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

NCT05220709 | Recruiting

• 2 other identifiers: 2021-0576002090
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The baseline infusion rate during surgery for pediatric patients still is the 'Holliday and Segar' rule (also known as the 4/2/1 rule) The question arises if this rule is not outdated, since it was calculated based on the caloric need of the pediatric population, calculated for cow milk. The study tends to validate the use of bio impedance measurements for registering fluid shifts in the pediatric surgical patients.

Conditions

Fluid and Electrolyte Imbalance; Body Weight Changes; Children, Only

Keywords

bio impedance spectroscopy

Outcome Measures

Primary Outcomes (3)

• total body water

  sum of intracellular water and extracellular water, calculated in liter

  measurements with BCM will be done pre-surgery

• total body water

  sum of intracellular water and extracellular water, calculated in liter

  measurements with BCM will be done within 6 hours post-surgery for patients in day care

• total body water

  sum of intracellular water and extracellular water, calculated in liter

  measurements with BCM will be done within 24 hours post-surgery for hospitalized patients

Study Arms (1)

Bio impedance spectroscopy in children scheduled for elective surgery under general anesthesia

OTHER

All subjects receive bio impedance monitor measurements pre operatively and post operatively.

Diagnostic Test: bio impedance spectroscopy by means of the Body Composition Monitor (Name of the device is BCM from Fresenius Medical Care D GmbH)

Interventions

bio impedance spectroscopy by means of the Body Composition Monitor (Name of the device is BCM from Fresenius Medical Care D GmbH) DIAGNOSTIC_TEST

The Body Composition Monitor provides information about the hydration status by a bioimpedance spectroscopy measurement of the body composition from which the level of overhydration can be derived. Four electrodes are used per measurement. All subjects get electrodes attached, following the wrist-ankle approach, in a tetrapolar arrangement. Two electrodes are placed on the hand: one on the wrist, and the second on the dorsal side of the metacarpalia, close to the phalanges. The other two electrodes are placed on the foot: one on the ankle, and the second on the dorsal side of the metatarsals, close to the phalanges of the toes. Age, gender, height, weight and blood pressure are registered in the device before starting the measurement. If the quality calculated by BCM is \< 60%, the measurement will be repeated again. Measurements are taken under supervision of a trained technician or nurse.

Bio impedance spectroscopy in children scheduled for elective surgery under general anesthesia

Eligibility Criteria

• Age: 1 Month - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Scheduled for elective surgery or investigation under general anesthesia
• Day care or inpatient hospitalisation

You may not qualify if:

• If sedation is needed instead of general anesthesia
• Critically ill patients for urgent surgery
• Patients who cannot lie still for performing correct measurements on the bio impedance monitor
• No informed consent obtained

Sponsors & Collaborators

• University Hospital, Antwerp: lead

Study Sites (1)

Antwerp University Hospital

Edegem, Antwerp, 2650, Belgium

RECRUITING

MeSH Terms

Conditions

Body Weight Changes

Condition Hierarchy (Ancestors)

Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Vera Saldien, MD,PhD

  University Hospital, Antwerp

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vera Saldien, MD, PhD

CONTACT

38214788; vera.saldien@uza.be

Joke De Wachter

CONTACT

38213042; joke.dewachter@uza.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is a single-centre pilot study to evaluate the feasibility of bio impedance measurements to determine fluid shifts in the pediatric population after a surgical procedure was performed.

Study Record Dates

• First Submitted: December 6, 2021
• First Posted: February 2, 2022
• Study Start: April 5, 2022
• Primary Completion: December 30, 2025
• Study Completion (Estimated): May 31, 2026
• Last Updated: March 5, 2025

Record last verified: 2025-03

Locations

BE (1)