A Trial to Demonstrate the Safety and E… | Clinical Trial

Key information

Conditions

Injections, Intravenous Administration, Intravenous

Age range

Up to 12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tartu University Hospital, Children's Clinic

Tartu, 51014, Estonia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vasofix Certo Catheter

Device

Placement of IV-catheter

OptiVein Catheter

Device

Placement of IV-catheter

Primary outcomes

First attempt success rate

Time frame: Immediate / During the procedure usually taking less than 1 minute

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.

Secondary outcomes

Number of attempts

Time frame: Immediate / During the consecutive attempts to place the catheter, usually less than 30 minutes

Total number of attempts required for successful IV insertion.
Time to successful IV insertion

Time frame: Immediate / During the procedure usually taking less than 1 minute if successful with first stick or within 30 minutes if further attempts are required

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
Incidence of blood extravasation resulting in a hematoma

Time frame: Immediate / 72 hour follow-up or time of removal of catheter, whichever occurs first
Incidence of fluid extravasation delivered through catheter

Time frame: Immediate / 72 hour follow-up or time of removal of catheter, whichever occurs first
Incidence of infection

Time frame: 72 hour follow-up or time of removal of catheter, whichever occurs first

Incidence of infection (phlebitis, dermatitis and induration) at insertion site through 72 hours or at the time of catheter removal, whichever occurs first.
Unplanned withdrawal of IV catheter

Time frame: 72 hour follow-up or time of removal of catheter, whichever occurs first
Overall complication rate composed from #2-5 above

Time frame: 72 hour follow-up or time of removal of catheter, whichever occurs first

Sponsors and collaborators

Lead sponsor

Optomeditech Oy

Industry

Collaborators

CardioMed Device Consultants, LLC

Registry information

Official study title

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

Important dates

Study start: 2017
Primary completion: 2017
Study completion: 2017
First posted: May 9, 2017
Registry last updated: Sep 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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