Comparison of Success Rates of Femoral Artery Catheterization

Not Applicable

Completed

• Conditions: Sepsis; Pulmonary Disease; Electrolyte Disorder; Metabolic Disease
• Interventions: Procedure: Femoral artery catheterization

• Registration Number: NCT02986542
• Lead Sponsor: Kahramanmaras Sutcu Imam University

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

Study Timeline

• Study First Submitted: 2016-11-18
• Study Start: 2016-12
• Study First Submitted QC: 2016-12-05
• Study First Posted: 2016-12-08
• Primary Completion: 2018-03-25
• Status Verified: 2018-04
• Study Completion: 2018-04-02
• Last Update Submitted: 2018-04-02
• Last Update Posted: 2018-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
USG with the in-plane technique	Femoral artery catheterization	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
USG with the out-of-plane technique	Femoral artery catheterization	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

Primary Outcome Measures

Name	Time	Method
Femoral artery catheterization puncture duration	1 - 5 minutes

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Kahramanmaraş Sütçü Imam Üniversity; 🇹🇷 Kahramanmaraş, Türkiye, Turkey