Difficult Intravenous Access in Pediatric Patients: Paramedical Care Using Ultrasound Guidance
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: peripheral intravenous catheterization performed with ultrasound guidance by a trained nurse.
- Who it may be relevant to
- Registry conditions: Catheter Related Complication. Basic parameters: 1 months — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Difficult Venous Access in Pediatric Patients: Paramedical Care Using Ultrasound Guidance
Overview
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).
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.
Interventions
- 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
Primary outcome measures
- Number of Participants with success at first intravenous catheter insertion attempt [Time frame: Day 0]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
France · 1 center
- Chu Reims — Reims
Identifiers
NCT: NCT06465121 · PP24044*