Effect of Three Side Hole Infusion Catheter on CT Image Quality Compared to a Standard Infusion Catheter

The University of Texas System (UT)

Status: Completed

Conditions: Contrast Enhanced Computed Tomography (CT) Scanning

Treatments: Device: Standard intravenous catheter; Device: Becton Dickinson Nexiva Diffusics System

Study type: Interventional

Funder types: Other

Identifiers

NCT02943226

HSC-MS15-0906

Details and patient eligibility

About

The purpose of this research study is to compare two types of catheters used for infusing the contrast dye necessary for viewing internal organs during computed tomography (CT) scanning. The standard catheter, which has one hole from which contrast dye enters veins, will be compared to the Becton Dickinson Nexiva Diffusics System catheter, which has three holes for diffusing dye into veins. The purpose of this study is to determine which catheter type gives the best image.

Full description

This will be a prospective, randomized, controlled trial. The catheter is already in use at our facilities. After informed consent, patients will be randomly given the standard or new catheter in our practice. Envelopes with the random assignment will be available to the individuals consenting patients. Randomization generally ensures that study groups are similar on average. As age, sex, and weight impact image quality, we will collect data on these factors in case randomization results in an imbalance. This will allow for control of these factors in analysis of the data. Data will be collected from CT abdomen pelvis examinations within a 6 month-1 year period in 2016 - 2017. Our primary outcome is image quality, measured as tissue density and distribution of contrast within the liver, spleen, aorta and IVC. Our secondary outcomes include Peak Contrast Infusion Pressure and Injection Flow Rate. Possible adverse events for use of any type of catheter include contrast infiltration into the subcutaneous tissues which is a minor limited event. All infiltrations will be recorded as part of the permanent medical record, documented in the chart, and the referring physician notified. The patient will be assessed by a physician immediately and referred to the ED if necessary for further evaluation. Current technology utilizes Power injector equipment which alerts the technologist to the pressure being achieved. If the injection pressure exceeds 325 psi the Power injector automatically shuts off.

Enrollment: 61 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients undergoing contrast enhanced CT abdomen pelvis examinations at Lyndon B. Johnson General Hospital in Texas
• Patients whose access point is the antecubital fossa
• Patients receiving 20 or 22 gauge catheters for their CT exam
• Patients scanned on two 64 slice CT scanners at the same hospital

Exclusion criteria

• patients whose access point is other than antecubital fossa

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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61 participants in 2 patient groups

Becton Dickinson Nexiva Diffusics System

Experimental group

Description:

Intervention with the new Becton Dickinson Nexiva Diffusics System will be evaluated to see if it will improve image quality compared to the standard catheter.

Treatment:

Device: Becton Dickinson Nexiva Diffusics System

Standard intravenous catheter

Active Comparator group

Description:

Standard catheter with one hole at the tip will be compared to novel 3 hole Becton Dickinson Nexiva Diffusics System to see which catheter provides the best image quality.

Treatment:

Device: Standard intravenous catheter