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

Phase

N/A

Condition

N/A

Treatment

peripheral intravenous catheterization performed with ultrasound guidance by a trained nurse

Clinical Study ID

NCT06465121

PP24044*

Ages 1-18
All Genders

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 Criteria

Inclusion

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 theconsent of the holder(s) of parental authority has been obtained
affiliated to a social security scheme

Exclusion

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 ofthe medical team

Study Design

peripheral intravenous catheterization performed with ultrasound guidance by a trained nurse

February 17, 2026

September 30, 2027

Study Description

Venipunctures are very common in hospitalized patients. Obtaining venous access is more difficult in the pediatric population, particularly due to the smaller size of the vessels and the more difficult cooperation of patients. Traditional method for inserting intravenous catheter access requires knowledge of vascular anatomy to estimate the location of the target vein and requires visualization or palpation of the vein. The success rate for peripheral intravenous catheterization in pediatric patients is approximately 60% after one attempt and 90% after four. Delays in intravenous access can result in significant morbidity and mortality. Thus, alternative methods should be considered to improve pediatric access sites.

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. This could also have an impact on the frequency of the main associated adverse events.