Clinical trial NCT06234293: Near-Infrared Light Devices Versus Landmark Approach for Peripheral Venous Access in Intensive Care Unit
Official title: Near-Infrared Light Devices Versus Landmark Approach for Peripheral Venous Access in Intensive Care Unit: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Upper Limb Edema
Critical Illness
Keywords: Intensive Care Unit
Peripheral Venous Access
Landmark approach
Near-infrared light device
PIVC
Lead sponsor: Centre Hospitalier Régional d'Orléans
Sponsor class: OTHER
First posted: 2024-01-31
Enrollment: 380
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled multicenter trial Ratio 1:1
Primary purpose: OTHER

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Success rate on the first attempt of PIVC in ICU using NILD
timeFrame: Baseline
Secondary outcomes:
measure: number of attempts before successful PIVC
timeFrame: Baseline
measure: occurrence of local complications
timeFrame: Day 7
measure: success rate of PIVC according to nurses's experience
timeFrame: Baseline
measure: success rate of PIVC in patients considered with anticipated difficult intravenous access
timeFrame: Baseline
measure: PIVC insertion time
timeFrame: Baseline
measure: pain levels
timeFrame: Baseline
Other outcomes:
Locations:
city: Chartres
country: France
facility: CH de Chartres
city: Le Mans
country: France
facility: CH Le Mans
city: Orléans
country: France
facility: CHU Orléans
city: Tours
country: France
facility: CHU de Tours
Study officials:
affiliation: CHU Orléans
name: Aude FERRIER
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.