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

Pediatric ALL Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05992246
• Other study ID #: Pediatric Fluid Responsiveness
• Status: Recruiting
• Start date: August 20, 2023
• Est. completion date: August 2024

Study information

• Verified date: November 2023
• Source: Tanta University
• Contact: tarek A Mostafa, MD
• Phone: +201207416231
• Email: dr.tarek311[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 85
• Est. completion date: August 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 10 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fluid Overload
• Pediatric ALL

Intervention

Diagnostic Test:
• Ratio of Femoral Vein Diameter to Femoral Artery Diameter
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.

Locations

Country	Name	City	State
Egypt	Faculty of medicine, Tanta university	Tanta	El Gharbyia

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of changes in the ratio of femoral vein diameter to femoral artery diameter	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