Comparison of Success Rates of Femoral Artery Catheterization

Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02986542
• Other study ID #: 255
• Status: Completed
• Phase: N/A
• First received: November 18, 2016
• Last updated: April 2, 2018
• Start date: December 2016
• Est. completion date: April 2, 2018

Study information

• Verified date: April 2018
• Source: Kahramanmaras Sutcu Imam University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: April 2, 2018
• Est. primary completion date: March 25, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 28 Days

Eligibility

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

Related Conditions & MeSH terms

• Electrolyte Disorder
• Lung Diseases
• Metabolic Disease
• Metabolic Diseases
• Pulmonary Disease
• Sepsis

Intervention

Procedure:
• Femoral artery catheterization
The intervention will be performed by a single experienced individual.

Locations

Country	Name	City	State
Turkey	Kahramanmaras Sütçü Imam Üniversity	Kahramanmaras	Türkiye

Sponsors (1)

Lead Sponsor	Collaborator
Kahramanmaras Sutcu Imam University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Femoral artery catheterization puncture duration		1 - 5 minutes
Secondary	Number of Attempts		5 minutes
Secondary	Rate of Success of First Attempt		1 - 5 minutes
Secondary	Distance of femoral artery to skin	Distance of femoral artery to skin	1 - 5 minutes
Secondary	Distance of femoral artery to inguinal ligament		1 - 5 minutes
Secondary	Femoral artery diameter		1 - 5 minutes
Secondary	Complications developing during the procedure		24 hour