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

NCT05992246 | Completed DMC

• 1 other identifier: Pediatric Fluid Responsiveness
• Study Type: observational
• Target: 85
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pediatric ALL; Fluid Overload

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

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.

Eligibility Criteria

• Age: 2 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Faculty of medicine, Tanta university

Tanta, El Gharbyia, 31111, Egypt

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Edema

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• sameh Fathi, MD

  tanta university, faculty of medicine

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Study Record Dates

• First Submitted: August 8, 2023
• First Posted: August 15, 2023
• Study Start: August 20, 2023
• Primary Completion: December 30, 2024
• Study Completion: January 30, 2025
• Last Updated: February 4, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)