Peripheral Venous Catheterization Clinical Trial
Official title:
A Randomized Controlled Trial to Demonstrate the Safety and Efficacy of the OptiVein IV Catheter In a Pediatric Population
A prospective, single-center, open-label, randomized controlled trial to demonstrate the safety and efficacy of the OptiVein IV Catheter in the pediatric population. The study hypothesis is that OptiVein IV Catheter use will be superior to the control in successful venous access after first attempt.
The OptiVein System uses transillumination of skin tissue to aid in cannulation and consists
of the OptiVein IV Catheter with an integrated optical fiber, and an electronic unit. The
electronic unit is a portable internally powered generator of low power visible laser light
of green color. The electronic unit generates visible light, which is released from the tip
of the needle into the soft tissue around the tip of the IV catheter. Light is visible
through the skin and helps mark the location of the tip of the needle under the skin and
against the vein.
In addition to pinpointing the exact location of the tip of the needle, the OptiVein System
informs the user of the exact moment of penetration of the tip of the needle into the blood
vessel. Hemoglobin in blood strongly absorbs visible light of specific wavelengths, so when
the needle enters the blood vessel, the light is instantly absorbed by blood, which causes
instant fading of skin transillumination. Instant disappearance of tissue illumination
indicates successful venipuncture. The user can then lower the angle of the needle and start
to advance the cannula over the needle into the blood vessel. Such optical confirmation is
much faster than the traditional observation of blood in the flashback chamber of the needle
and should lead to increased first-attempt success rates and decreased cannulation-related
complications.
The use of OptiVein device will be compared to the use of a traditional IV catheter to
explore the potential increase of effectiveness of cannulation with OptiVein versus
traditional IV catheters.
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