Clinical trial NCT02265380: A Randomized Controlled Trial to Demonstrate the Safety and Efficacy of the OptiVein IV Catheter In a Pediatric Population
Official title: A Randomized Controlled Trial to Demonstrate the Safety and Efficacy of the OptiVein IV Catheter In a Pediatric Population
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Peripheral Venous Catheterization
Lead sponsor: Optomeditech Oy
Sponsor class: INDUSTRY
Collaborators: name: Hospital District of Helsinki and Uusimaa
name: CardioMed Device Consultants, LLC
First posted: 2014-10-15
Enrollment: 188
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Successful IV insertion on the first attempt
timeFrame: Immediate
Secondary outcomes:
measure: Total number of attempts required for successful IV insertion
timeFrame: Immediate
measure: Time to successful IV insertion
timeFrame: Immediate
measure: Incidence of blood extravasation resulting in a hematoma
timeFrame: Up to 72 hours
measure: Incidence of fluid extravasation delivered through catheter
timeFrame: Up to 72 hours
measure: Incidence of infection (phlebitis, dermatitis and induration)
timeFrame: Up to 72 hours
measure: Unplanned withdrawal of IV catheter
timeFrame: Up to 72 hours
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Helsinki and Uusimaa Hospital District, Children's Hospital
Study officials:
affiliation: Hospital District of Helsinki and Uusimaa
name: Tomi Taivainen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: