Ireland
--:--IST
Recruiting Not applicable

Difficult Intravenous Access in Pediatric Patients: Paramedical Care Using Ultrasound Guidance

NCT06465121 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2026-02-17
Last updated
2026-02-20

Condition(s) studied

Catheter Related Complication

Investigational drug(s) / intervention(s)

peripheral intravenous catheterization performed with ultrasound guidance by a trained nurse

peripheral intravenous catheterization performed with ultrasound guidance by a trained nurse: Intravenous catheterization using ultrasound-guidance to allow real-time visualization of target veins in pediatric patients with difficult intravenous access

Study summary

Obtaining intravenous access is difficult in the pediatric population. Ultrasound-guidance allows real-time visualization of target veins which are invisible and impalpable. We hypothesize that the use of ultrasound by a trained nurse team would improve the success rate of peripheral intravenous catheter insertion in pediatric patients with difficult intravenous access, compared to palpation of the vein alone.

For this study, when peripheral intravenous catheterization will be indicated in one of the participating pediatric services for an eligible patient, state-certified nurse investigators, trained in ultrasound guidance, will be contacted. After verification of eligibility criteria and all informed consents obtained, one of the investigators will randomize the patient in one of the 2 treatment groups under study: peripheral intravenous catheterization by visualization and palpation of the vein alone (standard of care) or by ultrasound guidance performed by a trained nurse.

Several outcomes will be measured and compared between the 2 groups (e.g. successful insertion of intravenous catheter, pain, adverse events).

Eligibility

Sex
ALL
Min age
1 Month
Max age
18 Years
Healthy volunteers
No
Inclusion Criteria : * age ≥ 1 month and \< 18 years * intravenous catheter insertion indicated for hospital care * DIVA (Difficult Intravenous Access Scale) score ≥ 4 * hospitalized in one of the pediatric departments of the Reims University Hospital * who agree to participate in the study (if old enough to understand) and for whom the consent of the holder(s) of parental authority has been obtained * affiliated to a social security scheme Exclusion Criteria: * Newborns (\< 1 month) and premature babies hospitalized in neonatal intensive care, neonatology and maternity units * Known vascular pathology * Hemodialysis with arteriovenous fistula * Unstable hemodynamic and/or respiratory clinical state according to the judgment of the medical team

Primary outcome measure(s)

  • Number of Participants with success at first intravenous catheter insertion attempt — Day 0
    Success at first attempt of intravenous catheter insertion with ultrasound-guidance compared to standard of care for pediatric patients with difficult venous access

Trial sites (1)

FacilityCityRegionStatus
Chu Reims Reims France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06465121 on ClinicalTrials.gov ↗ ← All trials in France