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

Peripheral Venous Catheterization 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: Terminated

Administrative data

• NCT number: NCT02265380
• Other study ID #: OMT-CT-002-PED
• Status: Terminated
• Phase: N/A
• First received: October 9, 2014
• Last updated: February 28, 2017
• Start date: October 2014
• Est. completion date: August 25, 2016

Study information

• Verified date: February 2017
• 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 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 188
• Est. completion date: August 25, 2016
• Est. primary completion date: August 25, 2016
• 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 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

Related Conditions & MeSH terms

• Peripheral Venous Catheterization

Intervention

Device:
• Placement of IV catheter

Locations

Country	Name	City	State
Finland	Helsinki and Uusimaa Hospital District, Children's Hospital	Helsinki

Sponsors (3)

Lead Sponsor	Collaborator
Optomeditech Oy	CardioMed Device Consultants, LLC, Helsinki and Uusimaa Hospital District, Children's Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Total number of attempts required for successful IV insertion		Immediate
Secondary	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
Secondary	Incidence of blood extravasation resulting in a hematoma		Up to 72 hours
Secondary	Incidence of fluid extravasation delivered through catheter		Up to 72 hours
Secondary	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
Secondary	Unplanned withdrawal of IV catheter		Up to 72 hours