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

February 3, 2025 updated by: tarek abdel hay mostafa, Tanta University

The Validity of 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Observational

Enrollment (Actual)

85

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • El Gharbyia
      • Tanta, El Gharbyia, Egypt, 31111
        • Faculty of medicine, Tanta University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Preoperative children with ASA physical status 1-2, 2-10 years of age scheduled for elective surgery with signs of moderate to severe dehydration for assessment of fluid status just before induction of general anaesthesia

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
immediate preoperative period before the induction of general anesthesia

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Investigators

  • Study Director: sameh Fathi, MD, tanta university, faculty of medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 20, 2023

Primary Completion (Actual)

December 30, 2024

Study Completion (Actual)

January 30, 2025

Study Registration Dates

First Submitted

August 8, 2023

First Submitted That Met QC Criteria

August 8, 2023

First Posted (Actual)

August 15, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 3, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • Pediatric Fluid Responsiveness

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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