Peripheral Intravenous Catheters
Conditions
Keywords
IV Catheters, Blood control
Brief summary
The purpose of this pilot study is to collect the necessary information for determining the appropriate sample size of a statistically powered trial comparing the performance of two different blood control peripheral intravenous catheters.
Interventions
DEVICEViaValve Safety IV Catheter
Insertion of the peripheral intravenous catheters into both upper extremities of subjects
DEVICEInsyte Autoguard BC [Blood Control] Shielded IV Catheter
Sponsors
Smiths Medical, ASD, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 18 years of age or older * Willing and able to independently sign an English Informed Consent * Have adequate veins for placement of IV catheters in both right and left upper extremities
Exclusion criteria
* Currently taking anti-coagulation medication * Have a known bloodborne disease or bleeding tendency * Have a known fear or adverse reaction to needles or blood * Women who are pregnant or nursing
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical performance and acceptability | IV catheters will be inserted, secured to subjects, and then immediately removed. Data regarding the insertion process will then be immediately collected. | Primary outcome measure will be a composite of user ratings evaluating clinical performance and acceptability of each device via a 6-point Likert questionnaire. |
Countries
United States
Outcome results
None listed