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NCT Number: NCT06465121

Difficult Intravenous 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).

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Key information

Age range

1 month–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chu Reims

Reims, 51092, France

Location status: Recruiting

Location contact

Damien JOLLY, Pr.

CONTACT

[email protected]

326788472 ext. 33

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Number of Participants with success at first intravenous catheter insertion attempt

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Caroline WOLFERT-CATTANEO

CONTACT

[email protected]

0326787878 ext. 0033

Cindy COLLET

CONTACT

[email protected]

0326787878 ext. 0033

Sponsors and collaborators

Lead sponsor

CHU de Reims

Other

Registry information

Official study title

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

Acronym: VVParamECHO

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 18, 2024
Registry last updated
Feb 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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