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

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05111132
• Other study ID #: P2021/055/CCB B4062021000019
• Status: Recruiting
• Phase: N/A
• Start date: October 29, 2021
• Est. completion date: September 30, 2023

Study information

• Verified date: January 2023
• Source: Erasme University Hospital
• Contact: Pierre Pandin, MD
• Phone: +3225555812
• Email: Pierre.Pandin[@]erasme.ulb.ac.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year to 14 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia

Intervention

Diagnostic Test:
• Fluid challenge (cristalloïd, NaCl 0,9%)
A fluid challenge according to group will be administrated by infusion pump

Locations

Country	Name	City	State
Belgium	Erasmus Hospital	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Erasme University Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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