Novel Device for Ultrasound-guided Pediatric Vessel Cannulations

Clinical Procedures Which Require Vessel Cannulations in Pediatric Patients Clinical Trial

Official title:

Novel Device for Ultrasound-guided Pediatric Vessel Cannulations

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04039490
• Other study ID #: CNMC Ph II Trial
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2020
• Est. completion date: December 2021

Study information

• Verified date: July 2019
• Source: Clear Guide Medical
• Contact: Dorothee Heisenberg, PhD
• Phone: 4435703835
• Email: heisenberg[@]clearguidemedical.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 2021
• Est. primary completion date: August 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 17 Years

Eligibility

Inclusion Criteria:

• any pediatric patient scheduled for a vessel cannulation at CNMC

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• Clinical Procedures Which Require Vessel Cannulations in Pediatric Patients

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Clear Guide Medical	Children's Research Institute, National Institutes of Health (NIH)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Successful first-attempt vessel cannulation	Test if the vessel cannulation was successful with only 1 attempt --needle puncture--to reach the vessel	1 hour
Secondary	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
Secondary	Point-of-Care Successful Cannulation	Test whether the SCENERGY makes possible successful pediatric vessel cannulations at patient's point of care location.	1 hour