The Effect of Near-infrared Spectroscopy on the Success of Peripheral Venous Access (PEDVEIN)

The Effect of Near-infrared Spectroscopy on the Success of Peripheral Venous Access: a Pilot Randomized Controlled Study

The goal of this clinical trial is to learn if using near-infrared imaging in pediatric vein cannulation is leading to higher success rate. The main question it aims to answer is:

is there higher success of first attempt in periferal vein cannulation? does it lower overall number of attempts to successful cannulation?

Study Overview

• Status: Recruiting
• Conditions: Intravenous Cannulation
• Intervention / Treatment: Device: Use of near-infrared imaging by VeinViewer Flex of periferal veins

Detailed Description

Providing venous access in pediatric anesthesia and intensive care is among the basic and necessary interventions for blood sampling and administration of drugs and possibly transfusion products and derivatives.

In anesthesia, effective provision of venous access is a prerequisite for safe anesthesia. In pediatric patients and newborns, provision of venous access is complicated by patient non-cooperation, but primarily by the smaller diameter of the vessels and often limited possibility of direct visualization, or limited possibility of palpation of the vessel under visual control. Ultrasound is currently used to facilitate provision of IV access, however, imaging under the USG probe and its subsequent puncture requires high skill of medical personnel and is preferentially applied by medical staff in the conditions of the Czech Republic. Near-infrared imaging (IR) allows direct visualization of superficial vascular bed and may potentially be associated with higher puncture success rates (higher first attempt success, reduction of total attempts).

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hana Harazim, MD, PhD; Phone Number: +420777146704; Email: harazim.hana@fnbrno.cz

Study Locations

• Czechia
  • South Moravian
    • Brno, South Moravian, Czechia, 60200
      • Recruiting
      • University Hospital Brno
      • Contact: Hana Harazim; Phone Number: 777146704; Email: hana.harazim@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Pediatric patients admitted to the inpatient section of the Department of Pediatric Anesthesiology and Resuscitation, Brno University Hospital
• Pediatric patients in the anesthesia section of the Department of Pediatric Anesthesiology and Resuscitation, Brno University Hospital
• Indicated insertion of peripheral venous access
• Consent of the patient/legal representative to the study

Exclusion Criteria:

• Disagreement with the study
• Not indicated insertion of peripheral venous access (according to clinical condition and decision of the attending physician)
• A device for near-infrared imaging of the venous bed is not available

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VeinViewer Flex; The periferal vein cannulation will be aided by concurrent near-infrared imaging by device VeinViewer Flex using AVIN™ (Active Vascular Imaging Navigation).	Device: Use of near-infrared imaging by VeinViewer Flex of periferal veins; The projected near-infrared light is absorbed by the blood and reflected by surrounding tissue, captured, processed, and digitally projected in real time directly onto the skin surface. It provides an accurate, real-time image of the patient's blood pattern. Patented VeinViewer technology using AVIN™ (Active Vascular Imaging Navigation) allows the blood vessels to be seen down to a depth of 10 mm. With VeinViewer, physicians can see peripheral veins, bifurcations, and valves and assess venous filling/flushing in real time.
No Intervention: Landmark; The peripheral vein cannulatoon will be provided by usual landmark technique, without any other imaging device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success rate of first attempt in peripheral vein cannulation	Success rate of first attempt in periferal vein cannulation	Periprocedural
Number of attempts	Overall number of attempts needed to secure periferal vein access	Periprocedural

Collaborators and Investigators

• Sponsor: Brno University Hospital
• Investigators: Principal Investigator: Petr Štourač, prof, MD, PhD, University Hospital Brno

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: November 17, 2025
• First Submitted That Met QC Criteria: December 11, 2025
• First Posted (Actual): December 12, 2025

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 25, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: pediatric; near-infrared imaging; difficult intravenous access; periferal vein cannulation
• Other Study ID Numbers: PEDVEIN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes