Children's National Medical Center
Washington D.C., District of Columbia, 20910, United States
Location status: Recruiting
Recruiting
NCT Number: NCT04039490
Novel Device for Ultrasound-guided Pediatric Vessel Cannulations
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.
Recruiting
Interested in participating?
Request InfoKey information
Age range
1 month–17 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- any pediatric patient scheduled for a vessel cannulation at CNMC
Exclusion criteria
- none
Treatment and study plan
SCENERGY
DeviceUse of the SCENERGY guidance device in conjunction with ultrasound to guide needles for pediatric vessel cannulations
Primary outcomes
-
Successful first-attempt vessel cannulation
Time frame: 1 hour
Test if the vessel cannulation was successful with only 1 attempt --needle puncture--to reach the vessel
Secondary outcomes
-
Non-IR Personnel Successfully Cannulate Pediatric Patients
Time frame: 1 hour
Test if non-specialists can learn to successfully cannulate pediatric patients with only 1 needle puncture.
-
Point-of-Care Successful Cannulation
Time frame: 1 hour
Test whether the SCENERGY makes possible successful pediatric vessel cannulations at patient's point of care location.
Study contacts
Contact information is provided by the study sponsor or research team.
Dorothee Heisenberg, PhD
CONTACT
Kevin Cleary, PhD
CONTACT
Sponsors and collaborators
Lead sponsor
Clear Guide Medical
Industry
Collaborators
- Children's National Research Institute
- National Institutes of Health (NIH)
Registry information
Important dates
- Study start
- 2024
- Primary completion
- 2025
- Study completion
- 2025
- First posted
- Jul 31, 2019
- Registry last updated
- Sep 26, 2024
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.