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Completed

NCT Number: NCT05992246

The Ratio of Femoral Vein Diameter to Femoral Artery Diameter to Predict Fluid Responsiveness in Children

The hypothesis of the study will be that the ratio of femoral vein diameter to femoral artery diameter will have correlation with fluid status in pediatrics.

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Key information

About this study

Proper administration of intravenous fluids is an important part of treating circulatory failure in children and affects the clinical outcome of the management of the child's emergency. Giving a small amount of fluid will cause tissue hypoperfusion and worsen organ dysfunction and cause ischemia. On the other hand, excess fluid interferes with oxygen delivary, exacerbates treatment outcomes, increases complications, and extends both the length of the stay in intensive care and mortality. The use of bedside ultrasound by pediatric intensive care physicians has become so critical in recent years that it is now a component of physical examination in ICUs

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • children with American society of anaesthesiologist physical status 1-2
  • 2-10 years of age
  • scheduled for elective surgery
  • signs of moderate to severe dehydration

Exclusion criteria

  • Patients with mild dehydration.
  • Patients with history of significant comorbid conditions or previous laparotomy.
  • Congenital heart disease.
  • Heart failure.
  • Disorder of venous return like arteriovenous fistula, DVT or Varicose veins.
  • Increase intra-abdominal pressure.

Treatment and study plan

Ratio of Femoral Vein Diameter to Femoral Artery Diameter

Diagnostic Test

An ultrasound probe will be used to first scan the area of the upper thigh just below the inguinal ligament directing caudally seeking for the femoral vessels. The femoral artery and vein could be observed simultaneously. Under normal conditions, pulsation is an indication of the femoral artery, and its companion is the femoral vein. The mean femoral vein diameter and femoral vein diameter (3-5 diametral lines in different directions) will be measured during cough, crying, or performing the Valsalva maneuvers.

Primary outcomes

  1. Measurement of changes in the ratio of femoral vein diameter to femoral artery diameter

    Time frame: immediate preoperative period before the induction of general anesthesia

    Measurement of changes in the ratio of femoral vein diameter to femoral artery diameter before and after fluid challenge which will be defined as infusion of ringer lactate 10 ml/kg body weight over 20 min.

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

The Validity of the Ratio of Femoral Vein Diameter to Femoral Artery Diameter to Predict Fluid Responsiveness in Children

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Aug 15, 2023
Registry last updated
Feb 4, 2025

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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