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

NCT06465121 | Recruiting

• 1 other identifier: PP24044*
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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).

Conditions

Catheter Related Complication

Outcome Measures

Primary Outcomes (1)

• Number of Participants with success at first intravenous catheter insertion attempt

  Success at first attempt of intravenous catheter insertion with ultrasound-guidance compared to standard of care for pediatric patients with difficult venous access

  Day 0

Study Arms (2)

Ultrasound guidance

EXPERIMENTAL

peripheral intravenous catheterization performed with ultrasound guidance by a trained nurse

Procedure: peripheral intravenous catheterization performed with ultrasound guidance by a trained nurse

Standard of care

NO INTERVENTION

Peripheral intravenous catheterization by visualization and palpation of the vein alone

Interventions

peripheral intravenous catheterization performed with ultrasound guidance by a trained nurse PROCEDURE

Intravenous catheterization using ultrasound-guidance to allow real-time visualization of target veins in pediatric patients with difficult intravenous access

Ultrasound guidance

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• CHU de Reims: lead

Study Sites (1)

Chu Reims

Reims, 51092, France

RECRUITING

Central Study Contacts

Cindy COLLET

CONTACT

0326787878; cindycollet88@gmail.com

Caroline WOLFERT-CATTANEO

CONTACT

0326787878; carowolf@orange.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2024
• First Posted: June 18, 2024
• Study Start: February 17, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: February 20, 2026

Record last verified: 2026-02

Locations

FR (1)