Peripheral Intravenous Catheter
Conditions
Keywords
peripheral intravenous catheters, blood exposure, blood control, IV catheter insertion
Brief summary
The objective of this post-market, prospective study is to evaluate the clinical acceptability, blood leakage, risk for blood exposure, need for digital compression, insertion success, and clinical utility of the ViaValve™ Safety IV Catheter compared to standard hospital PIVCs currently being used.
Interventions
DEVICEProtectIV® Plus Safety IV Catheter
Safety peripheral IV catheter with no blood control feature
DEVICEViaValve™ Safety IV Catheter
Safety peripheral IV catheter with a blood control feature
Sponsors
Smiths Medical, ASD, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* A peripheral intravenous catheter will need to be inserted in order to gain access to a vein or artery to sample blood, monitor blood pressure, or administer fluids intravenous infusion as part of treatment. * Willing and able to sign an Informed Consent (patient or legally authorized representative).
Exclusion criteria
* Body morphology (e.g., size) precludes the use of a peripheral intravenous catheter. * Fluid to be infused is not appropriate for peripheral intravenous catheters.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical acceptability of PIVC insertion | Clinicians will provide the rating immediately after performing the insertion | Demonstrate non-inferiority of the ViaValve™ Safety I.V. Catheter compared to the control PIVC for ratings of clinical acceptability. Clinicians will agree or disagree that the device was clinically acceptable for the insertion. |
| Frequency of blood leakage | Clinicians will report if blood leakage occurred immediately after the catheter insertion | Demonstrate superiority of the ViaValve™ Safety I.V. Catheter compared to the control in preventing blood leakage from the catheter hub during insertion. |
| Eliminating risk of blood exposure | Clinicians will report on the ability of the PIVC to eliminate blood exposure immediately after catheter insertion | Demonstrate superiority of the ViaValve™ Safety I.V. Catheter compared to the control PIVC in eliminating the clinician's risk of blood exposure during the insertion process. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Insertion success | Clinicians will report if the insertion was successful immediately after performing insertion | Demonstrate the insertion success rate of the ViaValve™ I.V. Catheter is non-inferior to the control PIVC. Insertion success defined as a catheter confirmed successfully placed within the selected vessel in 3 or fewer venipuncture attempts. |
| Elimination of digital compression | Clinicians will provide the rating immediately after performing the insertion | Demonstrate that the ViaValve™ Safety I.V. Catheter is non-inferior to the control PIVC in eliminating the clinician's need to use digital compression during the insertion process. Clinicians will agree or disagree the device eliminates the need for digital compression after each PIVC insertion. |
| Ease of Use | Clinicians will provide the rating immediately after performing the insertion | Demonstrate that the ViaValve™ Safety I.V. Catheter is non-inferior to the control PIVC in seven measures of ease of use. Clinicians will agree or disagree with seven statements regarding ease of use/clinical utility. |
Countries
Canada
Outcome results
None listed