Actively Recruiting

Phase Not Applicable
Age: 1Month - 16Years
All Genders
ID05220709

Bio Impedance Monitoring as a Tool to Assess Fluid Status in the Pediatric Surgical Patient: Can we Measure a Fluid Shift

Led by University Hospital, Antwerp · Updated on 2025-03-05

100

Participants Needed

1

Research Sites

21 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the use of bio impedance spectroscopy to monitor fluid shifts in children undergoing surgery under general anesthesia. The study addresses whether the traditional 'Holliday and Segar' rule for fluid infusion rates during surgery is outdated, given it was based on caloric needs from cow milk. This pilot study aims to validate bio impedance measurements as a tool to assess fluid status in pediatric surgical patients. The study uses the Body Composition Monitor (BCM), a device that non-invasively measures body fluid compartments by sending low and high-frequency electrical currents through the body. Electrodes are placed on the hands and feet to gather data, which is analyzed to determine total body water and extracellular water volumes. Measurements are taken before surgery and after surgery at different time points depending on if the child is an outpatient or inpatient. The device provides results within two minutes and is supervised by trained staff. Participants will have their age, gender, height, weight, and blood pressure recorded before measurement. For outpatients, measurements occur preoperatively and postoperatively before IV removal. For inpatients, measurements happen preoperatively, then at 6 hours and 24 hours after anesthesia induction. Data collected includes total body water changes to assess fluid shifts. The study does not require further follow-up after hospital discharge. Only high-quality measurements are used for analysis, and the study is conducted under standard anesthesia care protocols.

CONDITIONS

Brief Title

Bio Impedance Monitoring as a Tool to Assess Fluid Status in the Pediatric Surgical Patient? (PedFluid Study)

Who Can Participate

Age: 1Month - 16Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Scheduled for elective surgery or investigation under general anesthesia
  • Day care or inpatient hospitalisation
Not Eligible

You will not qualify if you...

  • Sedation needed instead of general anesthesia
  • Critically ill patients requiring urgent surgery
  • Inability to lie still for bio impedance measurements
  • No informed consent obtained from parent or guardian

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Diagnostic Evaluation

Duration - Day of surgery

Participants undergo bio impedance spectroscopy measurements using the Body Composition Monitor to assess fluid status before and after surgery.

1 preoperative measurement and 1 to 2 postoperative measurements depending on inpatient or daycare status

Trial Site Locations

Total: 1 location

1

Antwerp University Hospital

Edegem, Antwerp, Belgium, 2650

Actively Recruiting

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Research Team

V

Vera Saldien, MD, PhD

J

Joke De Wachter

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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