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Clinical Trials/NCT04039490
NCT04039490
Unknown
Not Applicable

Novel Device for Ultrasound-guided Pediatric Vessel Cannulations

Clear Guide Medical1 site in 1 country60 target enrollmentSeptember 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Clinical Procedures Which Require Vessel Cannulations in Pediatric Patients
Sponsor
Clear Guide Medical
Enrollment
60
Locations
1
Primary Endpoint
Successful first-attempt vessel cannulation
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2020
End Date
December 2021
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Clear Guide Medical
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • any pediatric patient scheduled for a vessel cannulation at CNMC

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Successful first-attempt vessel cannulation

Time Frame: 1 hour

Test if the vessel cannulation was successful with only 1 attempt --needle puncture--to reach the vessel

Secondary Outcomes

  • Non-IR Personnel Successfully Cannulate Pediatric Patients(1 hour)
  • Point-of-Care Successful Cannulation(1 hour)

Study Sites (1)

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