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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | Active Comparator | Arterial line placement via standard mechanism; utilization of a single-plane ultrasound probe |
|
| Butterfly iQ+ ultrasound probe | Experimental | Arterial line placement utilizing dual-plane, Butterfly iQ+ ultrasound probe |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Butterfly iQ+ ultrasound probe | Device | Diagnostic ultrasound probe on-market (FDA approved) capable of dual-plane viewing |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to Successful First Stick in Minutes | Number of first-stick success rate of ultrasound-guided peripheral arterial catheter placement | Baseline |
| 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. | Arterial line placement episode for surgery |
| Amount of Time Required for Successful Arterial Catheter Cannulation |
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Inclusion criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Robert Anderson, APRN, CNP, DNP | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic - Clinical Trials | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Group | Arterial line placement via standard mechanism; utilization of a single-plane ultrasound probe Ultrasound probe: Standard single-view ultrasound probe |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control Group | Arterial line placement via standard mechanism; utilization of a single-plane ultrasound probe Ultrasound probe: Standard single-view ultrasound probe |
| BG001 | Butterfly iQ+ Ultrasound Probe |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time to Successful First Stick in Minutes | Number of first-stick success rate of ultrasound-guided peripheral arterial catheter placement | Posted | Mean | Standard Deviation | minutes | Baseline |
|
Total study - 6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control Group | Arterial line placement via standard mechanism; utilization of a single-plane ultrasound probe Ultrasound probe: Standard single-view ultrasound probe |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Robert Anderson | Mayo Clinic | 507-284-4341 | anderson.robert2@mayo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 2, 2021 | Jul 8, 2024 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 1, 2023 | Jul 30, 2024 | SAP_003.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 12, 2021 | May 1, 2024 | ICF_001.pdf |
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| Ultrasound probe | Device | Standard single-view ultrasound probe |
|
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 |
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
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Analyzed | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 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. | Posted | Number | Successful arterial line placement | Arterial line placement episode for surgery |
|
|
|
| Secondary | Amount of Time Required for Successful Arterial Catheter Cannulation | Amount of time measured in minutes for successful arterial catheter cannulation | Posted | Mean | Full Range | minutes | Baseline |
|
|
|
| Secondary | Number of Failed Attempts for Cannulation | Number of failed attempts leading to unsuccessful arterial catheter cannulation | Posted | Number | number of failed attempts | Baseline |
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| 0 |
| 50 |
| 0 |
| 50 |
| 0 |
| 50 |
| EG001 | 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 | 0 | 48 | 0 | 48 | 0 | 48 |
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