Novel Device for Ultrasound-guided Pediatric Vessel Cannulations

Clear Guide Medical

Status: Enrolling

Conditions: Clinical Procedures Which Require Vessel Cannulations in Pediatric Patients

Treatments: Device: SCENERGY

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT04039490

CNMC Ph II Trial

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 1 month to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• any pediatric patient scheduled for a vessel cannulation at CNMC

Exclusion criteria

• none

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Ultrasound-only Pediatric Vessel Cannulation

No Intervention group

Description:

The standard of care for vessel cannulation currently employed at CNMC

SCENERGY-guided Pediatric Vessel Cannulation

Experimental group

Description:

The addition of the SCENERGY guidance combined with the ultrasound for pediatric vessel cannulations.

Treatment:

Device: SCENERGY