Clinical Procedures Which Require Vessel Cannulations in Pediatric Patients
Conditions
Keywords
pediatrics, vessel cannulations, ultrasound-guided
Brief summary
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
DEVICESCENERGY
Use of the SCENERGY guidance device in conjunction with ultrasound to guide needles for pediatric vessel cannulations
Sponsors
National Institutes of Health (NIH)
Children's National Research Institute
Clear Guide Medical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Masking description
Because the SCENERGY is an attachment to the ultrasound probe, it cannot be masked.
Intervention model description
two-arm study, comparing ultrasound-only pediatric vessel cannulations versus SCENERGY-guided pediatric vessel cannulations
Eligibility
Sex/Gender
ALL
Age
1 Months to 17 Years
Healthy volunteers
No
Inclusion criteria
* any pediatric patient scheduled for a vessel cannulation at CNMC
Exclusion criteria
* none
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Successful first-attempt vessel cannulation | 1 hour | Test if the vessel cannulation was successful with only 1 attempt --needle puncture--to reach the vessel |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Non-IR Personnel Successfully Cannulate Pediatric Patients | 1 hour | Test if non-specialists can learn to successfully cannulate pediatric patients with only 1 needle puncture. |
| Point-of-Care Successful Cannulation | 1 hour | Test whether the SCENERGY makes possible successful pediatric vessel cannulations at patient's point of care location. |
Countries
United States
Contacts
Primary ContactDorothee Heisenberg, PhD
Backup ContactKevin Cleary, PhD
Outcome results
None listed