Novel Device for Ultrasound-guided Pediatric Vessel Cannulations
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: SCENERGY.
- Who it may be relevant to
- Registry conditions: Clinical Procedures Which Require Vessel Cannulations in Pediatric Patients. Basic parameters: 1 months — 17 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
- United States
- 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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Overview
Clinical Trial to investigate whether the use of a novel device to be used in conjunction with ultrasound in pediatric vessel cannulations is superior to ultrasound-only pediatric vessel cannulations in terms of number of cannulation attempts.
Detailed description
Use of needle guidance plus ultrasound imaging for CVC placement in the pediatric high-risk population may facilitate the procedure with a single needle pass and decrease the incidence of adverse effects by minimizing additional needle passes. This study will compare the use of ultrasound-only guidance with the Clear Guide SCENERGY guidance in terms of successful first-attempt vessel cannulations such as internal jugular and fermoral artery access. The question is whether it is possible to make ultrasound-guided pediatric vascular access less technically challenging in order to improve adoption and utilization leading to decreased iatrogenic complications and improved patient safety.
Interventions
- Device SCENERGY
Use of the SCENERGY guidance device in conjunction with ultrasound to guide needles for pediatric vessel cannulations
Primary outcome measures
- Successful first-attempt vessel cannulation [Time frame: 1 hour]
Secondary outcome measures (2)
- Non-IR Personnel Successfully Cannulate Pediatric Patients [Time frame: 1 hour]
- Point-of-Care Successful Cannulation [Time frame: 1 hour]
Eligibility criteria
Inclusion criteria
- any pediatric patient scheduled for a vessel cannulation at CNMC
Exclusion criteria
- none
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
United States · 1 center
- Children's National Medical Center — Washington D.C.
Identifiers
NCT: NCT04039490 · CNMC Ph II Trial