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.

Study Overview

• Status: Terminated
• Conditions: Peripheral Venous Catheterization
• Intervention / Treatment: Device: Placement of IV catheter

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.

• Study Type: Interventional
• Enrollment (Anticipated): 188
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Helsinki, Finland, 00029
    • Helsinki and Uusimaa Hospital District, Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment with OptiVein; The patient will have an IV catheter placed with the use of OptiVein device.	Device: Placement of IV catheter
Active Comparator: Treatment with Vasofix Certo; The patient will have an IV catheter placed with the use of Vasofix Certo device.	Device: Placement of IV catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Successful IV insertion on the first attempt	Successful IV insertion on the first attempt, defined as placement of the catheter inside the vein allowing for fluid or drug delivery or blood withdrawal.	Immediate

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total number of attempts required for successful IV insertion		Immediate
Time to successful IV insertion	Defined as time from the first skin puncture to placement of the catheter inside the vein allowing for fluid or drug delivery or blood withdrawal.	Immediate
Incidence of blood extravasation resulting in a hematoma		Up to 72 hours
Incidence of fluid extravasation delivered through catheter		Up to 72 hours
Incidence of infection (phlebitis, dermatitis and induration)	Incidence of infection (phlebitis, dermatitis and induration) at insertion site through 72 hours or at the time of catheter removal, whichever occurs first.	Up to 72 hours
Unplanned withdrawal of IV catheter		Up to 72 hours

Collaborators and Investigators

• Sponsor: Optomeditech Oy
• Collaborators: Hospital District of Helsinki and Uusimaa; CardioMed Device Consultants, LLC
• Investigators: Principal Investigator: Tomi Taivainen, MD, PhD, Hospital District of Helsinki and Uusimaa

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Actual): August 25, 2016
• Study Completion (Actual): August 25, 2016

Study Registration Dates

• First Submitted: October 9, 2014
• First Submitted That Met QC Criteria: October 14, 2014
• First Posted (Estimate): October 15, 2014

Study Record Updates

• Last Update Posted (Actual): March 1, 2017
• Last Update Submitted That Met QC Criteria: February 28, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: OMT-CT-002-PED