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

NCT ID: NCT05992246

Last Updated: 2025-02-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

85 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-08-20

Study Completion Date

2025-01-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pediatric ALL Fluid Overload

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

2 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Tanta University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

tarek abdel hay mostafa

principle investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

sameh Fathi, MD

Role: STUDY_DIRECTOR

tanta university, faculty of medicine

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Faculty of medicine, Tanta university

Tanta, El Gharbyia, Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Pediatric Fluid Responsiveness

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.