arterial catheter cannulation | Baseline | 
| Number of failed attempts for cannulation | Number of failed attempts leading to unsuccessful arterial catheter cannulation | Baseline |