Comparing two methods for inserting IV lines in critically ill patients
Near-Infrared Light Devices Versus Landmark Approach for Peripheral Venous Access in Intensive Care Unit: A Randomized Controlled Study
NA · Centre Hospitalier Régional d'Orléans · NCT06234293
This study is testing whether using a special light device can help doctors insert IV lines more successfully in critically ill patients who have swollen arms.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 380 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Régional d'Orléans (other) |
| Drugs / interventions | chemotherapy |
| Locations | 4 sites (Chartres and 3 other locations) |
| Trial ID | NCT06234293 on ClinicalTrials.gov |
What this trial studies
This multicenter randomized controlled study aims to evaluate the effectiveness of near-infrared light devices (NILD) versus the traditional landmark approach for peripheral intravenous cannulation (PIVC) in critically ill patients with upper limb edema. A total of 380 patients will be randomly assigned to either method, with randomization stratified by center and anticipated difficulty of venous access. The study will assess the success rate of PIVC attempts, with a maximum of five attempts allowed per method before considering the intervention a failure. The goal is to determine if NILD can improve the success of PIVC in patients who are challenging to access due to their condition.
Who should consider this trial
Good fit: Ideal candidates are critically ill patients aged 18 and older in the ICU who no longer require a deep venous catheter.
Not a fit: Patients with absolute contraindications for PIVC or those who are unable to provide consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the ability to establish IV access in critically ill patients, potentially reducing complications and improving patient care.
How similar studies have performed: While the use of near-infrared light devices has been explored in other settings, this specific application in the ICU for PIVC has not been extensively studied, making it a novel approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Chartres and 3 other locations
- CH de Chartres — Chartres, France (RECRUITING)
- CH Le Mans — Le Mans, France (RECRUITING)
- CHU Orléans — Orléans, France (RECRUITING)
- CHU de Tours — Tours, France (NOT_YET_RECRUITING)
Study contacts
- Principal investigator: Aude FERRIER — CHU Orléans
- Study coordinator: Aude FERRIER
- Email: aude.ferrier@chu-orleans.fr
- Phone: +33238744077
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Upper Limb Edema, Critical Illness, Intensive Care Unit, Peripheral Venous Access, Landmark approach, Near-infrared light device, PIVC