Children, Only Clinical Trial
Official title:
Bio Impedance Monitoring as a Tool to Assess Fluid Status in the Pediatric Surgical Patient: Can we Measure a Fluid Shift
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patients still is the 'Holliday and Segar' rule (also known as the 4/2/1 rule) The question arises if this rule is not outdated, since it was calculated based on the caloric need of the pediatric population, calculated for cow milk.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.
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. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT03781817 -
Intranasal Versus Intravenous Ketamine for Procedural Sedation in Children With Non-operative Fractures
|
Phase 4 | |
Recruiting |
NCT05424757 -
Polyethylene Glycol Safety in Children
|
||
Recruiting |
NCT04602429 -
Children's Acute Surgical Abdomen Programme
|
||
Recruiting |
NCT05378581 -
Use of Virtual Reality Mask During Blood and Skin Allergic Tests in 7 to 13 Children
|
N/A | |
Completed |
NCT04933734 -
Turkish Cultural Adaptation, Validity and Reliability of the "Physical Activity-Specific Rumination Scale for Children"
|
||
Completed |
NCT03457688 -
Effect of Prebiotic Fructans to Reduce Number of Febrile Infections in Children
|
N/A | |
Recruiting |
NCT05113420 -
The Efficacy and Safety of Different Phlebotonic Drugs in Children With Venous Malformations
|
||
Completed |
NCT03241355 -
Prebiotic Fructans on the Incidence of Acute Infectious Diseases in Children
|
N/A | |
Not yet recruiting |
NCT05484102 -
Preventive Effect of Cow's Milk Fermented With Lactobacillus Paracasei CBA L74 on Common Infectious Diseases in Children
|
N/A | |
Recruiting |
NCT04460313 -
Nasopharyngeal Carriage of S. Pneumoniae
|
N/A | |
Not yet recruiting |
NCT05974917 -
Serious gaMes as Emerging E-health Interventions for Young People With neurologicaL or rEspiratory disoRders
|
||
Completed |
NCT06451289 -
Study on Optic Nerve Sheath Diameter Measurements in Prolonged Pediatric Seizures
|
||
Completed |
NCT04057612 -
Correlation Between Core Temperature and Skin Temperature in Pediatrics
|
||
Completed |
NCT04256590 -
Tongue Depressor-related Tongue Swelling
|
||
Recruiting |
NCT03319927 -
Reducing Pesticide Exposures in Child Care Centers
|
N/A | |
Enrolling by invitation |
NCT05513235 -
Feasibility Study of a Mobile Digital Personal Health Record for Family-Centered Care Coordination for Children and Youth With Special Healthcare Needs
|
N/A | |
Completed |
NCT04615000 -
SeroCovid<19: Covid-19 Seroconversion in Tertiary Pediatric Patients
|
||
Not yet recruiting |
NCT05568849 -
Optical Coherence Tomography Angiography (OCTA) in Children's Cardiac Surgery
|
N/A | |
Recruiting |
NCT06157346 -
Characteristics of Intestinal Bacteria and Their Effects on Growth and Immune Function in Children at High Altitude
|
||
Recruiting |
NCT04206956 -
Anxiety and Chronic Postsurgical Pain Following Ambulatory Surgery in Children
|