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Comparison of Success Rates of Femoral Artery Catheterization

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02986542
Enrollment
65
Registered
2016-12-08
Start date
2016-12-31
Completion date
2018-04-02
Last updated
2018-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Electrolyte Disorder, Metabolic Disease, Pulmonary Disease, Sepsis

Keywords

newborns,femoral artery, catheterization

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

Interventions

The intervention will be performed by a single experienced individual.

Sponsors

Kahramanmaras Sutcu Imam University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
1 Days to 28 Days
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Femoral artery catheterization puncture duration1 - 5 minutes

Secondary

MeasureTime frameDescription
Rate of Success of First Attempt1 - 5 minutes
Distance of femoral artery to skin1 - 5 minutesDistance of femoral artery to skin
Number of Attempts5 minutes
Femoral artery diameter1 - 5 minutes
Complications developing during the procedure24 hour
Distance of femoral artery to inguinal ligament1 - 5 minutes

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026