Bio Impedance Monitoring as a Tool to Assess Fluid Status in the Pediatric Surgical Patient? (PedFluid Study)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-16
SponsorUniversity Hospital, Antwerp
About this trial
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patients still is the 'Holliday and Segar' rule (also known as the 4/2/1 rule) The question arises if this rule is not outdated, since it was calculated based on the caloric need of the pediatric population, calculated for cow milk.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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Scheduled for elective surgery or investigation under general anesthesia
Day care or inpatient hospitalisation
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
bio impedance spectroscopy by means of the Body Composition Monitor (Name of the device is BCM from Fresenius Medical Care D GmbH)
Diagnostic testThe 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.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Bio impedance spectroscopy in children scheduled for elective surgery under general anesthesiaOther 1 intervention
Trial outcomes
Primary outcomes
1
total body water
sum of intracellular water and extracellular water, calculated in liter
Time frame
measurements with BCM will be done pre-surgery2
total body water
sum of intracellular water and extracellular water, calculated in liter
Time frame
measurements with BCM will be done within 6 hours post-surgery for patients in day care3
total body water
sum of intracellular water and extracellular water, calculated in liter
Time frame
measurements with BCM will be done within 24 hours post-surgery for hospitalized patientsSponsors and contacts
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Source ClinicalTrials.gov