Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000328673
Ethics application status
Approved
Date submitted
9/03/2023
Date registered
28/03/2023
Date last updated
28/03/2023
Date data sharing statement initially provided
28/03/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Impact of Catheter Stabilization on Catheter Micro-Motion and Function
Scientific title
Impact of Catheter Stabilization on Catheter Micro-Motion and Function in a Healthy Population.
Secondary ID [1] 308784 0
Nil known
Universal Trial Number (UTN)
U1111-1289-5690
Trial acronym
MOTION
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Phlebitis 329286 0
Thrombosis 329287 0
Condition category
Condition code
Cardiovascular 326239 326239 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BRIEF NAME
Participants will have a clinically approved vascular catheter (Introcan Safety 3) inserted into the cephalic vein of either the left or right lower arm under ultrasound guidance for a period of up to 72 hours.

The Introcan Safety 3 device contains a multi-access blood control septum to help prevent blood leakage and exposure during catheter insertion and while connecting/disconnecting Luer devices. This device also has an integrated stabilisation platform, in the design of two wings (one wing on each side of the catheter hub) to allow for greater surface area contact with the skin. This greater surface area contact allows for increased anchorage capabilities to the skin surface, therefore increasing the stabilisation of the entire device. The comparator/control device does not have either of these design elements.

WHY
The purpose of this study is to accurately assess whether catheter micro-motion affects thrombosis and catheter failure in humans, as failure rates of vascular catheters are currently affecting up to 69% of patients in a clinical setting (i.e., hospital). The interventional arm includes the use of a vascular catheter with additional design elements that help to secure and prevent catheter movement as compared to the control arm.

WHAT
Materials:
Participants recruited into the study will be consented using a participant informed consent form (PICF) delivered by the principal- or sub-investigator. Participants will also be provided with home instructions detailing lifestyle, medication, dietary restrictions, catheter care instructions, and safety instructions (including where to go and who to contact in the event of an adverse event of emergent situation). The funding body B. Braun Group (who is providing the vascular catheters used in this study) have provided device use and care training to all members of the study team within 12 weeks of recruitment of the first participant (completed 19/JAN/2023). The study team have also provided a study synopsis and training to all individuals involved. All individuals have completed Good Clinical Practice (GCP) training.

Procedure:
The vascular catheter location, will be assessed repeatedly over 72 hours using two- and three-dimensional ultrasound, as will assessment of vascular catheter patency and adverse events/failure mechanisms including thrombus formation and phlebitis. At the end of the trial participants will evaluate the benefits and preferences of the two devices tested through the completion of a participant experience survey.

WHO:
The devices will be inserted by a trained phlebotomist under ultrasound with a minimum of 5 years' experience. The devices will be assessed and imaged using ultrasound by a trained individual of over 2 years' experience. The vascular catheters will be flushed, and the insertion sites assessed, twice daily (AM and PM) by registered nurses.

HOW:
The interventional device (Introcan Safety 3) will be inserted individually in a face-to-face setting, with insertion of the interventional device taking up to 30 minutes.

WHERE:
The clinical trial will be undertaken at the Clinical Trials Unit (CTU), Building G40 at the Griffith University Gold Coast campus, Queensland Australia.

WHEN and HOW MUCH:
The study intervention will be delivered once to each participant, on the first interventional day. At each defined timepoint (up to 14 per participant), the sub-investigator will perform ultrasound assessment and imaging of the vascular catheter distal to the insertion site to image the catheter tip and its motion in the vessel. These images will then be used in data analysis.
Intervention code [1] 325619 0
Treatment: Devices
Comparator / control treatment
BRIEF NAME/DESCRIPTION:
Participants will have a clinically approved vascular catheter (Introcan Safety) inserted into the cephalic vein of either the left or right lower arm for a period of up to 72 hours.

Note: This is a different device (earlier model) to the interventional study device (Introcan Safety 3).

WHY
The purpose of this study is to accurately assess whether catheter micro-motion affects thrombosis and catheter failure in humans, as failure rates of vascular catheters are currently affecting up to 69% of patients in a clinical setting (i.e., hospital).

Note: the control arm differs from that of the interventional arm as there are no additional design elements intended to secure and prevent catheter movement as seen in the interventional arm.

WHAT
Materials:
Participants recruited into the study will be consented using a participant informed consent form (PICF) delivered by the principal- or sub-investigator. Participants will also be provided with home instructions detailing lifestyle, medication, dietary restrictions, catheter care instructions, and safety instructions (including where to go and who to contact in the event of an adverse event of emergent situation). The funding body B. Braun Group (who is providing the vascular catheters used in this study) have provided device use and care training to all members of the study team within 12 weeks of recruitment of the first participant (completed 19/JAN/2023). The study team have also provided a study synopsis and training to all individuals involved. All individuals have completed Good Clinical Practice (GCP) training.

Procedure:
The vascular catheter location, will be assessed repeatedly over 72 hours using two- and three-dimensional ultrasound, as will assessment of vascular catheter patency and adverse events/failure mechanisms including thrombus formation and phlebitis. At the end of the trial participants will evaluate the benefits and preferences of the two devices tested through the completion of a participant experience survey.

WHO:
The devices will be inserted by a trained phlebotomist under ultrasound with a minimum of 5 years' experience. The devices will be assessed and imaged using ultrasound by a trained individual of over 2 years' experience. The vascular catheters will be flushed, and the insertion sites assessed, twice daily (AM and PM) by registered nurses.

HOW:
The control device (Introcan Safety) will be inserted individually in a face-to-face setting, with insertion of the comparator/control device taking up to 30 minutes.

WHERE:
The clinical trial will be undertaken at the Clinical Trials Unit (CTU), Building G40 at the Griffith University Gold Coast campus, Queensland Australia.

WHEN and HOW MUCH:
The control device will be delivered once to each participant, on the first interventional day. At each defined timepoint (up to 14 per participant), the sub-investigator will perform ultrasound assessment and imaging of the vascular catheter distal to the insertion site to image the catheter tip and its motion in the vessel. These images will then be used in data analysis.
Control group
Active

Outcomes
Primary outcome [1] 333594 0
Two-dimensional analysis of catheter motion in X, Y, Z planes between devices (interventional and control) at one timepoint on the first day of intervention, through measurement of the dynamic displacement of the vascular catheter tip using ultrasound, to provide data such as displacement, velocity, and total distance. A digital ruler will be used to measure distances (in cm and/or mm) to obtain data such as distance and displacement of the catheter tip in the vessel across X, Y and Z planes. The distance measurements can then be used with the time measurements (in seconds) obtained from the produced ultrasound DICOM files to calculate data such as velocity (distance over time) across X, Y and Z planes.
Timepoint [1] 333594 0
Up to 14 timepoints.

Day 1 - AM (before and after access of the vascular catheter) and PM (before and after access of the vascular catheter)
Day 2 - AM (before and after access of the vascular catheter) and PM (before and after access of the vascular catheter)
Day 3 - AM (before and after access of the vascular catheter) and PM (before and after access of the vascular catheter)
Day 4 - AM only (before and after access of the vascular catheter)
Primary outcome [2] 334160 0
Three-dimensional analysis, using ultrasound, of catheter motion in X, Y, Z planes between devices (interventional and control) and between each timepoint (up to 14 timepoints), through measurement of the static displacement of the vascular catheter tip. A digital ruler will be used to measure distance values (in cm and/or mm) which will then inform displacement values of the catheter in the X, Y and Z planes.
Timepoint [2] 334160 0
At a single timepoint, either AM or PM on the first day of intervention.
Secondary outcome [1] 417658 0
Analysis of venous segment

Three-dimensional analysis:
Vein segment volume in three-dimensions will be assessed between each timepoint of measurement (up to 14 timepoints) using three-dimensional ultrasound.
Timepoint [1] 417658 0
Up to 14 timepoints.

Day 1 - AM (before and after access of the vascular catheter) and PM (before and after access of the vascular catheter)
Day 2 - AM (before and after access of the vascular catheter) and PM (before and after access of the vascular catheter)
Day 3 - AM (before and after access of the vascular catheter) and PM (before and after access of the vascular catheter)
Day 4 - AM only (before and after access of the vascular catheter)
Secondary outcome [2] 417659 0
Analysis of vascular catheter patency and function, and assessment of insertion site for complications (adverse events).

Catheter patency will be assessed using ultrasound, and the flushing of saline through the device. If saline is unable to be flushed and/or no flashback is able to be obtained, the device will be deemed to have failed. Ultrasound will be able to further confirm device patency (e.g., if a thrombus has formed at the tip of the catheter in the vein, stopping flashback and flushing of saline from occurring).

Anticipated adverse events, which will be assessed through twice daily clinical examination by registered nurses, and through the use of ultrasound, include the following:
- Pain
- Nerve damage
- Haematoma
- Infection at the insertion site
- Infiltration/extravasation
- Thrombosis
- Thrombophlebitis
- Swelling/oedema
- Fainting
- Bleeding
- Exposure to blood (to participant or health care provider)
- Needlestick injury (to participant or health care provider)
- Systemic infection (bacteraemia)
- Fever/chills
- Pulmonary embolism
- Allergic reaction (e.g., to the adhesive used)
- Abuse/use of catheter by participant
- Psychological distress, nervousness or anxiety
- Electrical shock
Timepoint [2] 417659 0
Up to 7 timepoints.

Day 1 - AM (before flushing of the vascular catheter) and PM (before flushing of the vascular catheter)
Day 2 - AM (before flushing of the vascular catheter) and PM (before flushing of the vascular catheter)
Day 3 - AM (before flushing of the vascular catheter) and PM (before flushing of the vascular catheter)
Day 4 - AM only (before flushing of the vascular catheter)
Secondary outcome [3] 419392 0
Participant experience of catheter acceptability.
Timepoint [3] 419392 0
Focus group upon completion of data collection from all participants. The survey used will be formulated specifically for this study.
Secondary outcome [4] 419662 0
Participant experience of catheter acceptability.
Timepoint [4] 419662 0
Survey upon completion of final interventional visit (when both vascular catheters have failed or have been removed). The survey used will be formulated specifically for this study.
Secondary outcome [5] 419663 0
Analysis of thrombus volume.

Three-dimensional analysis:
Thrombus volume in three-dimensions will be assessed between each timepoint of measurement (up to 14 timepoints) using three-dimensional ultrasound.
Timepoint [5] 419663 0
Up to 14 timepoints.

Day 1 - AM (before and after access of the vascular catheter) and PM (before and after access of the vascular catheter)
Day 2 - AM (before and after access of the vascular catheter) and PM (before and after access of the vascular catheter)
Day 3 - AM (before and after access of the vascular catheter) and PM (before and after access of the vascular catheter)
Day 4 - AM only (before and after access of the vascular catheter)
Secondary outcome [6] 419864 0
Participant experience of catheter stability.
Timepoint [6] 419864 0
Survey upon completion of final interventional visit (when both vascular catheters have failed or have been removed). The survey used will be formulated specifically for this study.
Secondary outcome [7] 419886 0
Participant experience of catheter stability.
Timepoint [7] 419886 0
Focus group upon completion of data collection from all participants. The survey used will be formulated specifically for this study.

Eligibility
Key inclusion criteria
• Female or Male sex
• 18-65 years of age
• Not pregnant at time of recruitment and within 48 hrs of Day 1 procedures (self-reported)
• Normal haemotology results as per reference range determined by our laboratory.
• Normal coagulation results as per reference range determined by our laboratory.
• Target cephalic veins readily cannulatable (i.e., equal to approximately 2 mm)
• Able and willing to provide verbal and written consent
• Must be an Australian citizen with current Medicare card
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• History of pro coagulative state / condition (e.g., previous deep vein thrombosis)
• Currently on any anti-coagulant or platelet inhibitor medication. Use of NSAIDs and aspirin will be documented however are not exclusionary.
• Haemophilia or any current or history of bleeding disorder or tendency
• Presence or report of current blood borne disease/infection (e.g., hepatitis, HIV, leukemia, lymphoma)
• Difficult vascular access (i.e., vein must be readily palpable and cannulatable – no less than approximately 2 mm diameter
• Allergy or sensitivity to chlorhexidine gluconate, isopropyl alcohol, latex, or skin adhesives
• BMI less than 18.5 kg/m^2 or greater than 35 kg/m^2
• Positive results for the urine drug screen at screening or check-in (including opiates, methadone, cocaine, amphetamines)
• History or presence of alcoholism (self-reported) or drug abuse within the past 2 years
• A current or previous medical, physical, mental / cognitive disorder or anatomical conditions that, in the opinion of the chief or sub-investigator, would place the patient at risk, would make them unable to perform study procedures or has the potential to confound interpretation of the study results. (e.g., musculo-skeletal injury, chronic back pain)
• Employed by Becton Dickinson, Teleflex Medical, ICUMedical or BBraun (conflict of interest)

