Trial Outcomes & Findings for Effect of Three Side Hole Infusion Catheter on CT Image Quality Compared to a Standard Infusion Catheter (NCT NCT02943226)

NCT ID: NCT02943226

Last Updated: 2018-06-06

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

61 participants

Primary outcome timeframe

at the time of CT scanning

Results posted on

2018-06-06

Participant Flow

Participant milestones

Participant milestones
Measure	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.	Standard Intravenous Non-fenestrated Catheter The standard catheter has one hole at the tip for contrast infusion.
Overall Study STARTED	31	30
Overall Study COMPLETED	31	30
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Becton Dickinson Nexiva Diffusics System Fenestrated Catheter n=31 Participants 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.	Standard Intravenous Non-fenestrated Catheter n=30 Participants The standard catheter has one hole at the tip for contrast infusion.	Total n=61 Participants Total of all reporting groups
Sex: Female, Male Female	16 Participants n=31 Participants	17 Participants n=30 Participants	33 Participants n=61 Participants
Sex: Female, Male Male	15 Participants n=31 Participants	13 Participants n=30 Participants	28 Participants n=61 Participants
Age, Continuous	50.8 years STANDARD_DEVIATION 11.2 • n=31 Participants	52.9 years STANDARD_DEVIATION 13.8 • n=30 Participants	51.9 years STANDARD_DEVIATION 12.5 • n=61 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	31 participants n=31 Participants	30 participants n=30 Participants	61 participants n=61 Participants
Abdominal anterioposterior diameter at lower kidneys	27.0 centimeters STANDARD_DEVIATION 5.1 • n=31 Participants	26.6 centimeters STANDARD_DEVIATION 4.4 • n=30 Participants	26.8 centimeters STANDARD_DEVIATION 4.7 • n=61 Participants
Abdominal transverse (left-right) diameter at lower kidneys	38.7 centimeters STANDARD_DEVIATION 7.9 • n=29 Participants • Abdominal transverse (left-right) diameter at lower kidney data was not collected for all subjects.	37.0 centimeters STANDARD_DEVIATION 5.7 • n=29 Participants • Abdominal transverse (left-right) diameter at lower kidney data was not collected for all subjects.	37.1 centimeters STANDARD_DEVIATION 6.1 • n=58 Participants • Abdominal transverse (left-right) diameter at lower kidney data was not collected for all subjects.

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Becton Dickinson Nexiva Diffusics System Fenestrated Catheter n=31 Participants 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.	Standard Intravenous Non-fenestrated Catheter n=30 Participants The standard catheter has one hole at the tip for contrast infusion.
Image Quality as Assessed by Ratio of Tissue Density of Main Portal Vein (MPV) to the Aorta	0.95 Ratio Standard Deviation 0.18	0.95 Ratio Standard Deviation 0.18

PRIMARY outcome

Timeframe: at the time of CT scanning

Population: Data for the "Becton Dickinson Nexiva Diffusics System fenestrated catheter" arm was not collected for one patient because the patient had a splenectomy.

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.

Outcome measures

Outcome measures
Measure	Becton Dickinson Nexiva Diffusics System Fenestrated Catheter n=30 Participants 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.	Standard Intravenous Non-fenestrated Catheter n=30 Participants The standard catheter has one hole at the tip for contrast infusion.
Image Quality as Assessed by Ratio of Tissue Density of Spleen to the Aorta	0.72 Ratio Standard Deviation 0.12	0.69 Ratio Standard Deviation 0.12

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Becton Dickinson Nexiva Diffusics System Fenestrated Catheter n=31 Participants 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.	Standard Intravenous Non-fenestrated Catheter n=30 Participants The standard catheter has one hole at the tip for contrast infusion.
Image Quality as Assessed by Ratio of Tissue Density of Inferior Vena Cava (IVC) to the Aorta	0.52 Ratio Standard Deviation 0.15	0.52 Ratio Standard Deviation 0.18

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Becton Dickinson Nexiva Diffusics System Fenestrated Catheter n=31 Participants 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.	Standard Intravenous Non-fenestrated Catheter n=30 Participants The standard catheter has one hole at the tip for contrast infusion.
Image Quality as Assessed by Rating Scale	8.5 units on a scale Standard Deviation 0.97	8.6 units on a scale Standard Deviation 0.87

SECONDARY outcome

Timeframe: at the time of CT scanning

Population: Peak contrast infusion pressure data was not collected by the technologist for one patient in the "Standard intravenous non-fenestrated catheter" arm.

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.

Outcome measures

Outcome measures
Measure	Becton Dickinson Nexiva Diffusics System Fenestrated Catheter n=31 Participants 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.	Standard Intravenous Non-fenestrated Catheter n=29 Participants The standard catheter has one hole at the tip for contrast infusion.
Peak Contrast Infusion Pressure	80 Pounds per square inch (PSI) Interval 71.0 to 89.0	93 Pounds per square inch (PSI) Interval 81.0 to 114.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Becton Dickinson Nexiva Diffusics System Fenestrated Catheter n=31 Participants 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.	Standard Intravenous Non-fenestrated Catheter n=30 Participants The standard catheter has one hole at the tip for contrast infusion.
Injection Flow Rate	2.4 milliliters per second (mL/sec) Standard Deviation 0.4	2.3 milliliters per second (mL/sec) Standard Deviation 0.3

Adverse Events

Becton Dickinson Nexiva Diffusics System Fenestrated Catheter

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard Intravenous Non-fenestrated Catheter

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Joseph P. Hasapes, M.D.

The University of Texas Health Science Center at Houston

Phone: (713) 566-5440

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place