Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| Children's National Research Institute | OTHER |
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ultrasound-only Pediatric Vessel Cannulation | No Intervention | The standard of care for vessel cannulation currently employed at CNMC | |
| SCENERGY-guided Pediatric Vessel Cannulation | Experimental | The addition of the SCENERGY guidance combined with the ultrasound for pediatric vessel cannulations. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SCENERGY | Device | Use of the SCENERGY guidance device in conjunction with ultrasound to guide needles for pediatric vessel cannulations |
|
| Measure | Description | Time Frame |
|---|---|---|
| Successful first-attempt vessel cannulation | Test if the vessel cannulation was successful with only 1 attempt --needle puncture--to reach the vessel | 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Non-IR Personnel Successfully Cannulate Pediatric Patients | Test if non-specialists can learn to successfully cannulate pediatric patients with only 1 needle puncture. | 1 hour |
| Point-of-Care Successful Cannulation |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dorothee Heisenberg, PhD | Contact | 4435703835 | heisenberg@clearguidemedical.com | |
| Kevin Cleary, PhD | Contact | 202-476-3809 | KCleary@childrensnational.org |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's National Medical Center | Recruiting | Washington D.C. | District of Columbia | 20910 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
two-arm study, comparing ultrasound-only pediatric vessel cannulations versus SCENERGY-guided pediatric vessel cannulations
Not provided
Not provided
Because the SCENERGY is an attachment to the ultrasound probe, it cannot be masked.
Not provided
Test whether the SCENERGY makes possible successful pediatric vessel cannulations at patient's point of care location.
| 1 hour |