A Randomized Controlled Trial to Demonstrate the Safety and Efficacy of the OptiVein IV Catheter In a Pediatric Population

Optomeditech

Status

Terminated

Conditions

Peripheral Venous Catheterization

Treatments

Device: Placement of IV catheter

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02265380

OMT-CT-002-PED

Details and patient eligibility

About

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.

Full description

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.

Enrollment

188 estimated patients

Sex

All

Ages

Under 12 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Aged newborn to 12 years
Has written or verbal order for insertion of an IV
Requires peripheral IV therapy (catheter)
Has an insertion site in the hand, forearm, foot, leg, or head free of deformities, phlebitis, infiltration, dermatitis, burns, lesions or tattoos
Demonstrates cooperation with a catheter insertion and the study protocol

Exclusion criteria

In the newborn nursery or intensive care units (neonatal or pediatric)
On patient-controlled analgesia pump
Patient is anesthetized
Terminally ill
Transferred from the operating room less than 8 hours postanasthesia
Any child the research staff deem unobservable
The study IV catheter site will be placed below an old infusion site
The study IV site needs to be immobilized with a splint or other devices
Has or has had a previous IV catheter related phlebitis or infiltration during current hospitalization
Will require a power injection for a radiologic procedure during participation in this study