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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02265380
• Date of registration: 09/10/2014
• Prospective Registration: No
• Primary sponsor: Optomeditech Oy
• Public title: A Randomized Controlled Trial to Demonstrate the Safety and Efficacy of the OptiVein IV Catheter In a Pediatric Population
• Scientific title: A Randomized Controlled Trial to Demonstrate the Safety and Efficacy of the OptiVein IV Catheter In a Pediatric Population
• Date of first enrolment: October 2014
• Target sample size: 188
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02265380
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Finland

Contacts

• Name: Tomi Taivainen, MD, PhD
• Affiliation: Helsinki and Uusimaa Hospital District, Children's Hospital

Key inclusion & exclusion 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



Age minimum: N/A
Age maximum: 12 Years
Gender: All

Health Condition(s) or Problem(s) studied

Peripheral Venous Catheterization

Intervention(s)

Device: Placement of IV catheter

Primary Outcome(s)

Successful IV insertion on the first attempt [Time Frame: Immediate]

Secondary Outcome(s)

Time to successful IV insertion [Time Frame: Immediate]

Unplanned withdrawal of IV catheter [Time Frame: Up to 72 hours]

Incidence of fluid extravasation delivered through catheter [Time Frame: Up to 72 hours]

Total number of attempts required for successful IV insertion [Time Frame: Immediate]

Incidence of infection (phlebitis, dermatitis and induration) [Time Frame: Up to 72 hours]

Incidence of blood extravasation resulting in a hematoma [Time Frame: Up to 72 hours]

Secondary ID(s)

OMT-CT-002-PED

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

CardioMed Device Consultants, LLC

Helsinki and Uusimaa Hospital District, Children's Hospital