Vascular Access ComplicationNCT05093699
Dual-plane Ultrasound Imaging During Vascular Access Procedures
A study testing Butterfly iQ+ ultrasound probe and Ultrasound probe in people with Vascular Access Complication, run by Mayo Clinic at 1 site in United States.
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 Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Vascular Access Complication
- What is being tested?
- Butterfly iQ+ ultrasound probe and Ultrasound probe
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2022to 1 Mar 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
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
- Conditions
- Vascular Access Complication
- Being tested
- Butterfly iQ+ ultrasound probe, Ultrasound probe
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Butterfly iQ+ ultrasound probeDevice
Diagnostic ultrasound probe on-market (FDA approved) capable of dual-plane viewing
Ultrasound probeDevice
Standard single-view ultrasound probe
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Arterial line placement via standard mechanism; utilization of a single-plane ultrasound probe Receives: Device: Ultrasound probe |
| Butterfly iQ+ ultrasound probe | Experimental | Arterial line placement utilizing dual-plane, Butterfly iQ+ ultrasound probe Receives: Device: Butterfly iQ+ ultrasound probe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Successful First Stick in Minutes
Number of first-stick success rate of ultrasound-guided peripheral arterial catheter placement
Measured: Baseline
Secondary outcomes (3)
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.
Measured: Arterial line placement episode for surgery
Amount of Time Required for Successful Arterial Catheter Cannulation
Amount of time measured in minutes for successful arterial catheter cannulation
Measured: Baseline
Number of Failed Attempts for Cannulation
Number of failed attempts leading to unsuccessful arterial catheter cannulation
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2021
- Study start1 May 2022
- Primary completion1 Jun 2023
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Vascular Access ComplicationStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert (Bobby) J. Anderson, Mayo Clinic
- Investigators
- Robert Anderson, APRN, CNP, DNP, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05093699
- Sponsor's protocol ID
- 21-007039
- Status last verified
- May 2025
- First submitted
- 13 Oct 2021
- Last updated
- 13 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dual-plane Ultrasound Imaging During Vascular Access Procedures
- ClinicalTrials.gov ID
- NCT05093699
- Acronym / sponsor ID
- 21-007039
- Conditions
- Vascular Access Complication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 26 Oct 2021 (actual)
- Results
- Posted 31 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Device: Ultrasound probeArterial line placement via standard mechanism; utilization of a single-plane ultrasound probe |
| Butterfly iQ+ ultrasound probe | Experimental | Device: Butterfly iQ+ ultrasound probeArterial line placement utilizing dual-plane, Butterfly iQ+ ultrasound probe |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Butterfly iQ+ ultrasound probeDiagnostic ultrasound probe on-market (FDA approved) capable of dual-plane viewing | Device | Butterfly iQ+ ultrasound probe |
| Ultrasound probeStandard single-view ultrasound probe | Device | Control Group |
Primary outcome
Time to Successful First Stick in Minutes
Time frame: Baseline
Number of first-stick success rate of ultrasound-guided peripheral arterial catheter placement
3 secondary outcomes
Number of Attempts for Successful Cannulation
Time frame: Arterial line placement episode for surgery
Amount of Time Required for Successful Arterial Catheter Cannulation
Time frame: Baseline
Number of Failed Attempts for Cannulation
Time frame: Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Mayo Clinic - Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Anderson, APRN, CNP, DNP principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Butterfly iQ+ ultrasound probe and Ultrasound probe in people with Vascular Access Complication, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Successful First Stick in Minutes (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2025.