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

NCT02265380 | Terminated

• 1 other identifier: OMT-CT-002-PED
• Study Type: interventional
• Target: 188
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Venous Catheterization

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Total number of attempts required for successful IV insertion

  Immediate

• Time to successful IV insertion

  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)

  Up to 72 hours

Study Arms (2)

Treatment with OptiVein

EXPERIMENTAL

The patient will have an IV catheter placed with the use of OptiVein device.

Device: Placement of IV catheter

Treatment with Vasofix Certo

ACTIVE COMPARATOR

The patient will have an IV catheter placed with the use of Vasofix Certo device.

Device: Placement of IV catheter

Interventions

Placement of IV catheter DEVICE

Treatment with OptiVein; Treatment with Vasofix Certo

Eligibility Criteria

• Age: Up to 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Optomeditech Oy: lead
• Hospital District of Helsinki and Uusimaa: collaborator
• CardioMed Device Consultants, LLC: collaborator

Study Sites (1)

Helsinki and Uusimaa Hospital District, Children's Hospital

Helsinki, 00029, Finland

Location

Study Officials

• Tomi Taivainen, MD, PhD

  Hospital District of Helsinki and Uusimaa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2014
• First Posted: October 15, 2014
• Study Start: October 1, 2014
• Primary Completion: August 25, 2016
• Study Completion: August 25, 2016
• Last Updated: March 1, 2017

Record last verified: 2017-02

Locations

FI (1)