Clinical Trials Directory

Trials / Completed

CompletedNCT02986542

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
Phase
N/A
Study type
Interventional
Enrollment
65 (actual)
Sponsor
Kahramanmaras Sutcu Imam University · Academic / Other
Sex
All
Age
1 Day – 28 Days
Healthy volunteers
Accepted

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

Conditions

Interventions

TypeNameDescription
PROCEDUREFemoral artery catheterizationThe intervention will be performed by a single experienced individual.

Timeline

Start date
2016-12-01
Primary completion
2018-03-25
Completion
2018-04-02
First posted
2016-12-08
Last updated
2018-04-03

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT02986542. Inclusion in this directory is not an endorsement.