Trial Outcomes & Findings for Dual-plane Ultrasound Imaging During Vascular Access Procedures (NCT NCT05093699)
NCT ID: NCT05093699
Last Updated: 2025-06-13
Results Overview
Number of first-stick success rate of ultrasound-guided peripheral arterial catheter placement
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
98 participants
Primary outcome timeframe
Baseline
Results posted on
2025-06-13
Participant Flow
Participant milestones
| Measure |
Control Group
Arterial line placement via standard mechanism; utilization of a single-plane ultrasound probe
Ultrasound probe: Standard single-view ultrasound probe
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
48
|
|
Overall Study
COMPLETED
|
50
|
48
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Dual-plane Ultrasound Imaging During Vascular Access Procedures
Baseline characteristics by cohort
| Measure |
Control Group
n=50 Participants
Arterial line placement via standard mechanism; utilization of a single-plane ultrasound probe
Ultrasound probe: Standard single-view ultrasound probe
|
Butterfly iQ+ Ultrasound Probe
n=48 Participants
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
|
Total
n=98 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50 years
n=93 Participants
|
50 years
n=4 Participants
|
50 years
n=27 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=93 Participants
|
24 Participants
n=4 Participants
|
49 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=93 Participants
|
24 Participants
n=4 Participants
|
49 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
50 Participants
n=93 Participants
|
48 Participants
n=4 Participants
|
98 Participants
n=27 Participants
|
|
Analyzed
|
50 Participants
n=93 Participants
|
48 Participants
n=4 Participants
|
98 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: BaselineNumber of first-stick success rate of ultrasound-guided peripheral arterial catheter placement
Outcome measures
| Measure |
Control Group
n=50 Participants
Arterial line placement via standard mechanism; utilization of a single-plane ultrasound probe
Ultrasound probe: Standard single-view ultrasound probe
|
Butterfly iQ+ Ultrasound Probe
n=48 Participants
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
|
|---|---|---|
|
Time to Successful First Stick in Minutes
|
4.56 minutes
Standard Deviation 3.95
|
6.24 minutes
Standard Deviation 5.36
|
SECONDARY outcome
Timeframe: Arterial line placement episode for surgeryNumber of attempts to achieved successful arterial catheter cannulation; attempt will be defined as a single insertion of the needle into the skin.
Outcome measures
| Measure |
Control Group
n=50 Participants
Arterial line placement via standard mechanism; utilization of a single-plane ultrasound probe
Ultrasound probe: Standard single-view ultrasound probe
|
Butterfly iQ+ Ultrasound Probe
n=48 Participants
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
|
|---|---|---|
|
Number of Attempts for Successful Cannulation
|
48 Successful arterial line placement
|
39 Successful arterial line placement
|
SECONDARY outcome
Timeframe: BaselineAmount of time measured in minutes for successful arterial catheter cannulation
Outcome measures
| Measure |
Control Group
n=50 Participants
Arterial line placement via standard mechanism; utilization of a single-plane ultrasound probe
Ultrasound probe: Standard single-view ultrasound probe
|
Butterfly iQ+ Ultrasound Probe
n=48 Participants
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
|
|---|---|---|
|
Amount of Time Required for Successful Arterial Catheter Cannulation
|
4.56 minutes
Interval 0.2 to 18.01
|
6.24 minutes
Interval 0.42 to 22.54
|
SECONDARY outcome
Timeframe: BaselineNumber of failed attempts leading to unsuccessful arterial catheter cannulation
Outcome measures
| Measure |
Control Group
n=50 Participants
Arterial line placement via standard mechanism; utilization of a single-plane ultrasound probe
Ultrasound probe: Standard single-view ultrasound probe
|
Butterfly iQ+ Ultrasound Probe
n=48 Participants
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
|
|---|---|---|
|
Number of Failed Attempts for Cannulation
|
2 number of failed attempts
|
9 number of failed attempts
|
Adverse Events
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Butterfly iQ+ Ultrasound Probe
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place