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The study will test a hypothesis that the AccuCath™ System will have a higher rate of successful first attempt peripheral IV placement and higher clinician and patient satisfaction compared to Conventional IV Catheters.
This study is designed to evaluate user/physician preference as it relates to use of a 510(k) cleared vascular access peripheral IV catheter device compared with peripheral IV conventional needle/catheter devices, in terms of first stick success rates, adverse events and overall user and patient satisfaction. As noted above, the study is designed to formally test the hypothesis that the AccuCath™ System will exhibit superiority in terms of the rate of successful first attempt peripheral IV placement and higher user and patient satisfaction compared to Conventional IV Catheters.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vascular access via study device | Experimental | AccuCath IV Catheter System will be used for IV therapy during interventional radiology procedure. Intervention includes vascular access, fluid infusion, and blood sample removal. |
|
| Vascular access via control device | Active Comparator | Conventional IV Catheter System (current catheter) will be used for IV therapy during interventional radiology procedure. Interventions include vascular access, administration of fluids, and blood sample removal. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AccuCath IV Catheter System | Device | Vascular access and indwelling catheter placement via study device for infusion of fluids and removal of blood samples. |
|
| Measure | Description | Time Frame |
|---|---|---|
| First Attempt Success Rate With Peripheral IV (PIV) Catheter Placement | Baseline/at catheter placement, PIV placement duration ranges from 3-15 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Satisfaction Upon Successful PIV Placement | Patient Satisfaction was measured at initial PIV placement using a 5 Point Likert Scale: 5 - Very Comfortable, 4 - Somewhat Comfortable, 3 - Neutral, 2- Somewhat Uncomfortable, 1 - Very Uncomfortable | Baseline/at catheter placement; PIV placement duration ranges from 3-15 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Scott O Trerotola, BA, MD | University of Pennsylvania | Principal Investigator |
| William Stavropoulos, MD | Hosptial of the University of Pennsylvania | Principal Investigator |
| Suzanne Sweeney, RN | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104-4283 | United States |
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Enrollment occurred from April 2013 - November 2013. Location was Interventional Radiology Department at participating hospital.
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| ID | Title | Description |
|---|---|---|
| FG000 | Vascular Access Via Study Device | AccuCath IV Catheter System will be used for IV therapy during interventional radiology procedure. Intervention includes vascular access, fluid infusion, and blood sample removal. AccuCath IV device: Vascular access and indwelling catheter placement via study device for infusion of fluids and removal of blood samples. |
| FG001 | Vascular Access Via Control Device | Conventional IV Catheter (current catheter) will be used for IV therapy during interventional radiology procedure. Interventions include vascular access, administration of fluids, and blood sample removal. Conventional IV catheters: Vascular access and indwelling catheter placement via control device for infusion of fluids and removal of blood samples |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Vascular Access Via Study Device | AccuCath IV Catheter System will be used for IV therapy during interventional radiology procedure. Intervention includes vascular access, fluid infusion, and blood sample removal. AccuCath IV device: Vascular access and indwelling catheter placement via study device for infusion of fluids and removal of blood samples. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | First Attempt Success Rate With Peripheral IV (PIV) Catheter Placement | Posted | Count of Participants | Participants | Baseline/at catheter placement, PIV placement duration ranges from 3-15 minutes |
|
Adverse event data were collected for each participant from post-PIV placement until catheter removal (up to 14 days).
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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 | Vascular Access Via Study Device | AccuCath IV Catheter System will be used for IV therapy during interventional radiology procedure. Intervention includes vascular access, fluid infusion, and blood sample removal. AccuCath IV device: Vascular access and indwelling catheter placement via study device for infusion of fluids and removal of blood samples. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infiltration | Vascular disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Scott Trerotola, MD | Hospital of the University of Pennsylvania | 215-662-6983 | scott.trerotola@uphs.upenn.edu |
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|
| Conventional IV Catheter System | Device | Vascular access and indwelling catheter placement via control device for infusion of fluids and removal of blood samples |
|
| Clinician Satisfaction Upon Successful PIV Placement |
Clinician Satisfaction was measured at initial PIV placement using a 5 Point Likert Scale: "How easy was the AccuCath™ System to use in comparison to the current catheter?" 5 - Easier to Use 4 - Somewhat Easier to Use 3 - Neutral 2 - Somewhat Difficult to Use 1 - Very Difficult to Use |
| Baseline/at catheter placement; PIV placement duration ranges from 3-15 minutes |
| BG001 |
| Vascular Access Via Control Device |
Conventional IV Catheter (current catheter) will be used for IV therapy during interventional radiology procedure. Interventions include vascular access, administration of fluids, and blood sample removal. Conventional IV catheters: Vascular access and indwelling catheter placement via control device for infusion of fluids and removal of blood samples |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
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| Secondary | Patient Satisfaction Upon Successful PIV Placement | Patient Satisfaction was measured at initial PIV placement using a 5 Point Likert Scale: 5 - Very Comfortable, 4 - Somewhat Comfortable, 3 - Neutral, 2- Somewhat Uncomfortable, 1 - Very Uncomfortable | The number of patients analyzed in each group differs from the numbers in the Participant Flow due to missing data (n = 6 in Study Device arm and n = 1 in the Control Arm). | Posted | Mean | Standard Deviation | units on a scale | Baseline/at catheter placement; PIV placement duration ranges from 3-15 minutes |
|
|
|
| Secondary | Clinician Satisfaction Upon Successful PIV Placement | Clinician Satisfaction was measured at initial PIV placement using a 5 Point Likert Scale: "How easy was the AccuCath™ System to use in comparison to the current catheter?" 5 - Easier to Use 4 - Somewhat Easier to Use 3 - Neutral 2 - Somewhat Difficult to Use 1 - Very Difficult to Use | The number of patients analyzed in each group differs from the numbers in the Participant Flow due to missing data (n = 5 in Study Device arm and n = 1 in the Control Arm). | Posted | Mean | Standard Deviation | units on a scale | Baseline/at catheter placement; PIV placement duration ranges from 3-15 minutes |
|
|
|
| 0 |
| 110 |
| 0 |
| 110 |
| 2 |
| 110 |
| EG001 | Vascular Access Via Control Device | Conventional IV Catheter (current catheter) will be used for IV therapy during interventional radiology procedure. Interventions include vascular access, administration of fluids, and blood sample removal. Conventional IV catheters: Vascular access and indwelling catheter placement via control device for infusion of fluids and removal of blood samples. | 0 | 110 | 0 | 110 | 10 | 110 |
| Hematoma | Vascular disorders | Non-systematic Assessment |
|
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