Novel Device for Ultrasound-guided Pediatric Vessel Cannulations
Purpose
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.
Condition
- Clinical Procedures Which Require Vessel Cannulations in Pediatric Patients
Eligibility
- Eligible Ages
- Between 1 Month and 17 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- any pediatric patient scheduled for a vessel cannulation at CNMC
Exclusion Criteria
- none
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- two-arm study, comparing ultrasound-only pediatric vessel cannulations versus SCENERGY-guided pediatric vessel cannulations
- Primary Purpose
- Other
- Masking
- None (Open Label)
- Masking Description
- Because the SCENERGY is an attachment to the ultrasound probe, it cannot be masked.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
No Intervention Ultrasound-only Pediatric Vessel Cannulation |
The standard of care for vessel cannulation currently employed at CNMC |
|
|
Experimental SCENERGY-guided Pediatric Vessel Cannulation |
The addition of the SCENERGY guidance combined with the ultrasound for pediatric vessel cannulations. |
|
Recruiting Locations
Children's National and nearby locations
Washington, District of Columbia 20910
More Details
- NCT ID
- NCT04039490
- Status
- Recruiting
- Sponsor
- Clear Guide Medical
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.