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

NCT ID: NCT07279701

Last Updated: 2025-12-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-01
• Study Completion Date: 2026-12-31

Brief Summary

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?

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).

Conditions

Intravenous Cannulation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

VeinViewer Flex

The periferal vein cannulation will be aided by concurrent near-infrared imaging by device VeinViewer Flex using AVIN™ (Active Vascular Imaging Navigation).

Group Type: EXPERIMENTAL

Use of near-infrared imaging by VeinViewer Flex of periferal veins

Intervention Type: DEVICE

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.

Landmark

The peripheral vein cannulatoon will be provided by usual landmark technique, without any other imaging device.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 0 Days
• Maximum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brno University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Petr Štourač, MD

prof. MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Petr Štourač, prof, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Brno

Locations

University Hospital Brno

Brno, South Moravian, Czechia

Site Status: RECRUITING

Countries

Czechia

Central Contacts

Hana Harazim, MD, PhD

Role: CONTACT

harazim.hana@fnbrno.cz

+420777146704

Facility Contacts

Hana Harazim

Role: primary

hana.harazim@gmail.com

777146704

Other Identifiers

PEDVEIN

Identifier Type: -

Identifier Source: org_study_id