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NCT Number: NCT06234293

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

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.

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Key information

Conditions

Upper Limb Edema Critical Illness Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CH de Chartres, Chartres, France

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About this study

This is a multicenter randomized controlled study. 380 patients will be randomly assigned with a 1:1 ratio to landmark approach (standard group) or near-infrared light device (interventional group).

Randomization will be done immediately after the enrollment of the patient. Randomization will be stratified by center and according to anticipated difficult venous access defined by:

  • BMI > 30 Kg/m2
  • Increase in body weight between admission and day of inclusion > 10%.
  • Clinically evident edema of the upper limbs (with pitting)
  • Absence of visible or palpable veins on arms and forearms If one or more items are present, the patient is classified as difficult to venous access.

Once the patient has been enrolled and randomized, the nurse in charge of the patient performs the PIVC according to the randomization group as soon as possible after randomization.

The nurse will have a maximum of 3 attempts before handing over to another nurse. The total number of attempts will be 5 with the allocated method (traditional method or NILD).

In the case of failure after 5 initial attempts, the intervention will be considered as a failure. However, a maximum of 5 additional attempts will be allowed with any method on the day of randomization. The success or failure of PIVC will be recorded, as well as the device used. The attempts should be performed within 6 hours after randomization.

If one of the 5 first initial attempts is successful, the study continues until the PIVC is removed (max 7 days according to recommendations) or patient discharge, whichever comes first, in order to evaluate the occurrence of local complications.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≥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)

Exclusion criteria

  • 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

Treatment and study plan

near-infrared light device

Device

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

Primary outcomes

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

    Time frame: Baseline

    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.

Secondary outcomes

  1. number of attempts before successful PIVC

    Time frame: Baseline

    Compare the number of attempts before successful PIVC between the traditional method (standard group) and the use of NILD (interventional group).

    The number of puncture attempts will be defined by the number of attempts between inclusion and successful of PIVC (last attempt included). On the day of inclusion in the study, each nurse has a maximum of three attempts at PIVC, per patient, depending on the randomization arm. The maximum number of initial attempts per patient is 5.

  2. occurrence of local complications

    Time frame: Day 7

    Compare the occurrence of local complications (phlebitis, extravasation) between the two groups in patients for whom PIVC is considered successful.

    • The occurrence and type of local complications within 7 days of successful PIVC will be compared between the two groups, as well as their time of occurrence after placement (until removal of the medical device or until discharge from the hospital department). if the patient is discharged before 7 days).

    The main local complications are venous inflammation and extravasation. Local signs to watch out for include pain, swelling and induration. The presence of any of these signs during daily monitoring will lead to its withdrawal. Only medical confirmation of venous inflammation and extravasation will be recorded for this study.

  3. success rate of PIVC according to nurses's experience

    Time frame: Baseline

    Compare the success rate of PIVC according to nurses' experience between the two groups.

    The success rate or PIVC according to nurses-experience between the two groups will be compared by stratification: nurses with less than one year's nursing experience, between 1 to 5 years' experience and more than 5 years.

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

    Time frame: Baseline

    Compare the success rate of PIVC in patients considered with anticipated difficult intravenous access between the two groups.

    • Anticipated difficult PIVC will be defined as follows:
    • Presence of upper limb edema
    • Absence of palpable veins when applying a tourniquet
    • Obese patient defined as BMI > 30 kg/m2
    • Increase in body weight between admission and day of inclusion > 10%

  5. PIVC insertion time

    Time frame: Baseline

    Compare PIVC insertion time between the two groups

  6. pain levels

    Time frame: Baseline

    Compare pain levels in conscious patients between the two groups using the pain verbal analog scale from 0 to 10, where 0 is no pain and 10 unbearable pain.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Régional d'Orléans

Other

Registry information

Official study title

Near-Infrared Light Devices Versus Landmark Approach for Peripheral Venous Access in Intensive Care Unit: A Randomized Controlled Study

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 31, 2024
Registry last updated
Jan 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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