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Study of Effectiveness of Smaller Gauge Fenestrated Catheters for Use in IV Contrast Enhanced CT Scans (ARCTR05)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Becton, Dickinson and Company
ClinicalTrials.gov Identifier:
NCT01772550
First received: January 17, 2013
Last updated: March 5, 2013
Last verified: March 2013
History of Changes
  Purpose

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 (G) fenestrated, intravenous catheter (BD Nexiva™ Diffusics™) and an 18 G 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 gauge (G) 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.


Condition Intervention
Contrast Enhanced Computed Tomography
 Device: 20G BD Nexiva Diffusics
Device: 18G Conventional Catheter

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Randomized Controlled Study to Determine Whether Smaller Gauge Fenestrated Catheters Are as Effective as Larger Gauge Non-fenestrated Catheters for Use in IV Contrast Enhanced CT Scans

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Becton, Dickinson and Company:

Primary Outcome Measures:
  • Acceptable Image Quality [ Time Frame: upon image assessment ] [ Designated as safety issue: No ]

    Study images will be assessed by a US board-certified radiologist to determine whether the image is of acceptable quality. The radiologist will not be informed of the study device used for the injection that produced the image under evaluation.

    Subjective image quality assessment for acceptability will be determined by

    • The report of the reading radiologist in the section of the report where the radiologist indicates if the image is acceptable or not. The absence of a comment in this section will be interpreted as acceptable, and,
    • the assessment of an independent single second reader (such as the subinvestigator or research radiologist) blinded to the reading radiologist's report and the infusion catheter type.

    In the case of a non-concurrence, the Principal Investigator will assess the image and his or her assessment will have final authority.



Secondary Outcome Measures:
  • Aortic contrast delivery and enhancement [ Time Frame: upon image assessment ] [ Designated as safety issue: No ]
    Objective CECT image quality assessment for contrast delivery and enhancement level will be performed by a US board-certified radiologist, by measuring the post-contrast aortic attenuation (Hounsfield Units, HU). Hounsfield Units will be determined within the most cephalad aortic segment imaged (arch for thoracic, diaphragmatic crus for abdominal) and/or the most caudal segment imaged (i.e., the aortic bifurcation). The radiologist will not be informed of the study device used for the injection that produced the image under evaluation.

  • Maximum Flow Rate [ Time Frame: upon contrast injection ] [ Designated as safety issue: No ]

    The maximum flow rate will be recorded by the Radiology Technician immediately following the power injection of iodinated intravenous contrast media.

    Maximum flow rate for 20 G BD Nexiva™ Diffusics™ IV catheters and conventional 18 G IV catheters will be compared based on the difference in average maximum flow rates.


  • Catheter Insertion Success Rate [ Time Frame: upon catheter insertion ] [ Designated as safety issue: No ]
    Catheter insertion success rates will be calculated from each IV insertion attempted in the Study. Statistical significance of comparisons between 20 G BD Nexiva™ Diffusics™ IV catheters and conventional 18 G IV catheters in subjects whose veins can accommodate an 18 G IV catheter will be examined and reported descriptively.

  • Extravasation [ Time Frame: upon contrast injection ] [ Designated as safety issue: Yes ]
    The percentage of injections with extravasation will be calculated for the 20 G BD Nexiva™ Diffusics™ IV catheters and conventional 18 G IV catheters

  • Automatic Injection Shutoff or Alarm [ Time Frame: upon contrast injection ] [ Designated as safety issue: Yes ]
    The percentage of injections with automatic injection shutoff or high pressure alarm during injection will be calculated for the 20 G BD Nexiva™ Diffusics™ IV catheters and conventional 18 G IV catheters

  • Catheter dislodgement [ Time Frame: From catheter insertion to completion of the procedure ] [ Designated as safety issue: Yes ]
    Partial or complete dislodgement of the catheter from the subject prior to procedure completion will be recorded. The percentage of injections with catheter dislodgement will be calculated for the 20 G BD Nexiva™ Diffusics™ IV catheters and conventional 18 G IV catheters.

  • Catheter transfixation [ Time Frame: from catheter insertion until removal ] [ Designated as safety issue: Yes ]
    The frequency of catheter transfixation (penetrating the opposite wall of the vein) will be calculated for the 20 G BD Nexiva™ Diffusics™ IV catheters and conventional 18 G IV catheters.

  • Catheter failure [ Time Frame: during injection ] [ Designated as safety issue: Yes ]
    The frequency of catheter failure (e.g., integrity failure) during injection will be calculated for the 20 G BD Nexiva™ Diffusics™ IV catheters and conventional 18 G IV catheters.

