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The available SU-VEID devices expired and unable to acquire additional devices for study completion.
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The purpose of this study is to determine if use of the SU-VEID™ in children facilitates an increase success rate of peripheral intravenous starts, in comparison to the conventional method of vein entry techniques.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard IV Insertion | No Intervention | Pediatric patients in surgical pre-op requiring an IV catheter for surgery will have standard IV insertion | |
| SU-VEID assisted IV Insertion | Other | Pediatric patients in surgical pre-op requiring an IV catheter for surgery will have IV insertion using SU-VEID device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Single Use Vein Entry Indicator Device | Device | Electronic pressure sensing device, integrated to a conventional needle catheter, and which indicates continuously during intravenous cannulation whether the tip of the needle is inside or outside of a vein, to assist a clinician in intravenous cannulation. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With IV Access at First Attempt | Percentage of participants to have an IV access within the first attempt when using the SU-VEID Device in comparison to the conventional procedure | Baseline |
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Inclusion Criteria:
Exclusion Criteria:
- Patient age > 18 years old.
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| Name | Affiliation | Role |
|---|---|---|
| Michael Nemergut, MD, PhD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic 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 | Standard IV Insertion | Pediatric patients in surgical pre-op requiring an IV catheter for surgery will have standard IV insertion |
| FG001 | SU-VEID Assisted IV Insertion | Pediatric patients in surgical pre-op requiring an IV catheter for surgery will have IV insertion using SU-VEID device Single Use Vein Entry Indicator Device: Electronic pressure sensing device, integrated to a conventional needle catheter, and which indicates continuously during intravenous cannulation whether the tip of the needle is inside or outside of a vein, to assist a clinician in intravenous cannulation. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard IV Insertion | Pediatric patients in surgical pre-op requiring an IV catheter for surgery will have standard IV insertion |
| BG001 | SU-VEID Assisted IV Insertion | Pediatric patients in surgical pre-op requiring an IV catheter for surgery will have IV insertion using SU-VEID device Single Use Vein Entry Indicator Device: Electronic pressure sensing device, integrated to a conventional needle catheter, and which indicates continuously during intravenous cannulation whether the tip of the needle is inside or outside of a vein, to assist a clinician in intravenous cannulation. |
| 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 | Percentage of Participants With IV Access at First Attempt | Percentage of participants to have an IV access within the first attempt when using the SU-VEID Device in comparison to the conventional procedure | Posted | Number | percentage of participants | Baseline |
|
Adverse events were collected from baseline to end of study participation for a total of approximately 1 day on all participants.
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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 | Standard IV Insertion | Pediatric patients in surgical pre-op requiring an IV catheter for surgery will have standard IV insertion |
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Study terminated due to the the available SU-VEID devices expiring and the inability to acquire additional devices for study completion.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael E. Nemergut, M.D., Ph.D. | Mayo Clinic | 507-255-7976 | Nemergut.Michael@mayo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 15, 2021 | Mar 20, 2024 | Prot_SAP_000.pdf |
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|
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 0 |
| 84 |
| 0 |
| 84 |
| 0 |
| 84 |
| EG001 | SU-VEID Assisted IV Insertion | Pediatric patients in surgical pre-op requiring an IV catheter for surgery will have IV insertion using SU-VEID device Single Use Vein Entry Indicator Device: Electronic pressure sensing device, integrated to a conventional needle catheter, and which indicates continuously during intravenous cannulation whether the tip of the needle is inside or outside of a vein, to assist a clinician in intravenous cannulation. | 0 | 85 | 0 | 85 | 0 | 85 |
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