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

Official title

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

Overview

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).

Interventions

• 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 f

Primary outcome measures

• Success rate of first attempt in peripheral vein cannulation [Time frame: Periprocedural]
• Number of attempts [Time frame: Periprocedural]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

Czechia · 1 center

• University Hospital Brno — Brno

Identifiers

NCT: NCT07279701 · PEDVEIN

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