Novel Device for Ultrasound-guided Pediatric Vessel Cannulations

Not Applicable

• Conditions: Clinical Procedures Which Require Vessel Cannulations in Pediatric Patients
• Interventions: Device: SCENERGY

• Registration Number: NCT04039490
• Lead Sponsor: Clear Guide Medical

Brief 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.

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.

Study Timeline

• Status Verified: 2019-07
• Study First Submitted: 2019-07-29
• Study First Submitted QC: 2019-07-29
• Last Update Submitted: 2019-07-29
• Study First Posted: 2019-07-31
• Last Update Posted: 2019-07-31
• Study Start: 2020-09
• Primary Completion: 2021-08
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• any pediatric patient scheduled for a vessel cannulation at CNMC

Exclusion Criteria

• none

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SCENERGY-guided Pediatric Vessel Cannulation	SCENERGY	The addition of the SCENERGY guidance combined with the ultrasound for pediatric vessel cannulations.

Primary Outcome Measures

Name	Time	Method
Successful first-attempt vessel cannulation	1 hour	Test if the vessel cannulation was successful with only 1 attempt --needle puncture--to reach the vessel

Secondary Outcome Measures

Name	Time	Method
Non-IR Personnel Successfully Cannulate Pediatric Patients	1 hour	Test if non-specialists can learn to successfully cannulate pediatric patients with only 1 needle puncture.
Point-of-Care Successful Cannulation	1 hour	Test whether the SCENERGY makes possible successful pediatric vessel cannulations at patient's point of care location.

Trial Locations

Locations (1)

Children's National Medical Center; 🇺🇸 Washington, District of Columbia, United States