Near-Infrared Light Devices Versus Landmark Approach for Peripheral Venous Access in Intensive Care Unit

NCT06234293 | Completed

• 1 other identifier: CHRO-2022-14
• Study Type: interventional
• Target: 380
• Locations: 1 country
• Sites: 4

Brief Summary

The central venous catheter (CVC) is commonly used in intensive care unit (ICU). The primary complications associated with CVCs especially with prolonged use include thrombosis and infections. Hence, it is essential to remove the CVC as soon as it becomes unnecessary. Peripheral intravenous cannulation (PIVC) on a critically ill patient can be a significant challenge for nurses. After several days in ICU, patients may develop significant edema in the upper limbs, complicating the PIVC. Near-infrared light devices (NILD) are medical devices that use near-infrared light to highlight the patient's peripheral venous network directly on their skin. The advantage of this device is its minimal training and ease of use for effective application. Nurses can use this medical device without specific conditions once they have received training on its use. The vein illuminator has not been extensively studied in ICU. This study aims to compare two techniques for PIVC in critically ill patients with existing CVC for whom maintaining the deep venous access is no longer indicated. The investigators hypothesize that the use of the NILD would increase the success rate of first-attempt PIVC insertion compared to a landmark approach (traditional method) for PIVC in ICU.

Conditions

Upper Limb Edema; Critical Illness

Keywords

Intensive Care Unit; Peripheral Venous Access; Landmark approach; Near-infrared light device; PIVC

Outcome Measures

Primary Outcomes (1)

• Success rate on the first attempt of PIVC in ICU using NILD

  To show that the use of the NILD improves the success rate on the first attempt of PIVC in ICU for patients for whom the use of a deep venous catheter is no longer justified. The success of PIVC will be determined by the presence of venous return during catheterization in the reflux chamber, the full catheter introduction, and the administration of a 10cc syringe of isotonic solution (NaCl 0.9%) with a flash without extravasation. A puncture attempt is defined by the effraction of the skin barrier by the device. During a puncture, repositioning/change of catheter direction is permitted. Peripheral intravenous puncture will be performed by nurses only.

  Baseline

Secondary Outcomes (6)

• number of attempts before successful PIVC

  Baseline

• occurrence of local complications

  Day 7

• success rate of PIVC according to nurses's experience

  Baseline

• success rate of PIVC in patients considered with anticipated difficult intravenous access

  Baseline

• PIVC insertion time

  Baseline

Study Arms (2)

near-infrared light device

EXPERIMENTAL

the device used is the AccuVein AV500® (Accuvein, New York USA). Nurses will have to find the vein for the PIVC using the near-infrared light device. Nurses will have to proceed as follows: apply the tourniquet, put on the near infrared light onto the upper limb. PIVC on the lower limbs is forbidden in this study. The recommended projection distance is around 20 cm, however, the optimal distance of projection can vary between 10 and 45 cm. After finding the vein, Nurses proceed to PIVC with the device turned on, the peripheral venous network visible on the skin of the patient. After the cannulation and to confirm the functionality of the peripheral intravenous access a flash of 10cc of an isotonic solution (NaCl 0.9%) will be injected

Device: near-infrared light device

landmark approach

NO INTERVENTION

PIVC will be done by a nurse on an upper limb according to the standard approach. The nurse will proceed as follows: apply the tourniquet and find a vein for the catheterization, standard techniques to highlight veins can be used (apply alcohol, tap veins …). After finding a vein, the nurses proceed to the PIVC according to his / her habits. The use of any device is forbidden. After the cannulation and to confirm the functionality of the peripheral venous access a flash of 10cc of an isotonic solution (NaCl 0.9%) will be injected.

Interventions

near-infrared light device DEVICE

Nurses will have to find the vein for the PIVC using the near-infrared light device.

near-infrared light device

Eligibility Criteria

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

You may qualify if:

• ≥18 years old
• Hospitalized in ICU
• with a deep venous catheter (jugular, subclavian or femoral)
• In whom the use of a deep venous line is no longer justified (absence of: vasopressor amines, chemotherapy, parenteral nutrition, hypertonic solutions)

You may not qualify if:

• Absolute contraindication or anatomical impossibility to perform a PIVC on the upper limbs
• Patient already included in the study
• Tattoo covering most of both forearms
• Adult subject to a legal protection measure (guardianship, curators, person under court protection)
• Persons deprived of their liberty by a judicial or administrative decision, persons hospitalised without consent and persons admitted to a health or social establishment for purposes other than research.
• Pregnant or breast-feeding woman

Sponsors & Collaborators

• Centre Hospitalier Régional d'Orléans: lead

Study Sites (4)

CH de Chartres

Chartres, France

Location

CH Le Mans

Le Mans, France

Location

CHU Orléans

Orléans, France

Location

CHU de Tours

Tours, France

Location

Related Publications (6)

• Gregg SC, Murthi SB, Sisley AC, Stein DM, Scalea TM. Ultrasound-guided peripheral intravenous access in the intensive care unit. J Crit Care. 2010 Sep;25(3):514-9. doi: 10.1016/j.jcrc.2009.09.003. Epub 2009 Oct 15.

  PMID: 19836193 BACKGROUND

• Carr PJ, Rippey JCR, Cooke ML, Trevenen ML, Higgins NS, Foale AS, Rickard CM. Factors associated with peripheral intravenous cannulation first-time insertion success in the emergency department. A multicentre prospective cohort analysis of patient, clinician and product characteristics. BMJ Open. 2019 Apr 2;9(4):e022278. doi: 10.1136/bmjopen-2018-022278.

  PMID: 30944127 BACKGROUND

• Bridey C, Thilly N, Lefevre T, Maire-Richard A, Morel M, Levy B, Girerd N, Kimmoun A. Ultrasound-guided versus landmark approach for peripheral intravenous access by critical care nurses: a randomised controlled study. BMJ Open. 2018 Jun 9;8(6):e020220. doi: 10.1136/bmjopen-2017-020220.

  PMID: 29886442 BACKGROUND

• Curtis SJ, Craig WR, Logue E, Vandermeer B, Hanson A, Klassen T. Ultrasound or near-infrared vascular imaging to guide peripheral intravenous catheterization in children: a pragmatic randomized controlled trial. CMAJ. 2015 May 19;187(8):563-570. doi: 10.1503/cmaj.141012. Epub 2015 Apr 20.

  PMID: 25897047 BACKGROUND

• Park JM, Kim MJ, Yim HW, Lee WC, Jeong H, Kim NJ. Utility of near-infrared light devices for pediatric peripheral intravenous cannulation: a systematic review and meta-analysis. Eur J Pediatr. 2016 Dec;175(12):1975-1988. doi: 10.1007/s00431-016-2796-5. Epub 2016 Oct 26.

  PMID: 27785562 BACKGROUND

• Ferrier A, Despres A, Brasselet A, Badre G, Wanneveich M, Nay MA. Near-infrared light devices versus landmark approach for peripheral venous access in the intensive care unit: protocol of a randomised controlled study. BMJ Open. 2025 Aug 18;15(8):e102390. doi: 10.1136/bmjopen-2025-102390.

  PMID: 40829834 DERIVED

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Aude FERRIER

  CHU Orléans

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Randomized controlled multicenter trial Ratio 1:1

Study Record Dates

• First Submitted: January 15, 2024
• First Posted: January 31, 2024
• Study Start: February 28, 2024
• Primary Completion: July 9, 2025
• Study Completion: July 16, 2025
• Last Updated: January 13, 2026

Record last verified: 2026-01

Locations

FR (4)