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

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.

Study Overview

• Status: Recruiting
• Conditions: Anesthesia
• Intervention / Treatment: Diagnostic test: Fluid challenge (cristalloïd, NaCl 0,9%)

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pierre Pandin, MD; Phone Number: +3225555812; Email: pierre.pandin@erasme.ulb.ac.be

Study Locations

• Belgium
  • Brussels, Belgium, 1070
    • Recruiting
    • Erasmus Hospital
    • Contact: Pierre Pandin, MD; Phone Number: +3225555812; Email: pierre.pandin@erasme.ulb.ac.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 14 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 7.5 ml/kg; Group 1, receiving a fluid challenge of 7,5 ml/kg in 5 minutes	Diagnostic test: Fluid challenge (cristalloïd, NaCl 0,9%); A fluid challenge according to group will be administrated by infusion pump
Experimental: 12.5 ml/kg; Group 2, 12.5 ml/kg of fluid challenge in 5 minutes	Diagnostic test: Fluid challenge (cristalloïd, NaCl 0,9%); A fluid challenge according to group will be administrated by infusion pump

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of fluid challenge on quadricipital NIRS	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)	6 hours
Effect of fluid challenge on deltoid NIRS	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)	6 hours
Effect of fluid challenge on cerebbral NIRS	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)	6 hours

Collaborators and Investigators

• Sponsor: Erasme University Hospital
• Investigators: Study Director: Pierre Pandin, MD, Medical Doctor

Study record dates

Study Major Dates

• Study Start (Actual): October 29, 2021
• Primary Completion (Anticipated): September 30, 2023
• Study Completion (Anticipated): September 30, 2023

Study Registration Dates

• First Submitted: October 27, 2021
• First Submitted That Met QC Criteria: November 5, 2021
• First Posted (Actual): November 8, 2021

Study Record Updates

• Last Update Posted (Actual): January 23, 2023
• Last Update Submitted That Met QC Criteria: January 20, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: P2021/055/CCB B4062021000019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No