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Comparison of Success Rates of Femoral Artery Catheterization

Primary Purpose

Pulmonary Disease, Electrolyte Disorder, Metabolic Disease

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Femoral artery catheterization
Sponsored by
Kahramanmaras Sutcu Imam University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Pulmonary Disease focused on measuring newborns,femoral artery, catheterization

Eligibility Criteria

1 Day - 28 Days (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Kahramanmaraş Sütçü Imam Üniversity

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

USG with the in-plane technique

USG with the out-of-plane technique

Arm Description

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

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

Outcomes

Primary Outcome Measures

Femoral artery catheterization puncture duration

Secondary Outcome Measures

Number of Attempts
Rate of Success of First Attempt
Distance of femoral artery to skin
Distance of femoral artery to skin
Distance of femoral artery to inguinal ligament
Femoral artery diameter
Complications developing during the procedure

Full Information

First Posted
November 18, 2016
Last Updated
April 2, 2018
Sponsor
Kahramanmaras Sutcu Imam University
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1. Study Identification

Unique Protocol Identification Number
NCT02986542
Brief Title
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

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
December 2016 (undefined)
Primary Completion Date
March 25, 2018 (Actual)
Study Completion Date
April 2, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kahramanmaras Sutcu Imam University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 Local infection 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Electrolyte Disorder, Metabolic Disease, Sepsis
Keywords
newborns,femoral artery, catheterization

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
USG with the in-plane technique
Arm Type
Active Comparator
Arm Description
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
Arm Title
USG with the out-of-plane technique
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Femoral artery catheterization
Intervention Description
The intervention will be performed by a single experienced individual.
Primary Outcome Measure Information:
Title
Femoral artery catheterization puncture duration
Time Frame
1 - 5 minutes
Secondary Outcome Measure Information:
Title
Number of Attempts
Time Frame
5 minutes
Title
Rate of Success of First Attempt
Time Frame
1 - 5 minutes
Title
Distance of femoral artery to skin
Description
Distance of femoral artery to skin
Time Frame
1 - 5 minutes
Title
Distance of femoral artery to inguinal ligament
Time Frame
1 - 5 minutes
Title
Femoral artery diameter
Time Frame
1 - 5 minutes
Title
Complications developing during the procedure
Time Frame
24 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
28 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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: Local infection Coagulopathy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ömer Faruk Boran
Organizational Affiliation
Kahramanmaraş Üniversitesi
Official's Role
Study Chair
Facility Information:
Facility Name
Kahramanmaraş Sütçü Imam Üniversity
City
Kahramanmaraş
State/Province
Türkiye
ZIP/Postal Code
46000
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Comparison of Success Rates of Femoral Artery Catheterization

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