Can Peripheral NIRS Predict the Response to a Fluid Challenge in Pediatric Patients: An Interventional Study

Free University of Brussels (ULB)

Status: Enrolling

Conditions: Anesthesia

Treatments: Diagnostic Test: Fluid challenge (cristalloïd, NaCl 0,9%)

Study type: Interventional

Funder types: Other

Identifiers

NCT05111132

P2021/055/CCB B4062021000019

Details and patient eligibility

About

This study will be conducted on pediatric patients up to 14 years of age. The effect of two fluid challenge regimes on cerebral and peripheral NIRS will be assessed, in a randomized double blinded controlled trial. The findings will be correlated with two ultrasound measures, previously validated as markers of fluid responsiveness.

Full description

The patients will be recruited during the preoperative consultation. After inhalational induction and placement of all monitors, an intravenous access is established. After induction and securing of the airway via endotracheal tube or laryngeal mask, we note the reference values of all parameters. A pre-fluid challenge ultrasound is done, to assess the inferior vena cava distensibillity index, and the Vmax aortic peak flow velocity. After this the fluid challenge is performed. The second ultrasound measures are done after the fluid challenge. Finally an ultrasound is performed at the end of the operation, before emergence, to assess wether the standard peroperative fluid therapy has affecter these measures. NIBP, SpO2, HR, RR, NIRS values will be noted throughout the whole perioperative period. THe end-goald is to correlate the ultrasound findings to the NIRS-values, and see wether the NIRS can be used as a monitor of fluid therapy in pediatric patients.

Enrollment: 30 estimated patients

Sex: All

Ages: 1 to 14 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• all operations excepting cardiac surgery
• BMI < 30
• ages 1-14 years

Exclusion criteria

• any cardiac affection (congenital unoperated heart disease, arrythmias)
• icterus
• refusal

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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30 participants in 2 patient groups

7.5 ml/kg

Experimental group

Description:

Group 1, receiving a fluid challenge of 7,5 ml/kg in 5 minutes

Treatment:

Diagnostic Test: Fluid challenge (cristalloïd, NaCl 0,9%)

12.5 ml/kg

Experimental group

Description:

Group 2, 12.5 ml/kg of fluid challenge in 5 minutes

Treatment:

Diagnostic Test: Fluid challenge (cristalloïd, NaCl 0,9%)