Comparison of Success Rates of Femoral Artery Catheterization

Study Overview
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Brief Summary
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The use of USI has eased practical application of interventional procedures, and reduced complications and procedure durations. For vascular interventions with ultrasound imaging, short- or long-section imaging of vascular structures is performed. Both techniques have their own advantages and disadvantages. This study aims to compare the success rates of femoral artery catheterization using both imaging techniques.

Detailed Description
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The research will include newborns undergoing open heart surgery and patients requiring arterial monitoring in the neonatal intensive care unit. Eighty patients requiring femoral artery cannulation will be randomized with the closed envelope method and separated into two groups as USI with the in-plane technique (Group A) and USI with the out-of-plane technique (Group B). The intervention will be performed by a single experienced individual. The preparation duration, puncture duration, number of punctures, number of unsuccessful arterial punctures, development of hematoma and other complications will be recorded and the groups will be compared. If there are 3 unsuccessful attempts the procedure will be ended.1. Patients undergoing KVC surgery and patients requiring arterial catheterization in the neonatal intensive care unit (cases with pulmonary disease, electrolyte disorders, metabolic disease, or sepsis requiring frequent blood sampling) EXCLUSION CRITERIA FOR STUDY VOLUNTEERS Local infection Coagulopathy CLINICAL END-POINTS (MEASURED VARIABLES) 1. Distance of femoral artery to skin, distance of femoral artery to inguinal ligament, femoral artery diameter, femoral artery and vein location properties 2. Preparation duration, number of punctures, complications developing during the procedure

Official Title
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Comparison of Success Rates of Femoral Artery Catheterization for Newborns With In-plane and Out-of-plane Ultrasonography Techniques

Conditions
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Pulmonary Disease, Electrolyte Disorder, Metabolic Disease, Sepsis

Intervention / Treatment
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* Procedure: Femoral artery catheterization


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing KVC surgery and patients requiring arterial catheterization in the neonatal intensive care unit (cases with pulmonary disease, electrolyte disorders, metabolic disease, or sepsis requiring frequent blood sampling Exclusion Criteria: Local infection Coagulopathy

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 28 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: USG with the in-plane technique<br>Intervention: Femoral artery catheterization under USG guidance with the in-plane technique.Patients will have their femoral arterial lines inserted under the guidance of USG. The ultrasound equipment used is LOGIQ e GE medical system(China) CO.LTD | Procedure: Femoral artery catheterization<br>* The intervention will be performed by a single experienced individual.<br>|
| Active Comparator: USG with the out-of-plane technique<br>Intervention: Under USG guidance femoral artery catheterization will be done with the probe placed for the out-of-plane technique. The ultrasound equipment used is LOGIQ e GE medical system(China) CO.LTD | Procedure: Femoral artery catheterization<br>* The intervention will be performed by a single experienced individual.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Femoral artery catheterization puncture duration |  | 1 - 5 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Attempts |  | 5 minutes | 
| Rate of Success of First Attempt |  | 1 - 5 minutes | 
| Distance of femoral artery to skin | Distance of femoral artery to skin | 1 - 5 minutes | 
| Distance of femoral artery to inguinal ligament |  | 1 - 5 minutes | 
| Femoral artery diameter |  | 1 - 5 minutes | 
| Complications developing during the procedure |  | 24 hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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newborns,femoral artery, catheterization