Prediction of Fluid Responsiveness in Children Undergoing Major Surgery

Study Overview
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Brief Summary
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The purpose of this study is to evaluate predictability of a respiratory variation in pulse oximeter plethysmography for fluid responsiveness in children undergoing major surgery.

Detailed Description
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The purpose of this study is to evaluate predictability of a a respiratory variation in pulse oximeter plethysmography (delta POP) for fluid responsiveness in children undergoing major surgery. When there are clinical signs of hypovolemia, such as hypotension, decreased urine output and central venous pressure less than 5 mmHg, the study will be started. At index fingers of both hand, pulse oximeter sensors are applied by gradually increasing the contact force (from 0 to 1.4N, being increased by 0.2-0.3N). Then, pulse oximeter plethysmography (POP) waveforms are obtained for 90 seconds. Then, intravenous crystalloid fluid 10 mL/kg is infused for 15 min. To evaluate the change of cardiac output, transesophageal or transthoracic echocardiography is performed before and after fluid administration. In addition, hemodynamic parameters including pulse pressure variation, systolic pressure variation, pleth variability index and central venous pressure are also recorded before and after fluid administration. Finally, patients will be divided into fluid responder group and non-responder group. If stroke volume index measured using echocardiography increases over 15% after fluid administration, the patient will be fluid responder. Delta POP (%) obtained from each finger with different contact force is calculated as follows;(POPmax - POPmin)/{(POPmax + POPmin)/2}. Using receiver operating characteristic curve, diagnostic power of delta POPs from different contact forces for fluid responsiveness will be evaluated. In addition, difference between delta POP from low contact force and that from high contact force will be evaluated.

Official Title
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Prediction of Fluid Responsiveness Using Respiratory Variation in Pulse Oximeter Plethysmography in Children Undergoing Major Surgery

Conditions
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Hypovolemia

Intervention / Treatment
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* Procedure: Pulse oximeter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Children who will be scheduled for major surgery requiring invasive hemodynamic monitoring Exclusion Criteria: renal, hepatic and pulmonary disease preoperative infection: increased C-reactive protein, whith blood cell count over 10,000, and with fever genetic and hematologic disease ventricular dysfunction increased intracranial pressure

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Children with hypovolemic state<br>Pulse oximeter plethysmography (POP) waveforms are obtained for 90 seconds in children with hypovolemic signs including hypotension, decreased urine output and central venous pressure less than 5 mmHg. Then, intravenous crystalloid fluid 10 mL/kg is infused for 15 min. Delta POP is calculated, and diagnostic power of delta POP for fluid responsiveness will be evaluated. | Procedure: Pulse oximeter<br>* When there are clinical signs of hypovolemia, such as hypotension, decreased urine output and central venous pressure less than 5 mmHg, POP waveforms are obtained from each index finger, which pulse oximeter sensor is applied by increasing contact force (from 0 to 1.4N, being increased by 0.2-0.3N). Then intravenous crystalloid 10 mL/kg is infused for 15 min.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The ability of delta POP for prediction of fluid responsiveness in children | Delta POP (%) obtained from each finger with different contact force is calculated as follows;(POPmax - POPmin)/{(POPmax + POPmin)/2}. Delta POP differs according to contact force. After calculation of each delta POP, we will evaluate the ability to predict fluid responsiveness of delta POP using receiver operating characteristic curve. | Before and after fluid administration (total 20 min) |