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| Name | Class |
|---|---|
| Queensland University of Technology | OTHER |
| University of Galway | OTHER |
| Poitiers University Hospital | OTHER |
| Terumo Corporation |
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Peripheral intravenous catheters (PIVCs; commonly known as "cannulas") are very small tubes made out of rubber-like materials which are inserted into patients' arms using a needle to allow easy access to veins. They are the most commonly-used medical devices in the world, with almost 10 million placed each year in Australia alone. Approximately 40% (almost 4 million) of these devices stop working (i.e. fail) prior to completion of therapy.
The main goal of this study is to learn if softer, more flexible PIVC tip materials reduce the angle of the catheter tip on the vein surface compared to less flexible materials. Reducing the angle of the tip is believed to reduce rubbing on the inner vein surface and causing irritation, extending the life of the catheter. Other goals of this study are to learn if softer materials affect: volume of oedema (i.e. fluid leakage around the vein); time until catheter failure; clot volume in the vein; changes in vein size in response to catheter insertion; adverse event rates (i.e. changes in rates of specific, reportable symptoms); and determining if certain catheters are better for some people than others. This study is recruiting participants of all genders aged 18 - 75 years old who:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Left More Flexible Right Less Flexible | Experimental | Participants in this arm will have a more flexible catheter placed in their left arm. |
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| Left Less Flexible Right More Flexible | Experimental | Participants in this arm will have a less flexible catheter placed in their left arm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bilateral Peripheral Intravenous Catheterisation | Device | Participants will have peripheral intravenous catheters inserted. Each participant will receive two different catheters (less flexible = 20 gauge ICUMedical SuperCath5 SP120-20-31T; more flexible = 20 gauge Becton Dickinson Insyte Autoguard Blood Control 381034), with the treatment arm (more flexible) being randomly assigned. |
| Measure | Description | Time Frame |
|---|---|---|
| Catheter Angle | Measured against inferior border of vein using vascular ultrasound (in degrees) | Baseline (Day 1: morning) |
| Measure | Description | Time Frame |
|---|---|---|
| Volume of interstitial oedema | Measured using vascular ultrasound (in mm cubed/microliters) | Morning visit (AM) after catheter insertion through to final interventional visit (up to 4 days) |
| Time to catheter failure |
| Measure | Description | Time Frame |
|---|---|---|
| Multiple regression analysis | Determining independent predictors from demographic data (i.e. biological sex (M/F)) on outcome measures (catheter dwell/failure time, thrombus/vessel/oedema measrements, adverse events). | Screening until follow-up appointment (screening period indeterminate, follow-up appointment completed up to 7 days post-insertion) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Principal Investigator | Griffith University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Griffith University | Southport | Queensland | 4215 | Australia |
All IPD that underlie results in a publication in an international peer-reviewed journal
Beginning from first participant enrolment with no end date
Only team members with direct participant interaction will have access to identifiable data. Other team members (e.g. statistician and computer scientists) will have access to de-identified data which will be limited only to that data which is necessary to complete their assigned role. The funder and general public will have access only to de-identified IPD that underlie results in the form of a published journal article. The funder and all members of the team will have access to the study protocol, SAP, ICF and CSR, but only team members listed on the Protocol have authority to influence/make changes to these documents.
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| ID | Term |
|---|---|
| D004487 | Edema |
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D002404 | Catheterization |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |
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| INDUSTRY |
| Queensland Health | OTHER_GOV |
Two catheters are being compared simultaneously using a bilateral cannulation model. Participants will be randomised for which catheter will be inserted into either arm, but all participants will be cannulated with both catheters. The randomisation algorithm will be designed to ensure that left- and right-hand dominant participants are distributed evenly across treatment arms.
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Measured separately for each PIVC (in hours), including differences between catheters and survival analysis.
| Morning visit (AM) after catheter insertion through to catheter removal and/or 72 hours post-insertion (whichever is earlier) |
| Thrombus volume in vein | Measured using vascular ultrasound (in mm cubed/microliters) | Morning visit (AM) after catheter insertion through to catheter removal and/or 72 hours post-insertion (whichever is earlier) |
| Vein segment volume | Measured by vascular ultrasound (in mm cubed/microliters) | Morning visit (AM) after catheter insertion through to catheter removal and/or 72 hours post-insertion (whichever is earlier) |
| Adverse Events | Identified by study team and/or nurses and reviewed by a medical practitioner (identified individually and aggregate of all adverse events; expressed as a count and percentage of catheters inserted). | Morning visit (AM) after catheter insertion through to follow-up visit (up to 7 days) |
| Multiple regression analysis |
Determining independent predictors from demographic data (i.e. age (years)) on outcome measures (catheter dwell/failure time, thrombus/vessel/oedema measrements, adverse events). |
| Screening until follow-up appointment (screening period indeterminate, follow-up appointment completed up to 7 days post-insertion) |
| Multiple regression analysis | Determining independent predictors from demographic (i.e. biological sex (M/F), age (years), height (cm), weight and height will be combined to report BMI in kg/m^2), family history of disease etc), haematologic (i.e. platelet, white/red blood cell counts [cells per microliter], clotting times [PT/APTT; sec], fibrinogen [mg/dL or g/L], DDimer [mg/L or ug/mL] etc and biochemical tests [liver [U/L] and kidney function tests mg/dL or umol/L], protein/s, petdides [ug/L or ng/mg protein], lipid profile (mmol/L), glucose (mg/dL or mmol/L) etc) on outcome measures (catheter dwell/failure time, thrombus/vessel/oedema measrements, adverse events). | Screening until follow-up appointment (screening period indeterminate, follow-up appointment completed up to 7 days post-insertion) |
| D002318 | Cardiovascular Diseases |