Clinical trial NCT04463082: Non-invasive Assessment of the Current State of Hydration in Children by Ultrasound
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastroenteritis
Diabetes Mellitus (Ketoacidosis)
Keywords: children
dehydration
ultrasound
vena cava inferior
vena jugularis
passive leg raise
Lead sponsor: University Hospital Ostrava
Sponsor class: OTHER
Collaborators: name: University of Ostrava
First posted: 2020-07-09
Enrollment: 30
Sex: ALL
Minimum age (years): 1
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The pediatric patients will be divided into three groups, according to weight: 10-20kg, 20-30kg, 30-50kg.
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in vena cava inferior diameter pre- and post-hydration
timeFrame: 60 minutes
measure: Change in vena jugularis interna diameter pre- and post-hydration (on the right side)
timeFrame: 60 minutes
measure: Change in vena jugularis interna diameter pre- and post-hydration (on the left side)
timeFrame: 60 minutes
measure: Change in collapsibility index pre- and post-hydration
timeFrame: 60 minutes
Secondary outcomes:
measure: Correlation to body surface area
timeFrame: 60 minutes
Other outcomes:
Locations:
city: Ostrava
country: Czechia
facility: University Hospital Ostrava
state: Moravian-Silesian Region
Study officials:
affiliation: University Hospital Ostrava
name: Tomáš Zaoral, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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.