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

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

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).

Study Overview

• Status: Recruiting
• Conditions: Catheter Related Complication
• Intervention / Treatment: Procedure: peripheral intravenous catheterization performed with ultrasound guidance by a trained nurse

Detailed 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.

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).

Children will be followed for a maximum of 7 days or until discharge from hospitalization.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cindy COLLET; Phone Number: 0033 0326787878; Email: cindycollet88@gmail.com
• Study Contact Backup: Name: Caroline WOLFERT-CATTANEO; Phone Number: 0033 0326787878; Email: carowolf@orange.fr

Study Locations

• France
  • Reims, France, 51092
    • Recruiting
    • Chu Reims
    • Contact: Damien JOLLY, Pr.; Phone Number: 33 326788472; Email: djolly@chu-reims.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ultrasound guidance; peripheral intravenous catheterization performed with ultrasound guidance by a trained nurse	Procedure: 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
No Intervention: Standard of care; Peripheral intravenous catheterization by visualization and palpation of the vein alone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: CHU de Reims

Study record dates

Study Major Dates

• Study Start (Actual): February 17, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: June 12, 2024
• First Submitted That Met QC Criteria: June 17, 2024
• First Posted (Actual): June 18, 2024

Study Record Updates

• Last Update Posted (Actual): February 20, 2026
• Last Update Submitted That Met QC Criteria: February 18, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: PP24044*

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No