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

NCT ID: NCT05111132

Last Updated: 2023-01-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-29
• Study Completion Date: 2023-09-30

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.

Conditions

Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

7.5 ml/kg

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

Group Type: EXPERIMENTAL

Fluid challenge (cristalloïd, NaCl 0,9%)

Intervention Type: DIAGNOSTIC_TEST

A fluid challenge according to group will be administrated by infusion pump

12.5 ml/kg

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

Group Type: EXPERIMENTAL

Fluid challenge (cristalloïd, NaCl 0,9%)

Intervention Type: DIAGNOSTIC_TEST

A fluid challenge according to group will be administrated by infusion pump

Interventions

Fluid challenge (cristalloïd, NaCl 0,9%)

A fluid challenge according to group will be administrated by infusion pump

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Erasme University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Lulia Scolobiuc

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pierre Pandin, MD

Role: STUDY_DIRECTOR

Medical doctor

Locations

Erasmus Hospital

Brussels, , Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Pierre Pandin, MD

Role: CONTACT

Pierre.Pandin@erasme.ulb.ac.be

+3225555812

Facility Contacts

Pierre Pandin, MD

Role: primary

pierre.pandin@erasme.ulb.ac.be

+3225555812

Other Identifiers

P2021/055/CCB B4062021000019

Identifier Type: -

Identifier Source: org_study_id