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.

Study Overview

• Status: Unknown
• Conditions: Clinical Procedures Which Require Vessel Cannulations in Pediatric Patients
• Intervention / Treatment: Device: SCENERGY

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dorothee Heisenberg, PhD; Phone Number: 4435703835; Email: heisenberg@clearguidemedical.com
• Study Contact Backup: Name: Kevin Cleary, PhD; Phone Number: 202-476-3809; Email: KCleary@childrensnational.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 17 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• any pediatric patient scheduled for a vessel cannulation at CNMC

Exclusion Criteria:

• none

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	Test whether the SCENERGY makes possible successful pediatric vessel cannulations at patient's point of care location.	1 hour

Collaborators and Investigators

• Sponsor: Clear Guide Medical
• Collaborators: National Institutes of Health (NIH); Children's National Research Institute

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): September 1, 2020
• Primary Completion (ANTICIPATED): August 1, 2021
• Study Completion (ANTICIPATED): December 1, 2021

Study Registration Dates

• First Submitted: July 29, 2019
• First Submitted That Met QC Criteria: July 29, 2019
• First Posted (ACTUAL): July 31, 2019

Study Record Updates

• Last Update Posted (ACTUAL): July 31, 2019
• Last Update Submitted That Met QC Criteria: July 29, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: pediatrics; ultrasound-guided; vessel cannulations
• Other Study ID Numbers: CNMC Ph II Trial

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes