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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-18
SponsorCHU de Reims

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

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

    Procedure/Surgery

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

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Ultrasound guidanceExperimental treatment 1 intervention
Group B: Standard of careNo intervention 0 interventions

Trial outcomes

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

Time frame
Day 0

Secondary outcomes

Other outcomes

Sponsors and contacts

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