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

Gastroenteritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04463082
• Other study ID #: FNO-OPRIP-US-fluids
• Status: Completed
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: October 1, 2021

Study information

• Verified date: December 2022
• Source: University Hospital Ostrava
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 1, 2021
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus (Ketoacidosis)
• Gastroenteritis
• Ketosis

Intervention

Procedure:
• Intravenous administration of fluids
Intravenous administration of fluids (20ml/kg, but the maximum volume will be limited up to 500ml) within 60 minutes.

Locations

Country	Name	City	State
Czechia	University Hospital Ostrava	Ostrava	Moravian-Silesian Region

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Ostrava	University of Ostrava

Country where clinical trial is conducted

Czechia, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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