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Principal- or sub-investigator who is responsible for determining whether participants are eligible for inclusion into the trial are unaware of the participant allocation, which has been predetermined by the clinical trial coordinator, and concealed in an opaque envelope.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The method used to create the random order for the allocation of subjects into different groups was simple randomization using a randomization table created by computer software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Participants will receive the intervention and comparator/control treatment during the same visit. One device (either the control or intervention, this is randomised) will be inserted into one arm, with the opposite device inserted into the opposite arm. There will be no significant rest or break period between device insertions, with the second insertion occurring immediately after the first insertion.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Sample size calculation:
No studies have previously assessed catheter micro-motion from which a prospective sample size calculation can be based upon. However, based upon our experience using this human model. However, our previously published research has investigated the impact of increased flushing frequency on blood flow and thrombosis. It is assumed that increased catheter flushing results in additional micromotion and venous irritation, therefore, comparison of data from low versus high frequency flushing conditions would possess similarity to expected outcomes in this study. There, based upon these data, a sample size of 11-26 would be required to detect changes in blood velocity after cannulation (assuming an a:0.05 and ß;0.8; i.e. blood velocity increases as veins constrict due to shear induced injury/thrombus formation over time)*. We have erred on the side of caution and applied the more conservative estimate of 26 completed individuals to determine the extent of micromotion and assess response in clinical outcome. Whilst the planned number of completion number of participants is 26, it is anticipated that up to 40 participants will be recruited to be able to achieve the anticipated completion number of 26 participants, which the study is powered on.

*Keogh S, Hawthorn AM, Shibeeb S, Gurney L, Pennell EN, Sabapathy S, Rickard CM, Bulmer AC. Impact of Different Flushing Frequencies on Peripheral Intravenous Catheter Failure, Coagulation, and Tissue Injury—A Counterbalanced Preclinical Human Trial. Journal of the Association for Vascular Access, accepted 16/5/2022.


Statistical analysis plan:
Descriptive statistics for study endpoints and participants will be calculated. Univariate, bivariate and multiple regression analyses will be conducted to determine the impact of catheter design/type on endpoints measured. These will include, but are not limited to, correlation analysis, two-way analysis of variance (two-way ANOVA), general linear models and logistic regression analysis, and survival analysis will be completed.

Sub-analysis based on age, sex, dexterity, and medical history are also planned.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
17/04/2023
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 39312 0
4222 - Griffith University

Funding & Sponsors
Funding source category [1] 313364 0
Commercial sector/Industry
Name [1] 313364 0
B. Braun Group Australia and New Zealand
Country [1] 313364 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
1 Parklands Drive, Southport 4222 QLD
Country
Australia
Secondary sponsor category [1] 315120 0
None
Name [1] 315120 0
Address [1] 315120 0
Country [1] 315120 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312266 0
Griffith University Human Research Ethics Committee
Ethics committee address [1] 312266 0
Ethics committee country [1] 312266 0
Australia
Date submitted for ethics approval [1] 312266 0
21/11/2022
Approval date [1] 312266 0
09/01/2023
Ethics approval number [1] 312266 0
2022/915

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 124038 0
Prof Andrew Bulmer
Address 124038 0
Griffith University, 1 Parklands Drive, Southport QLD 4222
Country 124038 0
Australia
Phone 124038 0
+61 07 5552 8215
Fax 124038 0
Email 124038 0
[email protected]
Contact person for public queries
Name 124039 0
Andrew Bulmer
Address 124039 0
Griffith University, 1 Parklands Drive, Southport QLD 4222
Country 124039 0
Australia
Phone 124039 0
+61 07 5552 8215
Fax 124039 0
Email 124039 0
[email protected]
Contact person for scientific queries
Name 124040 0
Andrew Bulmer
Address 124040 0
Griffith University, 1 Parklands Drive, Southport QLD 4222
Country 124040 0
Australia
Phone 124040 0
+61 07 5552 8215
Fax 124040 0
Email 124040 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
As per our ethics approval, no individually identifiable data will be released. Participants will benefit from their data, via the provision of the published deidentified group data when our research publication is accepted and made publicly available. The research team have committed to publishing in open-access journal to ensure participant data is available.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.