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CompletedNCT02986542Updated Apr 3, 2018

Comparison of Success Rates of Femoral Artery Catheterization

An interventional study of Femoral artery catheterization in Pulmonary Disease, Electrolyte Disorder and Metabolic Disease, sponsored by Kahramanmaras Sutcu Imam University. Completed at 1 site in Turkey. Open to participants aged 1 Day to 28 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-04-03.

Sponsored by Kahramanmaras Sutcu Imam University · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
65
Allocation
Randomized
Ages
1 Day to 28 Days
Sex
All
01

Study 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.

Read the 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
02

Conditions studied

  • Pulmonary Disease
  • Electrolyte Disorder
  • Metabolic Disease
  • Sepsis

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Keywords

  • newborns,femoral artery, catheterization
03

In context

Metabolic Diseases

997 studies on the registry are indexed under Metabolic Diseases; 234 are open to participants now.

This study's enrollment of 65 is above the median of 48 across 670 interventional studies indexed under Metabolic Diseases.

Browse Metabolic Diseases studies →

Lead sponsor

Kahramanmaras Sutcu Imam University is the lead sponsor of 192 studies on the registry; 40 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Day to 28 Days
Sexes eligible
All
Accepts 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

Exclusion Criteria:

  1. Local infection
  2. Coagulopathy
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
65 participants (actual)

Study arms

  • Active comparator
    USG with the in-plane technique

    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

    Procedure: Femoral artery catheterization

  • Active comparator
    USG with the out-of-plane technique

    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

    Procedure: Femoral artery catheterization

Interventions

  • ProcedureFemoral artery catheterization

    The intervention will be performed by a single experienced individual.

06

What researchers measure

Primary outcomes

  1. Femoral artery catheterization puncture duration

    Time frame: 1 - 5 minutes

Secondary outcomes

  1. Number of Attempts

    Time frame: 5 minutes

  2. Rate of Success of First Attempt

    Time frame: 1 - 5 minutes

  3. Distance of femoral artery to skin

    Distance of femoral artery to skin

    Time frame: 1 - 5 minutes

  4. Distance of femoral artery to inguinal ligament

    Time frame: 1 - 5 minutes

  5. Femoral artery diameter

    Time frame: 1 - 5 minutes

  6. Complications developing during the procedure

    Time frame: 24 hour

07

Study locations

1 site
  • Kahramanmaraş Sütçü Imam Üniversity
    Kahramanmaraş, Türkiye 46000, Turkey
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 3, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02986542
Lead sponsor
Kahramanmaras Sutcu Imam University
Responsible party
Ömer Faruk Boran (Assistant Professor, Kahramanmaras Sutcu Imam University) — Principal investigator
First posted
Dec 8, 2016
Start date
Dec 2016
Primary completion
Mar 25, 2018
Completion
Apr 2, 2018
Last update
Apr 3, 2018

Study contacts

Ömer Faruk Boran
study chair · Kahramanmaraş Üniversitesi

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.

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