Trial Outcomes & Findings for Study of Effectiveness of Smaller Gauge Fenestrated Catheters for Use in IV Contrast Enhanced CT Scans (NCT NCT01772550)

NCT ID: NCT01772550

Last Updated: 2014-05-02

Results Overview

Study images were assessed by a US board-certified radiologist to determine whether the image is of acceptable quality. The radiologist was not informed of the study device used for the injection that produced the image under evaluation. Subjective image quality assessment for acceptability was determined by: * The report of the reading radiologist in the section of the report where the radiologist indicates if the image is acceptable or not. The absence of a comment in this section will be interpreted as acceptable, and, * the assessment of an independent single second reader (such as the subinvestigator or research radiologist) blinded to the reading radiologist's report and the infusion catheter type. In the case of a non-concurrence, the Principal Investigator assessed the image and his or her assessment had final authority.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 238 participants
• Primary outcome timeframe: at the time of image assessment
• Results posted on: 2014-05-02

Participant Flow

Subjects were recruited from those referred to the Johns Hopkins Outpatient Center for contrast enhanced computed tomography, or CECT. Subjects were recruited in January and February of 2013. The Overall Study table summarizes the number of subjects that Started and Completed in each Reporting Group, including the type of CECT procedure.

Subjects whose veins were determined to be unable to accommodate an 18 GA IV catheter, but that could accommodate a 20 GA IV catheter, were not randomized but were assigned to receive the 20 GA BD Nexiva™ Diffusics™ IV catheter (non-randomized cohort).

Participant milestones

Measure	20 GA BD Nexiva Diffusics - Randomized During their routinely scheduled CECT procedure, subjects receive IV contrast medium injected via the 20 GA fenestrated BD Nexiva Diffusics single port IV catheter	18 GA Conventional Catheter - Randomized During their routinely scheduled CECT procedure, subjects receive IV contrast medium injected via the non-fenestrated 18GA x 1.25 inch Smiths Medical Jelco IV catheter	20 GA BD Nexiva Diffusics - Nonrandomized Subjects whose veins are not suitable for an 18GA IV catheter will be assigned to this non-randomized arm. During their routinely scheduled CECT procedure, subjects receive IV contrast medium injected via the 20GA fenestrated BD Nexiva Diffusics single port IV catheter
Overall Study STARTED	102	103	33
Overall Study CT Pancreas	40	36	8
Overall Study CT Angiogram	24	25	4
Overall Study CT Liver	18	14	8
Overall Study CT Kidney	12	19	6
Overall Study CT Cardiac	7	7	1
Overall Study COMPLETED	101	102	27
Overall Study NOT COMPLETED	1	1	6

Reasons for withdrawal

Measure	20 GA BD Nexiva Diffusics - Randomized During their routinely scheduled CECT procedure, subjects receive IV contrast medium injected via the 20 GA fenestrated BD Nexiva Diffusics single port IV catheter	18 GA Conventional Catheter - Randomized During their routinely scheduled CECT procedure, subjects receive IV contrast medium injected via the non-fenestrated 18GA x 1.25 inch Smiths Medical Jelco IV catheter	20 GA BD Nexiva Diffusics - Nonrandomized Subjects whose veins are not suitable for an 18GA IV catheter will be assigned to this non-randomized arm. During their routinely scheduled CECT procedure, subjects receive IV contrast medium injected via the 20GA fenestrated BD Nexiva Diffusics single port IV catheter
Overall Study Unable to insert IV in antecubital vein	1	1	5
Overall Study Adverse Event	0	0	1

Baseline Characteristics

Study of Effectiveness of Smaller Gauge Fenestrated Catheters for Use in IV Contrast Enhanced CT Scans

Baseline characteristics by cohort

Measure	20 GA BD Nexiva Diffusics - Randomized n=102 Participants	18 GA Conventional Catheter - Randomized n=103 Participants	20 GA BD Nexiva Diffusics - Nonrandomized n=33 Participants	Total n=238 Participants Total of all reporting groups
Age, Continuous	61.6 years STANDARD_DEVIATION 12.9 • n=5 Participants	60.0 years STANDARD_DEVIATION 13.6 • n=7 Participants	58.8 years STANDARD_DEVIATION 12.3 • n=5 Participants	60.5 years STANDARD_DEVIATION 13.1 • n=4 Participants
Sex: Female, Male Female	45 Participants n=5 Participants	37 Participants n=7 Participants	20 Participants n=5 Participants	102 Participants n=4 Participants
Sex: Female, Male Male	57 Participants n=5 Participants	66 Participants n=7 Participants	13 Participants n=5 Participants	136 Participants n=4 Participants

PRIMARY outcome

Timeframe: at the time of image assessment

Population: One subject randomized to the 18 GA conventional catheter was excluded from the per-protocol analysis. Due to catheter placement, the required minimum flow rate of 5 mL/sec could not be achieved; contrast was administered at 4.5 mL/sec.

