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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02943226

Enrollment

Registered

2016-10-24

Start date

2016-10-31

Completion date

2016-11-30

Last updated

2018-06-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Contrast Enhanced Computed Tomography (CT) Scanning

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.

Interventions

DEVICEBecton 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.

DEVICEStandard 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Image Quality as Assessed by Ratio of Tissue Density of Main Portal Vein (MPV) to the Aorta	at the time of CT scanning	The ratio of tissue density measured in the main portal vein (MPV) to tissue density in the aorta on the CT images will be determined and will provide a measure of biodistribution, which is an important indicator of image quality. Dividing each Hounsfield unit measurement by the aorta density and determining these ratios will be done on a per patient basis to assess biodistribution as a measure of image quality.
Image Quality as Assessed by Ratio of Tissue Density of Spleen to the Aorta	at the time of CT scanning	The ratio of tissue density measured in the spleen to tissue density in the aorta on the CT images will be determined and will provide a measure of biodistribution, which is an important indicator of image quality. Dividing each Hounsfield unit measurement by the aorta density and determining these ratios will be done on a per patient basis to assess biodistribution as a measure of image quality.
Image Quality as Assessed by Ratio of Tissue Density of Inferior Vena Cava (IVC) to the Aorta	at the time of CT scanning	The ratio of tissue density measured in the inferior vena cava (IVC) to tissue density in the aorta on the CT images will be determined and will provide a measure of biodistribution, which is an important indicator of image quality. Dividing each Hounsfield unit measurement by the aorta density and determining these ratios will be done on a per patient basis to assess biodistribution as a measure of image quality.
Image Quality as Assessed by Rating Scale	at the time of CT scanning	Radiologists blinded to catheter type will review images and rate them on a scale of 1 to 10. 10 indicates a better outcome.

Secondary

Measure	Time frame	Description
Peak Contrast Infusion Pressure	at the time of CT scanning	The peak contrast infusion pressure is recorded in the electronic health record (EHR) during every CT examination preformed at the hospitals taking part in this study.
Injection Flow Rate	at the time of CT scanning	The injection flow rate is recorded in the electronic health record (EHR) during every CT examination preformed at the hospitals taking part in this study.

Countries

United States

Participant flow

Participants by arm

Arm	Count
Becton Dickinson Nexiva Diffusics System Fenestrated Catheter Becton Dickinson (BD) Nexiva™ Diffusics™ System uses three laser-cut tear-drop holes located in the catheter tip to stabilize the catheter tip by reducing flow velocities while maintaining flow rates during intravenous contrast administration into the vein.	31
Standard Intravenous Non-fenestrated Catheter The standard catheter has one hole at the tip for contrast infusion.	30
Total	61

Baseline characteristics

Characteristic	Total	Standard Intravenous Non-fenestrated Catheter	Becton Dickinson Nexiva Diffusics System Fenestrated Catheter
Abdominal anterioposterior diameter at lower kidneys	26.8 centimeters STANDARD_DEVIATION 4.7	26.6 centimeters STANDARD_DEVIATION 4.4	27.0 centimeters STANDARD_DEVIATION 5.1
Abdominal transverse (left-right) diameter at lower kidneys	37.1 centimeters STANDARD_DEVIATION 6.1	37.0 centimeters STANDARD_DEVIATION 5.7	38.7 centimeters STANDARD_DEVIATION 7.9
Age, Continuous	51.9 years STANDARD_DEVIATION 12.5	52.9 years STANDARD_DEVIATION 13.8	50.8 years STANDARD_DEVIATION 11.2
Race and Ethnicity Not Collected	0 Participants	—	—
Region of Enrollment United States	61 participants	30 participants	31 participants
Sex: Female, Male Female	33 Participants	17 Participants	16 Participants
Sex: Female, Male Male	28 Participants	13 Participants	15 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 31	0 / 30
other Total, other adverse events	0 / 31	0 / 30
serious Total, serious adverse events	0 / 31	0 / 30

Outcome results

Primary

Image Quality as Assessed by Rating Scale

Radiologists blinded to catheter type will review images and rate them on a scale of 1 to 10. 10 indicates a better outcome.