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

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

ArmDescriptionAssigned 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.
  • Device: SCENERGY
    Use of the SCENERGY guidance device in conjunction with ultrasound to guide needles for pediatric vessel cannulations

Recruiting Locations

Children's National and nearby locations

Children's National Medical Center
Washington, District of Columbia 20910
Contact:
Karun Sharma, MD
301-565-8447
OPHS@childrensnational.org

More Details

NCT ID
NCT04039490
Status
Recruiting
Sponsor
Clear Guide Medical

Study Contact

Dorothee Heisenberg, PhD
4435703835
heisenberg@clearguidemedical.com

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.