Clinical trial NCT02986542: Comparison of Success Rates of Femoral Artery Catheterization
Official title: Comparison of Success Rates of Femoral Artery Catheterization for Newborns With In-plane and Out-of-plane Ultrasonography Techniques
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Disease
Electrolyte Disorder
Metabolic Disease
Sepsis
Keywords: newborns,femoral artery, catheterization
Lead sponsor: Kahramanmaras Sutcu Imam University
Sponsor class: OTHER
First posted: 2016-12-08
Enrollment: 65
Sex: ALL
Minimum age (years): 1
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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: 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

1. Local infection
2. 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

Eligibility criteria: 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:

1. Local infection
2. Coagulopathy

Primary outcomes:
measure: Femoral artery catheterization puncture duration
timeFrame: 1 - 5 minutes
Secondary outcomes:
measure: Number of Attempts
timeFrame: 5 minutes
measure: Rate of Success of First Attempt
timeFrame: 1 - 5 minutes
measure: Distance of femoral artery to skin
timeFrame: 1 - 5 minutes
measure: Distance of femoral artery to inguinal ligament
timeFrame: 1 - 5 minutes
measure: Femoral artery diameter
timeFrame: 1 - 5 minutes
measure: Complications developing during the procedure
timeFrame: 24 hour
Other outcomes:
Locations:
city: Kahramanmaraş
country: Turkey
facility: Kahramanmaraş Sütçü Imam Üniversity
state: Türkiye
Study officials:
affiliation: Kahramanmaraş Üniversitesi
name: Ömer Faruk Boran
role: STUDY_CHAIR
References: