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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2016-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Imaging Techniques in CT: Technical Development

NCT02242448

Healthy Volunteers

TERMINATED

Thoracoabdominal Arortic CTA Study

NCT02291718

Thoracic Aortic Aneurysm

COMPLETED PHASE4

Catheter Tip Position and Contrast Distribution Following Paravertebral Catheter Insertion: a CT Study

NCT07064317

Breast Cancer Patients

COMPLETED

Use of Electrical Impedence to Measure Lean Body Weight as a Determinant of the Dose of Contrast Media for Abdominal CT

NCT02170688

IV Contrast Dosing

COMPLETED PHASE4

Coronary Computed Tomography (CT) Angiography Versus Standard Therapy in the Emergency Room

NCT00846469

Chest Pain

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Contrast Enhanced Computed Tomography (CT) Scanning

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Becton Dickinson Nexiva Diffusics System

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.

Group Type EXPERIMENTAL

Becton Dickinson Nexiva Diffusics System

Intervention Type DEVICE

Becton Dickinson Nexiva Diffusics System will be used to inject IV contrast and will be compared to a single hole catheter to see if it improves image quality in the main vessels in the abdomen and pelvis because of its novel design.

Standard intravenous catheter

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.

Group Type ACTIVE_COMPARATOR

Standard intravenous catheter

Intervention Type DEVICE

Standard catheter with one hole at the tip will be compared to a novel 3 hole catheter to see which catheter provides the best image quality.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Becton Dickinson Nexiva Diffusics System

Becton Dickinson Nexiva Diffusics System will be used to inject IV contrast and will be compared to a single hole catheter to see if it improves image quality in the main vessels in the abdomen and pelvis because of its novel design.

Intervention Type DEVICE

Standard intravenous catheter

Standard catheter with one hole at the tip will be compared to a novel 3 hole catheter to see which catheter provides the best image quality.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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