Study images were assessed by a US board-certified radiologist to determine whether the image is of acceptable quality. The radiologist was not informed of the study device used for the injection that produced the image under evaluation. Subjective image quality assessment for acceptability was determined by:

• The report of the reading radiologist in the section of the report where the radiologist indicates if the image is acceptable or not. The absence of a comment in this section will be interpreted as acceptable, and,
• the assessment of an independent single second reader (such as the subinvestigator or research radiologist) blinded to the reading radiologist's report and the infusion catheter type.

In the case of a non-concurrence, the Principal Investigator assessed the image and his or her assessment had final authority.

Outcome measures

Measure	20 GA BD Nexiva Diffusics - Randomized n=101 Participants	18 GA Conventional Catheter - Randomized n=101 Participants	20 GA BD Nexiva Diffusics - Nonrandomized n=27 Participants
Acceptable Image Quality	100 percentage of participants	100 percentage of participants	100 percentage of participants

SECONDARY outcome

Timeframe: at the time of image assessment

Population: 126 subjects had HU measurements available from abdominal CT imaging.

Objective image quality assessment was performed by a board-certified Research Radiologist, by measuring the post-contrast aortic attenuation in Hounsfield Units (HU) at either the aortic arch if chest is imaged or the diaphragmatic crus and above the aortic bifurcation or on the most inferior image on the arterial phase. Hounsfield units within the proximal and distal aorta were recorded for each subject image reviewed. The average number of HU for each group in the Study are reported descriptively; formal acceptance criteria for this objective are not specified.

Outcome measures

Measure	20 GA BD Nexiva Diffusics - Randomized n=63 Participants	18 GA Conventional Catheter - Randomized n=63 Participants	20 GA BD Nexiva Diffusics - Nonrandomized
Abdomen CT - Average Hounsfield Units as a Measure of Aortic Contrast Delivery and Enhancement in Randomized Subjects	400.9 Hounsfield Units Standard Deviation 69.8	402.5 Hounsfield Units Standard Deviation 91.5	—

SECONDARY outcome

Timeframe: at the time of image assessment

Population: 20 subjects had HU measurements available from thoracic CT imaging.

Objective image quality assessment was performed by a board-certified Research Radiologist, by measuring the post-contrast aortic attenuation in Hounsfield Units (HU) at either the aortic arch if chest is imaged or the diaphragmatic crus and above the aortic bifurcation or on the most inferior image on the arterial phase. Hounsfield units within the proximal and distal aorta were recorded for each subject image reviewed. The average number of HU for each group in the Study are reported descriptively; formal acceptance criteria for this objective are not specified.

Outcome measures

Measure	20 GA BD Nexiva Diffusics - Randomized n=10 Participants	18 GA Conventional Catheter - Randomized n=10 Participants	20 GA BD Nexiva Diffusics - Nonrandomized
Chest CT - Average Hounsfield Units as a Measure of Aortic Contrast Delivery and Enhancement in Subjects Whose Veins Could Accommodate an 18 GA IV Catheter (Randomized Subjects)	428.9 Hounsfield Units Standard Deviation 76.9	402.2 Hounsfield Units Standard Deviation 87.2	—

SECONDARY outcome

Timeframe: at the time of image assessment

Population: 54 subjects had HU measurements available from complete chest and abdomen CT imaging.

Objective image quality assessment was performed by a board-certified Research Radiologist, by measuring the post-contrast aortic attenuation in Hounsfield Units (HU) at either the aortic arch if chest is imaged or the diaphragmatic crus and above the aortic bifurcation or on the most inferior image on the arterial phase. Hounsfield units within the proximal and distal aorta were recorded for each subject image reviewed. The average number of HU for each group in the Study are reported descriptively; formal acceptance criteria for this objective are not specified.

