Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104-4283, United States
NCT Number: NCT01940354
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.
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Notify Me18 year–89 year
All sexes
Interventional
Not applicable
Philadelphia, Pennsylvania, 19104-4283, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Exclusion criteria
Vascular access and indwelling catheter placement via study device for infusion of fluids and removal of blood samples.
Other names: Rapid Intravascular Start System (RIVS), AccuCath System
Vascular access and indwelling catheter placement via control device for infusion of fluids and removal of blood samples
Time frame: Baseline/at catheter placement, PIV placement duration ranges from 3-15 minutes
Time frame: Baseline/at catheter placement; PIV placement duration ranges from 3-15 minutes
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
Time frame: Baseline/at catheter placement; PIV placement duration ranges from 3-15 minutes
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
C. R. Bard
Industry
A Prospective, Randomized, Controlled Comparison of First Attempt Success Between the AccuCath Intravenous System With Retractable Coiled Tip Guide Wire and Conventional Peripheral Intravenous Catheters With Interventional Radiology Nurses
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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