Vascular Access Complication
Conditions
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
Interventions
DEVICEButterfly iQ+ ultrasound probe
Diagnostic ultrasound probe on-market (FDA approved) capable of dual-plane viewing
DEVICEUltrasound probe
Standard single-view ultrasound probe
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Successful First Stick in Minutes | Baseline | Number of first-stick success rate of ultrasound-guided peripheral arterial catheter placement |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Attempts for Successful Cannulation | Arterial line placement episode for surgery | Number of attempts to achieved successful arterial catheter cannulation; attempt will be defined as a single insertion of the needle into the skin. |
| Amount of Time Required for Successful Arterial Catheter Cannulation | Baseline | Amount of time measured in minutes for successful arterial catheter cannulation |
| Number of Failed Attempts for Cannulation | Baseline | Number of failed attempts leading to unsuccessful arterial catheter cannulation |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Group Arterial line placement via standard mechanism; utilization of a single-plane ultrasound probe
Ultrasound probe: Standard single-view ultrasound probe | 50 |
| Butterfly iQ+ Ultrasound Probe Arterial line placement utilizing dual-plane, Butterfly iQ+ ultrasound probe
Butterfly iQ+ ultrasound probe: Diagnostic ultrasound probe on-market (FDA approved) capable of dual-plane viewing | 48 |
| Total | 98 |
Baseline characteristics
| Characteristic | Control Group | Butterfly iQ+ Ultrasound Probe | Total |
|---|---|---|---|
| Age, Continuous | 50 years | 50 years | 50 years |
| Analyzed | 50 Participants | 48 Participants | 98 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 50 Participants | 48 Participants | 98 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 25 Participants | 24 Participants | 49 Participants |
| Sex: Female, Male Male | 25 Participants | 24 Participants | 49 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 48 |
| other Total, other adverse events | 0 / 50 | 0 / 48 |
| serious Total, serious adverse events | 0 / 50 | 0 / 48 |
Outcome results
Primary
Time to Successful First Stick in Minutes
Number of first-stick success rate of ultrasound-guided peripheral arterial catheter placement
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Time to Successful First Stick in Minutes | 4.56 minutes | Standard Deviation 3.95 |
| Butterfly iQ+ Ultrasound Probe | Time to Successful First Stick in Minutes | 6.24 minutes | Standard Deviation 5.36 |
Secondary
Amount of Time Required for Successful Arterial Catheter Cannulation
Amount of time measured in minutes for successful arterial catheter cannulation
Time frame: Baseline
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Control Group | Amount of Time Required for Successful Arterial Catheter Cannulation | 4.56 minutes |
| Butterfly iQ+ Ultrasound Probe | Amount of Time Required for Successful Arterial Catheter Cannulation | 6.24 minutes |
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.
Time frame: Arterial line placement episode for surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control Group | Number of Attempts for Successful Cannulation | 48 Successful arterial line placement |
| Butterfly iQ+ Ultrasound Probe | Number of Attempts for Successful Cannulation | 39 Successful arterial line placement |
Secondary
Number of Failed Attempts for Cannulation
Number of failed attempts leading to unsuccessful arterial catheter cannulation
Time frame: Baseline
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control Group | Number of Failed Attempts for Cannulation | 2 number of failed attempts |
| Butterfly iQ+ Ultrasound Probe | Number of Failed Attempts for Cannulation | 9 number of failed attempts |