N/A
N=238
Study of Effectiveness of Smaller Gauge Fenestrated Catheters for Use in IV Contrast Enhanced CT Scans
Contrast Enhanced Computed Tomography
Bottom Line
View on ClinicalTrials.gov: NCT01772550 ↗Enrolled (actual)
238
Serious AEs
0.0%
Results posted
Mar 2014
Primary outcome: Primary: Acceptable Image Quality — 100; 100; 100 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- 20GA BD Nexiva Diffusics (Device); 18GA Conventional Catheter (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Becton, Dickinson and Company
- Primary completion
- Feb 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Acceptable Image Quality |
100; 100; 100 | — |
| SECONDARY Abdomen CT - Average Hounsfield Units as a Measure of Aortic Contrast Delivery and Enhancement in Randomized Subjects |
400.9; 402.5 | — |
| SECONDARY Chest CT - Average Hounsfield Units as a Measure of Aortic Contrast Delivery and Enhancement in Subjects Whose Veins Could Accommodate an 18 GA IV Catheter (Randomized Subjects) |
428.9; 402.2 | — |
| SECONDARY Complete Chest and Abdomen CT - Average Hounsfield Units as a Measure of Aortic Contrast Delivery and Enhancement in Subjects Whose Veins Could Accommodate an 18 GA IV Catheter (Randomized Subjects) |
373.2; 387.7 | — |
| SECONDARY Maximum Flow Rate |
5.58; 5.74; 5.46 | — |
| SECONDARY Catheter Insertion Success |
96; 100; 20; 5; 2; 8 | — |
| SECONDARY Extravasation of Contrast Media |
0; 0; 1 | — |
| SECONDARY Automatic Injection Shutoff |
0; 0; 0 | — |
| SECONDARY High Pressure Alarm |
0; 1; 1 | — |
| SECONDARY Catheter Dislodgement |
0; 0; 0 | — |
| SECONDARY Catheter Transfixation |
0; 0; 0 | — |
| SECONDARY Catheter Integrity Failure |
0; 0; 0 | — |
Summary
The purpose of this study is to compare multidetector computed tomography (CT) image quality following peripheral venous high pressure injection of iodinated intravenous contrast media between a 20 gauge (GA) fenestrated, intravenous catheter (BD Nexiva™ Diffusics™) and an 18 GA non-fenestrated, intravenous catheter.
In the contrast enhanced CT procedure (CECT), a machine (power injector) is used to rapidly deliver contrast agent to an individual's circulatory system. The contrast allows for greater differentiation of tissues in images of the area of interest, affording a better opportunity to visually assess the area and hence make a more accurate diagnosis.
CECT often requires a high rate of contrast flow (≥ 5 mL/sec) through the IV catheter to provide sufficient contrast for an acceptable image. Typically an 18 GA IV catheter is required to achieve these high flow rates; however, often the patient does not have a vein that will accommodate this large size catheter. The BD Nexiva™ Diffusics™ IV catheter is designed to deliver a higher flow rate than a conventional catheter of the same gauge by incorporating fenestrations (small openings) near the tip of the catheter that allow fluid to exit the catheter in addition to that which normally exits through the main opening at the tip of the catheter.
Eligibility Criteria
Inclusion Criteria
- Must be at least 18 years old at the time of enrollment,
- Must meet the investigational site's standard criteria for multi-detector Computed Tomography (CT),
- Per institutional protocol, the ordered scan must require a flow rate of 5.0-7.0 mL/sec (inclusive) for Visipaque 320 or 5.0-7.5 mL/sec (inclusive) for Omnipaque350 warmed to 35°C,
- The planned catheter insertion site must be located in the antecubital area,
- Must require any of the following multi-detector CT procedures: CT angiogram,CT pancreas,CT liver, CT kidney, Cardiac CT,
- Must be willing and able to provide informed consent,
- Must be able to read, write, and follow instructions in English,
- Must be able to accommodate a 20 G x 1.00 inch IV catheter,
Exclusion Criteria
- Preexisting IV catheter or contrast-compatible port in place suitable for power injection with the intent to be used for contrast enhanced CT,
- Subjects who have reported an adverse reaction that precludes use of iodine-based contrast media,
- Subjects who have had a prior extravasation event involving solutions considered irritants or vesicants.
Data sourced from ClinicalTrials.gov (NCT01772550). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.