Non-invasive Assessment of the Current State of Hydration in Children by Ultrasound

Assessment of the Current State of Volume Status in Children by Ultrasound Measurement of Vena Cava Inferior and Vena Jugularis Interna Combined With Passive Leg Raise: a Pilot Study

Children with clinical signs of severe dehydration will be examined by ultrasound in a supine position during admission. Children aged between 1 and 15years will be divided into three weight groups: 10-20kg, 20-30kg, 30-50kg. Early after admission 1st measurement of diameters of vena cava inferior (VCImax, VCImin) during breathing cycles and diameters of both venae jugulares (VJI dx max, min, VJI sin max, min) before and after passive leg raise maneuver will be recorded. After a defined fluid infusion within 60 minutes, a second examination will be evaluated and compared with the first one. The investigators considered also echocardiography to measure CO changes however they wanted to make it as simple as it might be at emergency during the night shift without an experienced cardiologist.

Study Overview

• Status: Completed
• Conditions: Gastroenteritis; Diabetes Mellitus (Ketoacidosis)
• Intervention / Treatment: Procedure: Intravenous administration of fluids

Detailed Description

Only children admitted to the hospital with clinically detectable dehydration (weight loss, dry skin, sunken eyes, no tears) will be evaluated. Weight, noninvasive blood pressure measurement, pulse rate will be recorded. Measurements would be performed with an ultrasound probe with a low frequency (2-5 MHz), a curved array transducer will be used. In the supine position, the ultrasound probe will be placed in the substernal area, in the longitudinal and transversal plane, 1 cm caudal to the confluence of the hepatic veins, and it will be operated in M-mode. The largest (VCImax) and smallest (VCImin) diameters will be measured and the collapsibility index will be calculated (according to the formula: VCImax - VCI min / VCI max x100). Immediately after this examination measurement of the right VJImax, min and the left VJImax, min will be measured again in the supine position, then after passive leg raise (lifting the lower limbs 45st. for at least 1minute ) VJImax, min. and left VJImax, min will be measured. The collapsibility index for right and left VJI would be calculated according to the formula: VJImax - VJI min / VJI max x100. After a defined fluid infusion (20ml/kg, but the maximum volume will be limited to 500ml, this means that over 25kg weight we would apply not more than 500ml) within 60 minutes. A control examination of VCI, right VJI, and left VJI will be evaluated the same way as first and compared with the previous one.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Czechia
  • Moravian-Silesian Region
    • Ostrava, Moravian-Silesian Region, Czechia, 70852
      • University Hospital Ostrava

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 15 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• previously healthy children
• history and clinical signs of dehydration (gastroenteritis, diabetic ketoacidosis)

Exclusion Criteria:

• congenital heart diseases
• intestinal obstruction
• any signs of abdominal hypertension
• any illnesses known to affect the volume status

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Weight category 10-20kg; Pediatric patients with a weight of 10-20kg will be enrolled in this arm.	Procedure: Intravenous administration of fluids; Intravenous administration of fluids (20ml/kg, but the maximum volume will be limited up to 500ml) within 60 minutes.
Experimental: Weight category 20-30kg; Pediatric patients with a weight of 20-30kg will be enrolled in this arm.	Procedure: Intravenous administration of fluids; Intravenous administration of fluids (20ml/kg, but the maximum volume will be limited up to 500ml) within 60 minutes.
Experimental: Weight category 30-50kg; Pediatric patients with a weight of 30-50kg will be enrolled in this arm.	Procedure: Intravenous administration of fluids; Intravenous administration of fluids (20ml/kg, but the maximum volume will be limited up to 500ml) within 60 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in vena cava inferior diameter pre- and post-hydration	Change in vena cava inferior diameter (in millimetres) will be measured before and after hydration.	60 minutes
Change in vena jugularis interna diameter pre- and post-hydration (on the right side)	Change in vena jugularis interna diameter (in millimetres) will be measured before and after hydration (on the right side).	60 minutes
Change in vena jugularis interna diameter pre- and post-hydration (on the left side)	Change in vena jugularis interna diameter (in millimetres) will be measured before and after hydration (on the left side).	60 minutes
Change in collapsibility index pre- and post-hydration	Change in collapsibility index values (in per cent) will be measured before and after hydration.	60 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation to body surface area	All obtained parameters from the other Outcome Measures will be correlated to the body surface area of the patient (measured in m2)	60 minutes

Collaborators and Investigators

• Sponsor: University Hospital Ostrava
• Collaborators: University of Ostrava
• Investigators: Principal Investigator: Tomáš Zaoral, MD,PhD, University Hospital Ostrava

Publications and helpful links

General Publications

• Unluer EE, Kara PH. Ultrasonography of jugular vein as a marker of hypovolemia in healthy volunteers. Am J Emerg Med. 2013 Jan;31(1):173-7. doi: 10.1016/j.ajem.2012.07.003. Epub 2012 Sep 11.
• Bauman Z, Coba V, Gassner M, Amponsah D, Gallien J, Blyden D, Killu K. Inferior vena cava collapsibility loses correlation with internal jugular vein collapsibility during increased thoracic or intra-abdominal pressure. J Ultrasound. 2015 Sep 18;18(4):343-8. doi: 10.1007/s40477-015-0181-2. eCollection 2015 Dec.
• Lu GP, Yan G, Chen Y, Lu ZJ, Zhang LE, Kissoon N. The passive leg raise test to predict fluid responsiveness in children--preliminary observations. Indian J Pediatr. 2015 Jan;82(1):5-12. doi: 10.1007/s12098-013-1303-5. Epub 2013 Dec 11.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Actual): September 1, 2021
• Study Completion (Actual): October 1, 2021

Study Registration Dates

• First Submitted: June 15, 2020
• First Submitted That Met QC Criteria: July 7, 2020
• First Posted (Actual): July 9, 2020

Study Record Updates

• Last Update Posted (Estimate): December 7, 2022
• Last Update Submitted That Met QC Criteria: December 6, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: ultrasound; children; dehydration; vena cava inferior; vena jugularis; passive leg raise
• Additional Relevant MeSH Terms: Digestive System Diseases; Metabolic Diseases; Gastrointestinal Diseases; Acid-Base Imbalance; Acidosis; Gastroenteritis; Ketosis
• Other Study ID Numbers: FNO-OPRIP-US-fluids

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: The investigators have no plan to share individual participant data with other researchers; the data will be provided upon a written request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No