  • Composite outcome [ Time Frame: from catheter insertion to removal ] [ Designated as safety issue: Yes ]

    A composite of these events will be created to capture all events into one response:

    • Extravasation
    • Automatic injector shutoff or high pressure alarm during injection
    • Catheter integrity failure during injection
    • Catheter dislodgment
    • Transfixation

    For each injection, this composite will be coded as "yes" for any of the events listed above and "no" if none of the events were observed. Statistically significant differences between the control and evaluation catheters, among subjects whose veins can accommodate an 18 G IV catheter, will be determined with a Score test for the difference of percentages of the composite response.



Enrollment: 238
Study Start Date: January 2013
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 20 Gauge BD Nexiva Diffusics
During their routinely scheduled contrast-enhanced computed tomography procedure, subjects in this arm will receive IV contrast media injected via the fenestrated 20G x 1.00inch BD Nexiva™ Diffusics™ single port IV catheter.
 Device: 20G BD Nexiva Diffusics

The Inserter will have a single attempt on each arm (antecubital area) in which to insert the study catheter. If the catheter is not successfully inserted on the first attempt, the Inserter may make a second attempt in the contralateral arm.

If the Inserter is unsuccessful in the second attempt, the subject is to be discontinued from the Study, and additional (non-Study) insertion attempts may be made according to facility policies.

Other Name: 20G x 1 inch BD Nexiva™ Diffusics™ IV catheter (#383592)
Active Comparator: 18 Gauge Conventional Catheter
During their routinely scheduled contrast-enhanced computed tomography procedure, subjects in this arm will receive IV contrast media injected via the non-fenestrated 18G x 1.25 inch Smiths Medical Jelco® IV Catheter.
 Device: 18G Conventional Catheter

The Inserter will have a single attempt on each arm (antecubital area) in which to insert the study catheter. If the catheter is not successfully inserted on the first attempt, the Inserter may make a second attempt in the contralateral arm.

If after the first attempt, there is no vein in the contralateral arm that can accommodate an 18 gauge catheter, the subject is to be discontinued from the Study, and additional (non-Study) insertion attempts may be made according to facility policies.

Other Name: 18G x 1.25 inch Smiths Medical Jelco® IV Catheter (cat#4055)

Detailed Description:

This is a prospective study performed in adult human subjects who have been referred for a CECT. The study will occur during a single visit. Once consented and enrolled, subjects whose antecubital veins can accommodate an 18 gauge (G) IV catheter (as assessed by the Inserter or designee of the PI), will be randomized to receive either a conventional 18 G IV catheter (reference, control) or a 20 G BD Nexiva™ Diffusics™ IV catheter (test). Subjects whose veins are not considered suitable for an 18 G IV catheter will be placed in a non-randomized cohort for placement of a 20 G BD Nexiva™ Diffusics™ IV catheter. Subjects will receive one (1) catheter for the study.

The primary objective 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 G fenestrated, intravenous catheter (BD Nexiva™ Diffusics™) and an 18 G non-fenestrated, intravenous catheter. The 20 G BD Nexiva™ Diffusics™ IV catheter will be considered non-inferior to conventional 18 G IV catheters if the 95% upper bound for the difference in percentage of images of acceptable quality between the images acquired using the 18 G IV catheters and the 20 G BD Nexiva™ Diffusics™ IV catheters is less than 15%.

Study catheters will be inserted by appropriately licensed healthcare professionals (Inserters). Prior to enrollment, potential Inserters will be trained and qualified by the Sponsor on proper use of the BD Nexiva™ Diffusics™ IV catheter in both an artificial hand model and then in human patients. Inserters will then be expected to use the test product for a period of two (2) weeks, in order to gain familiarity with the product. Because BD Nexiva™ Diffusics™ IV catheters are not currently used in the Johns Hopkins Outpatient Center, the Sponsor will provide BD Nexiva™ Diffusics™ IV catheters for use during this training and familiarization period.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01772550

Locations
United States, Maryland
Johns Hopkins Outpatient Center
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Becton, Dickinson and Company
Investigators
Principal Investigator: Elliot Fishman, MD Johns Hopkins University
  More Information

No publications provided

Responsible Party: Becton, Dickinson and Company
ClinicalTrials.gov Identifier: NCT01772550     History of Changes
Other Study ID Numbers: INF-11-ARCTR05
Study First Received: January 17, 2013
Last Updated: March 5, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Becton, Dickinson and Company:
CECT, catheter, contrast

ClinicalTrials.gov processed this record on June 17, 2013