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Dual-plane Ultrasound Imaging During Vascular Access Procedures

Sponsor
Mayo Clinic (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05093699
Collaborator
(none)
150
Enrollment
1
Location
2
Arms
10
Anticipated Duration (Months)
15
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Device: Butterfly iQ+ ultrasound probe
  • Device: Ultrasound probe
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Dual-plane Ultrasound Imaging During Vascular Access Procedures
Actual Study Start Date :
May 1, 2022
Anticipated Primary Completion Date :
Mar 1, 2023
Anticipated Study Completion Date :
Mar 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Control Group

Arterial line placement via standard mechanism; utilization of a single-plane ultrasound probe

Device: Ultrasound probe
Standard single-view ultrasound probe
Experimental: Butterfly iQ+ ultrasound probe

Arterial line placement utilizing dual-plane, Butterfly iQ+ ultrasound probe

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

Outcome Measures

Primary Outcome Measures

  1. First-stick success rate of ultrasound-guided peripheral arterial catheter placement [Baseline]

    Number of first-stick success rate of ultrasound-guided peripheral arterial catheter placement

Secondary Outcome Measures

  1. Number of attempts for successful cannulation [Baseline]

    Number of attempts to achieved successful arterial catheter cannulation; attempt will be defined as a single insertion of the needle into the skin.

  2. Amount of time required for successful arterial catheter cannulation [Baseline]

    Amount of time measured in minutes for successful arterial catheter cannulation

  3. Number of failed attempts for cannulation [Baseline]

    Number of failed attempts leading to unsuccessful arterial catheter cannulation

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 85 Years
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mayo Clinic in Rochester Rochester Minnesota United States 55905

Sponsors and Collaborators

  • Mayo Clinic

Investigators

  • Principal Investigator: Robert Anderson, APRN, CNP, DNP, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Robert (Bobby) J. Anderson, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT05093699
Other Study ID Numbers:
  • 21-007039
First Posted:
Oct 26, 2021
Last Update Posted:
Jun 30, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No

Study Results

No Results Posted as of Jun 30, 2022