Novel Device for Ultrasound-guided Pediatric Vessel Cannulations

Study Overview
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Brief Summary
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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
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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.

Official Title
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Novel Device for Ultrasound-guided Pediatric Vessel Cannulations

Conditions
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Clinical Procedures Which Require Vessel Cannulations in Pediatric Patients

Intervention / Treatment
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* Device: SCENERGY


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: any pediatric patient scheduled for a vessel cannulation at CNMC Exclusion Criteria: none

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: two-arm study, comparing ultrasound-only pediatric vessel cannulations versus SCENERGY-guided pediatric vessel cannulations
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Ultrasound-only Pediatric Vessel Cannulation<br>The standard of care for vessel cannulation currently employed at CNMC | |
| Experimental: SCENERGY-guided Pediatric Vessel Cannulation<br>The addition of the SCENERGY guidance combined with the ultrasound for pediatric vessel cannulations. | Device: SCENERGY<br>* Use of the SCENERGY guidance device in conjunction with ultrasound to guide needles for pediatric vessel cannulations<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pediatrics, vessel cannulations, ultrasound-guided