Outcome measures

Measure	20 GA BD Nexiva Diffusics - Randomized n=27 Participants	18 GA Conventional Catheter - Randomized n=27 Participants	20 GA BD Nexiva Diffusics - Nonrandomized
Complete Chest and Abdomen CT - Average Hounsfield Units as a Measure of Aortic Contrast Delivery and Enhancement in Subjects Whose Veins Could Accommodate an 18 GA IV Catheter (Randomized Subjects)	373.2 Hounsfield Units Standard Deviation 68.9	387.7 Hounsfield Units Standard Deviation 71.7	—

SECONDARY outcome

Timeframe: immediately after power injection

Population: One subject randomized to the 18 GA conventional IV was excluded from the analysis as the required minimum flow rate could not be achieved due to IV placement. Non-randomized flow rate analysis only includes subjects who completed successful contrast delivery; one subject with extravasation upon delivery was discontinued and is not included.

Maximum flow rate guidelines provided in the BD Nexiva Diffusics Instructions for Use were to be followed. The maximum flow rate (milliliters per second, or mL/sec) utilized was recorded by the Radiology Technician immediately following the power injection of iodinated intravenous contrast media. Results are descriptively summarized; no formal acceptance criteria were specified by the protocol.

Outcome measures

Measure	20 GA BD Nexiva Diffusics - Randomized n=101 Participants	18 GA Conventional Catheter - Randomized n=101 Participants	20 GA BD Nexiva Diffusics - Nonrandomized n=27 Participants
Maximum Flow Rate	5.58 mL/second Standard Deviation 0.49	5.74 mL/second Standard Deviation 0.66	5.46 mL/second Standard Deviation 0.44

SECONDARY outcome

Timeframe: immediately after catheter insertion

Population: All subjects for whom an insertion was attempted are included in the analysis for insertion success. This includes some subjects that did not go on to complete the study.

Insertion is successful when the catheter can be flushed or infused to demonstrate patency, and there is no inadvertent administration of a solution or medication into the tissue surrounding the IV catheter.

The number of participants with successfully inserted catheters after the first or second insertion attempt is reported. The clinician inserting the IV catheter made a clinical judgement as to whether the catheter was successfully placed; the protocol did not define more specific criteria. Catheter insertion success rates were determined from each IV insertion attempted in the Study.

Outcome measures

Measure	20 GA BD Nexiva Diffusics - Randomized n=102 Participants	18 GA Conventional Catheter - Randomized n=103 Participants	20 GA BD Nexiva Diffusics - Nonrandomized n=33 Participants
Catheter Insertion Success Success with first insertion attempt	96 participants	100 participants	20 participants
Catheter Insertion Success Success with second attempt	5 participants	2 participants	8 participants
Catheter Insertion Success Unsuccessful after second attempt	1 participants	1 participants	5 participants

SECONDARY outcome

Timeframe: upon contrast injection

Population: One subject randomized to the 18 GA IV was excluded from the per-protocol analysis as minimum flow rate could not be achieved. Non-randomized group analysis includes 1 subject with media extravasation with first study IV (adverse event). Subject was discontinued and not included in primary outcomes analysis.

The number of subjects who experienced injections with extravasation of contrast media is reported.

Outcome measures

Measure	20 GA BD Nexiva Diffusics - Randomized n=101 Participants	18 GA Conventional Catheter - Randomized n=101 Participants	20 GA BD Nexiva Diffusics - Nonrandomized n=28 Participants
Extravasation of Contrast Media	0 participants	0 participants	1 participants

SECONDARY outcome

Timeframe: immediately after contrast injection

Population: One subject randomized to the 18 GA conventional IV was excluded from the analysis as the required minimum flow rate could not be achieved due to IV placement. Non-randomized group analysis includes 1 subject with media extravasation with first study IV (adverse event). Subject was discontinued and not included in primary outcomes analysis.

The number of subjects who experienced injections with automatic injection shutoff is reported. Immediately after the power injection, the injection technician recorded whether or not an automatic injection shutoff occurred.

