Near-Infrared Light for Peripheral Venous Catheterization in Adults With Difficult Venous Access

NCT07867132 | Not Yet Recruiting

• 2 other identifiers: 660GRS/3204/A2/2025
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical trial is to learn whether near-infrared (NIR) light can help healthcare professionals place a peripheral intravenous catheter in adults with difficult venous access. The main question it aims to answer is: \- Does using NIR light make successful catheter placement on the first needle puncture more likely than the usual method of looking for and feeling the vein? Researchers will compare NIR light with the usual method of looking for and feeling the vein to see which method works better for placing the catheter on the first needle puncture. Participants will:

• Have their veins located using either NIR light or the usual method of looking for and feeling the vein.
• Have a peripheral intravenous catheter placed by a healthcare professional.
• Report their pain and satisfaction with the procedure. Researchers will also record how many needle punctures are needed, how long catheter placement takes, how long the catheter remains in place, why it is removed, and whether any complications occur.

Conditions

Difficult Venous Access

Keywords

Peripheral Intravenous Catheterization; Near-Infrared Light; Vein Visualization; Difficult Venous Access; Peripheral Intravenous Catheter

Outcome Measures

Primary Outcomes (1)

• Successful Peripheral Intravenous Catheterization on the First Venipuncture Attempt

  Successful catheterization will be defined as venous blood return upon vein entry, advancement of the peripheral intravenous catheter without resistance, and, after tourniquet release, administration of 5-10 mL of saline or initiation of intravenous infusion without resistance, infiltration, or pain. Blood return after final catheter positioning will not be required. The outcome will be recorded as successful or unsuccessful on the first venipuncture attempt.

  During the peripheral intravenous catheter insertion procedure

Study Arms (2)

Near-Infrared Light

EXPERIMENTAL

Participants assigned to this arm will undergo peripheral intravenous catheterization after vein localization using near-infrared light. Catheter insertion will otherwise follow the standard procedure.

Device: Near-Infrared Vein Visualization Device

Conventional Vein Localization

ACTIVE COMPARATOR

Participants assigned to this arm will undergo peripheral intravenous catheterization after vein localization using direct visualization and palpation of the vein, without technological assistance. Catheter insertion will otherwise follow the standard procedure.

Procedure: Conventional Vein Localization

Interventions

Near-Infrared Vein Visualization Device DEVICE

A near-infrared vein visualization device will be used to locate superficial veins for peripheral intravenous catheter insertion. The device uses near-infrared light to visualize the venous pattern and projects the resulting vein image onto the participant's skin in real time. The device will be used for vein localization before venipuncture and may remain in use during venipuncture and catheter insertion at the healthcare professional's discretion. Peripheral intravenous catheter insertion will otherwise follow the standard procedure.

Near-Infrared Light

Conventional Vein Localization PROCEDURE

ein localization will be performed using the conventional method of direct visualization and palpation of the vein, without the use of near-infrared or other vein visualization technology. Peripheral intravenous catheter insertion will then be performed according to the standard procedure.

Conventional Vein Localization

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18 years or older who require intravenous treatment expected to last less than one week and that can be administered through a short peripheral intravenous catheter (PIVC) to be inserted in a participating hospital unit.
• A score of 4 or higher on the A-DIVA scale.
• Written informed consent to participate in the study

You may not qualify if:

• Patients with an existing peripherally inserted central catheter (PICC), centrally inserted central catheter (CICC), femorally inserted central catheter (FICC), implanted vascular access device (PICC-Port or intravenous port), or tunneled vascular access device.
• Patients requiring intravenous treatment that is not appropriate for administration through a short PIVC according to the RNAO vascular access guideline, including solutions with pH \<5 or \>9, osmolarity \>500 mOsm/L, vesicant medications, vasoactive drugs, or parenteral nutrition.

Sponsors & Collaborators

• Raquel López Nieto: lead
• Gerencia Regional de Salud de Castilla y Leon: collaborator

Study Officials

• Raquel López Nieto

  Complejo Asistencial de Zamora.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Raquel López Nieto

CONTACT

+34 980 548 200; rlopezni@saludcastillayleon.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Nurse

Study Record Dates

• First Submitted: October 5, 2026
• First Posted: October 9, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): October 31, 2027
• Last Updated: October 9, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share