Clinical trial NCT02943226: Effect of Three Side Hole Infusion Catheter on CT Image Quality Compared to a Standard Infusion Catheter
Official title: IV Contrast Administration: Effect of Three Side Hole Infusion Catheter on CT Image Quality, Infusion Pressure, and Infusion Rates, Compared to a Standard Infusion Catheter
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contrast Enhanced Computed Tomography (CT) Scanning
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2016-10-24
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Image Quality as Assessed by Ratio of Tissue Density of Main Portal Vein (MPV) to the Aorta
timeFrame: at the time of CT scanning
measure: Image Quality as Assessed by Ratio of Tissue Density of Spleen to the Aorta
timeFrame: at the time of CT scanning
measure: Image Quality as Assessed by Ratio of Tissue Density of Inferior Vena Cava (IVC) to the Aorta
timeFrame: at the time of CT scanning
measure: Image Quality as Assessed by Rating Scale
timeFrame: at the time of CT scanning
Secondary outcomes:
measure: Peak Contrast Infusion Pressure
timeFrame: at the time of CT scanning
measure: Injection Flow Rate
timeFrame: at the time of CT scanning
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Joseph Hasapes, MD
role: PRINCIPAL_INVESTIGATOR
References: