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

Injections, Intravenous Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03145519
• Other study ID #: OMT-CT-004-PED
• Status: Completed
• Phase: N/A
• Start date: February 15, 2017
• Est. completion date: September 17, 2017

Study information

• Verified date: September 2018
• Source: Optomeditech Oy
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The OptiVein IV Catheter is a sterile single use disposable intravascular cannulation device that is modified from CE certified Vasofix Certo Catheter from B.Braun with the additional features of an optical fiber and modified flashplug. The OptiVein System also includes an electronic unit.

The OptiVein Catheter shares a similar intended use and the same catheter components as the Vasofix Certo IV Catheter. Clinical data will be obtained to demonstrate that there is no change to the safety and efficacy profile due to the laser component of the OptiVein IV Catheter.

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.

Patients aged newborn to twelve (12) years requiring short-term use of an IV catheter to withdraw blood samples or to administer fluids or medications intravenously.

Participating sites will follow routine practice guidelines regarding the personnel responsible for inserting the catheters for this study, known herein as "operators." Operators must be professionally trained in IV catheter placement; educational background and level of experience of operator will be documented.

All Operators selected for participation in the study will undergo training on the protocol, Good Clinical Practice and the assembly and use of the OptiVein IV Catheter and Vasofix Certo IV catheter prior to enrolling patients into the study.

Randomization will be in a 1:1 fashion with assignment given by the electronic data capture (EDC) system.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 188
• Est. completion date: September 17, 2017
• Est. primary completion date: September 17, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 12 Years

Eligibility

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 forearm, hand, foot, leg, or head free of deformities, phlebitis, infiltration, dermatitis, burns, lesions or tattoos

• Demonstrates cooperation with a catheter insertion and the study protocol

• Informed consent has been obtained

Exclusion Criteria:

• Life expectancy less than 72h.

• Any child the research staff deem unobservable

• The study IV catheter site will be placed below an old infusion site

• Will likely require a power injection for a radiologic procedure during participation in this study

Related Conditions & MeSH terms

• Administration, Intravenous
• Injections, Intravenous

Intervention

Device:
• Vasofix Certo Catheter
Placement of IV-catheter
• OptiVein Catheter
Placement of IV-catheter

Locations

Country	Name	City	State
Estonia	Tartu University Hospital, Children's Clinic	Tartu

Sponsors (2)

Lead Sponsor	Collaborator
Optomeditech Oy	CardioMed Device Consultants, LLC

Country where clinical trial is conducted

Estonia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	First attempt success rate	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 / During the procedure usually taking less than 1 minute
Secondary	Number of attempts	Total number of attempts required for successful IV insertion.	Immediate / During the consecutive attempts to place the catheter, usually less than 30 minutes
Secondary	Time to successful IV insertion	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 / During the procedure usually taking less than 1 minute if successful with first stick or within 30 minutes if further attempts are required
Secondary	Incidence of blood extravasation resulting in a hematoma		Immediate / 72 hour follow-up or time of removal of catheter, whichever occurs first
Secondary	Incidence of fluid extravasation delivered through catheter		Immediate / 72 hour follow-up or time of removal of catheter, whichever occurs first
Secondary	Incidence of infection	Incidence of infection (phlebitis, dermatitis and induration) at insertion site through 72 hours or at the time of catheter removal, whichever occurs first.	72 hour follow-up or time of removal of catheter, whichever occurs first
Secondary	Unplanned withdrawal of IV catheter		72 hour follow-up or time of removal of catheter, whichever occurs first
Secondary	Overall complication rate composed from #2-5 above		72 hour follow-up or time of removal of catheter, whichever occurs first