Outcome measures

Measure	20 GA BD Nexiva Diffusics - Randomized n=101 Participants	18 GA Conventional Catheter - Randomized n=101 Participants	20 GA BD Nexiva Diffusics - Nonrandomized n=28 Participants
Automatic Injection Shutoff	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: immediately after contrast injection

Population: One subject randomized to the 18 GA conventional IV was excluded from the analysis as the required minimum flow rate could not be achieved due to IV placement. Non-randomized group analysis includes 1 subject with media extravasation with first study IV (adverse event). Subject was discontinued and not included in primary outcomes analysis.

The number of subjects who experienced injections with activation of the high pressure alarm is reported. Immediately following the power injection, the clinician performing the power injection recorded whether or not the high pressure alarm sounded.

Outcome measures

Measure	20 GA BD Nexiva Diffusics - Randomized n=101 Participants	18 GA Conventional Catheter - Randomized n=101 Participants	20 GA BD Nexiva Diffusics - Nonrandomized n=28 Participants
High Pressure Alarm	0 participants	1 participants	1 participants

SECONDARY outcome

Timeframe: Immediately following power injection

Population: One subject randomized to the 18 GA conventional IV was excluded from the analysis as the required minimum flow rate could not be achieved due to IV placement. Non-randomized group analysis includes 1 subject with media extravasation with first study IV (adverse event). Subject was discontinued and not included in primary outcomes analysis.

The number of subjects who experienced partial or complete dislodgement of the catheter from the subject prior to power injection procedure completion is reported. The information about the IV catheter was collected by a clinically qualified study staff member (e.g., the Principal or sub-Investigator, or Study Coordinator) after the power injection.

Outcome measures

Measure	20 GA BD Nexiva Diffusics - Randomized n=101 Participants	18 GA Conventional Catheter - Randomized n=101 Participants	20 GA BD Nexiva Diffusics - Nonrandomized n=28 Participants
Catheter Dislodgement	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: immediately after power injection

Population: One subject randomized to the 18 GA conventional IV was excluded from the analysis as the required minimum flow rate could not be achieved due to IV placement. Non-randomized group analysis includes 1 subject with media extravasation with first study IV (adverse event). Subject was discontinued and not included in primary outcomes analysis.

The number of subjects who experienced catheter transfixation (the IV penetrating the opposite wall of the vein) is reported. This information was collected by a clinically qualified study staff member (e.g., the Principal or sub-Investigator, or Study Coordinator) after the power injection.

Outcome measures

Measure	20 GA BD Nexiva Diffusics - Randomized n=101 Participants	18 GA Conventional Catheter - Randomized n=101 Participants	20 GA BD Nexiva Diffusics - Nonrandomized n=28 Participants
Catheter Transfixation	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: immediately after power injection

Population: One subject randomized to the 18 GA conventional IV was excluded from the analysis as the required minimum flow rate could not be achieved due to IV placement. Non-randomized group analysis includes 1 subject with media extravasation with first study IV (adverse event). Subject was discontinued and not included in primary outcomes analysis.

Catheter integrity failure generally refers to any portion of the device breaking or malfunctioning so that its proper function is no longer assured. In this study, the most relevant catheter integrity failures to be assessed were fluid leakage, tubing rupture, or tubing separation from the hub.

The number of subjects who experienced injections with a catheter integrity failure during injection is reported. The information about the IV catheter was collected by a clinically qualified study staff member (e.g., the Principal or sub-Investigator, or Study Coordinator) after the power injection.

Outcome measures

Measure	20 GA BD Nexiva Diffusics - Randomized n=101 Participants	18 GA Conventional Catheter - Randomized n=101 Participants	20 GA BD Nexiva Diffusics - Nonrandomized n=28 Participants
Catheter Integrity Failure	0 participants	0 participants	0 participants

Adverse Events

20 GA BD Nexiva Diffusics - Randomized

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

18 GA Conventional Catheter - Randomized

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

20 GA BD Nexiva Diffusics - Nonrandomized

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	20 GA BD Nexiva Diffusics - Randomized n=102 participants at risk	18 GA Conventional Catheter - Randomized n=103 participants at risk	20 GA BD Nexiva Diffusics - Nonrandomized n=33 participants at risk
Vascular disorders Extravasation	0.00% 0/102	0.00% 0/103	3.0% 1/33 • Number of events 1

Additional Information

Randall Jones, MD

Becton, Dickinson and Company

Phone: 801 565-2843

Email: randall_jones@bd.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60