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

Sponsor

Tanta University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05992246

Collaborator

(none)

Enrollment

Location

11.4

Anticipated Duration (Months)

7.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pediatric ALL Fluid Overload	Diagnostic Test: Ratio of Femoral Vein Diameter to Femoral Artery Diameter

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 Design

Study Type:

Observational

Anticipated Enrollment :

85 participants

Observational Model:

Case-Crossover

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Aug 20, 2023

Anticipated Primary Completion Date :

Jul 1, 2024

Anticipated Study Completion Date :

Aug 1, 2024

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 10 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of medicine, Tanta university	Tanta	El Gharbyia	Egypt	31111

Sponsors and Collaborators

Tanta University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

tarek abdel hay mostafa, principle investigator, Tanta University

ClinicalTrials.gov Identifier:

NCT05992246

Other Study ID Numbers:

Pediatric Fluid Responsiveness

First Posted:

Aug 15, 2023

Last Update Posted:

Aug 15, 2023

Last Verified:

Aug 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Aug 15, 2023