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

Primary Purpose

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

Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
bio impedance spectroscopy by means of the Body Composition Monitor (Name of the device is BCM from Fresenius Medical Care D GmbH)
Sponsored by
University Hospital, Antwerp
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Fluid and Electrolyte Imbalance focused on measuring bio impedance spectroscopy

Eligibility Criteria

1 Month - 16 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Sites / Locations

  • Antwerp University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

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

Arm Description

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

Outcomes

Primary Outcome Measures

total body water
sum of intracellular water and extracellular water, calculated in liter
total body water
sum of intracellular water and extracellular water, calculated in liter
total body water
sum of intracellular water and extracellular water, calculated in liter

Secondary Outcome Measures

Full Information

First Posted
December 6, 2021
Last Updated
May 30, 2023
Sponsor
University Hospital, Antwerp
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1. Study Identification

Unique Protocol Identification Number
NCT05220709
Brief Title
Bio Impedance Monitoring as a Tool to Assess Fluid Status in the Pediatric Surgical Patient? (PedFluid Study)
Official Title
Bio Impedance Monitoring as a Tool to Assess Fluid Status in the Pediatric Surgical Patient: Can we Measure a Fluid Shift
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 5, 2022 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Antwerp

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
The Body Composition Monitor (BCM, Fresenius Medical Care, Germany) is the first device that determines individual fluid status and body composition in an easy and objective way. The technology uses bioimpedance spectroscopy (BIS) to determine total body water (TBW) and extracellular water volume (ECW).It measures at 50 frequencies over a range from 5 to 1000 kHz to determine the electrical resistances of the total body water and the extracellular water. While high-frequency current passes through the total body water, low-frequency current cannot penetrate cell membranes and thus flows exclusively through the extracellular water. To obtain the clinically relevant output parameters, two advanced physiological models are used in the BCM: a volume model, describing electrical conductance in a cell suspension enabling the total body water and extracellular water as well as the intracellular water (ICW) to be calculated, and a body composition model calculating the three principal body compartments overhydration, lean tissue and adipose tissue from ECW and TBW information. The measurement is a non-invasive and accurate method that is easy to apply and results are obtained within just two minutes. It has been extensively used in patients with kidney disease receiving dialysis, both in adult and pediatric patients. However, bio impedance spectrometry has not yet been tested in the perioperative setting. This is a single-center pilot study to evaluate if bio impedance measurement is a workable tool to determine fluid shifts in the pediatric population after a surgical procedure was performed under general anesthesia. Patients will be seen preoperatively by an anesthesiologist which is standard of care upon surgery under general anesthesia and eligibility will be evaluated. Informed consent will be asked and has to be signed by the accompanying parent or legal guardian. Where possible, care will be taken to inform the child itself about the content of the study and to get a written acknowledge. There are no other investigations necessary for this research. All patients on the day of surgery will be fasted as by the guidelines of the European Society of Anesthesia. For patients in daycare surgery, measurements with BCM will be performed preoperatively and postoperatively before ending the IV line on the ward. For inpatient hospitalisation, measurements by BCM will be performed preoperatively, postoperatively 6 hours after induction and postoperatively 24 h after induction.. 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 and only good quality measurements will be used. Data are collected on chip cards by the BCM. Data can be transferred to a personal computer for further analysis with the Fluid Management Tool (FMT). Site requirements is the availability of a low electronic surrounding for correct measurement. After discharge of the hospital no further follow up assessments regarding this study are needed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fluid and Electrolyte Imbalance, Body Weight Changes, Children, Only
Keywords
bio impedance spectroscopy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Bio impedance spectroscopy in children scheduled for elective surgery under general anesthesia
Arm Type
Other
Arm Description
All subjects receive bio impedance monitor measurements pre operatively and post operatively.
Intervention Type
Diagnostic Test
Intervention Name(s)
bio impedance spectroscopy by means of the Body Composition Monitor (Name of the device is BCM from Fresenius Medical Care D GmbH)
Intervention Description
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.
Primary Outcome Measure Information:
Title
total body water
Description
sum of intracellular water and extracellular water, calculated in liter
Time Frame
measurements with BCM will be done pre-surgery
Title
total body water
Description
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 care
Title
total body water
Description
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 patients

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Scheduled for elective surgery or investigation under general anesthesia Day care or inpatient hospitalisation Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vera Saldien, MD, PhD
Phone
38214788
Ext
0032
Email
vera.saldien@uza.be
First Name & Middle Initial & Last Name or Official Title & Degree
Joke De Wachter
Phone
38213042
Ext
0032
Email
joke.dewachter@uza.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vera Saldien, MD,PhD
Organizational Affiliation
University Hospital, Antwerp
Official's Role
Principal Investigator
Facility Information:
Facility Name
Antwerp University Hospital
City
Edegem
State/Province
Antwerp
ZIP/Postal Code
2650
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vera Saldien, MD, PhD
Phone
38214788
Ext
0032
Email
vera.saldien@uza.be
First Name & Middle Initial & Last Name & Degree
Joke De Wachter
Phone
38213042
Ext
0032
Email
joke.dewachter@uza.be

12. IPD Sharing Statement

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

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