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N/A N=61 Randomized Triple-blind Diagnostic

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

Contrast Enhanced Computed Tomography (CT) Scanning

Enrolled (actual)
61
Serious AEs
0.0%
Results posted
Feb 2018
Primary outcome: Primary: Image Quality as Assessed by Ratio of Tissue Density of Main Portal Vein (MPV) to the Aorta — 0.95; 0.95 Ratio

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Becton Dickinson Nexiva Diffusics System (Device); Standard intravenous catheter (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
The University of Texas Health Science Center, Houston
Primary completion
Nov 2016

Outcome Measures

OutcomeResultp-value
PRIMARY
Image Quality as Assessed by Ratio of Tissue Density of Main Portal Vein (MPV) to the Aorta
0.95; 0.95
PRIMARY
Image Quality as Assessed by Ratio of Tissue Density of Spleen to the Aorta
0.72; 0.69
PRIMARY
Image Quality as Assessed by Ratio of Tissue Density of Inferior Vena Cava (IVC) to the Aorta
0.52; 0.52
PRIMARY
Image Quality as Assessed by Rating Scale
8.5; 8.6 0.4487
SECONDARY
Peak Contrast Infusion Pressure
80; 93 0.0112 sig
SECONDARY
Injection Flow Rate
2.4; 2.3 0.0784

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.

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02943226). 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.

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