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

Not Applicable

Recruiting

• Conditions: Anesthesia
• Interventions: Diagnostic Test: Fluid challenge (cristalloïd, NaCl 0,9%)

• Registration Number: NCT05111132
• Lead Sponsor: Erasme University Hospital

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2021-10-27
• Study Start: 2021-10-29
• Study First Submitted QC: 2021-11-05
• Study First Posted: 2021-11-08
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-20
• Last Update Posted: 2023-01-23
• Primary Completion: 2023-09-30
• Study Completion: 2023-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
12.5 ml/kg	Fluid challenge (cristalloïd, NaCl 0,9%)	Group 2, 12.5 ml/kg of fluid challenge in 5 minutes
7.5 ml/kg	Fluid challenge (cristalloïd, NaCl 0,9%)	Group 1, receiving a fluid challenge of 7,5 ml/kg in 5 minutes

Primary Outcome Measures

Name	Time	Method
Effect of fluid challenge on deltoid NIRS	6 hours	We will assess the effect of fluid challenge on muscular deltoid NIRS in correlation with validated parameters for fluid therapy (dynamic parameters measured by ultrasound: IVC distensibility indec, Vmax aorta)
Effect of fluid challenge on cerebbral NIRS	6 hours	We will assess the effect of fluid challenge on cerebral NIRS in correlation with validated parameters for fluid therapy (dynamic parameters measured by ultrasound: IVC distensibility indec, Vmax aorta)
Effect of fluid challenge on quadricipital NIRS	6 hours	We will assess the effect of fluid challenge on muscular quadricipital in correlation with validated parameters for fluid therapy (dynamic parameters measured by ultrasound: IVC distensibility indec, Vmax aorta)

Trial Locations

Locations (1)

Erasmus Hospital; 🇧🇪 Brussels, Belgium