NCT06465121 Difficult Intravenous Access in Pediatric Patients: Paramedical Care Using Ultrasound Guidance
| NCT ID | NCT06465121 |
| Status | Recruiting |
| Phase | — |
| Sponsor | CHU de Reims |
| Condition | Catheter Related Complication |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2026-02-17 |
| Primary Completion | 2027-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2026-02-17 with a primary completion date of 2027-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06465121 clinical trial?
This trial is open to participants of all sexes, aged 1 Month or older, up to 18 Years, studying Catheter Related Complication. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06465121 currently recruiting?
Yes, NCT06465121 is actively recruiting participants. Contact the research team at cindycollet88@gmail.com for enrollment information.
Where is the NCT06465121 trial being conducted?
This trial is being conducted at Reims, France.
Who is sponsoring the NCT06465121 clinical trial?
NCT06465121 is sponsored by CHU de Reims. The trial plans to enroll 120 participants.