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Completed

NCT Number: NCT02986542

Comparison of Success Rates of Femoral Artery Catheterization

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.

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Key information

Conditions

Pulmonary Disease Electrolyte Disorder Infections Inflammation Lung Diseases Metabolic Disease Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Sepsis Systemic Inflammatory Response Syndrome

Age range

1 day–28 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kahramanmaraş Sütçü Imam Üniversity

Kahramanmaraş, Türkiye, 46000, Turkey (Türkiye)

About this study

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)
  • 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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Femoral artery catheterization

Procedure

The intervention will be performed by a single experienced individual.

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

    Time frame: 1 - 5 minutes

    Distance of femoral artery to skin

  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

Sponsors and collaborators

Lead sponsor

Kahramanmaras Sutcu Imam University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Dec 8, 2016
Registry last updated
Apr 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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