RPVI for Fluid Responsiveness in Children

Study Overview
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Brief Summary
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The purpose of this study is to validate Rainbow pleth variability index for prediction of fluid responsiveness in children.

Detailed Description
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Children undergoing surgery under general anesthesia will be enrolled. After anesthetic induction, they will be assessed via transthoracic echocardiography for measurement of the patient's stroke volume index (SVI). Also, pleth variability index and Rainbow pleth variability index will be measured under mechanical ventilation with tidal volume of 6, 8, 10 ml/kg. To exert fluid loading, 10ml/kg of crystalloid solution will be administered intravenously over 10 minutes. After fluid loading, the SVI will be measured again and fluid responsiveness will be determined according to increment ratio of the SVI. According to the determined fluid responsiveness, predictive power of pleth variability index and Rainbow pleth variability index for fluid responsiveness will be assessed by building a receiver-operating characteristics curve.

Official Title
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Assessment of Predictive Power for Fluid Responsiveness of Rainbow Pleth Variability Index in Children

Conditions
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Anesthesia, Fluid Responsiveness

Intervention / Treatment
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* Procedure: Fluid loading
* Diagnostic Test: Transthoracic echocardiography
* Diagnostic Test: PVI, RPVI
* Procedure: Tidal volume change


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children undergoing neurosurgery under general anesthesia Exclusion Criteria: Presence of any cardiovascular disease Presence of any pulmonary disease Decline of enrollment from any of the patient's parents

Ages Eligible for Study
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Maximum Age: 6 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: Study group<br>Fluid loading, Stroke volume index measurement via transthoracic echocardiography, measurement of pleth variability index and Rainbow pleth variability index, change of tidal volume under mechanical ventilation | Procedure: Fluid loading<br>* Intravenous administration of 10ml/kg of crystalloids over 10 minutes<br>Diagnostic Test: Transthoracic echocardiography<br>* Transthoracic echocardiographic measurement of stroke volume index<br>Diagnostic Test: PVI, RPVI<br>* Continuous measurement of pleth variability index and Rainbow pleth variability index<br>Procedure: Tidal volume change<br>* Changing tidal volume for mechanical ventilation as 6, 8, 10 ml/kg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC of ROC curve | Area under the curve of the receiver-operating characteristics curve of pleth variability index and Rainbow pleth variability index for prediction of fluid responsiveness | From start of anesthesia to end of anesthesia, Less than 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Appearance of abnormal heart rhythm | Electrocardiogram during the study for monitoring whether tachycardia, bradycardia, or arrhythmia appears. Heart rate will be compared between patients who were fluid responsive and who were not responsive. | From start of anesthesia to end of study, Less than 24 hours | 
| IBP | Invasive blood pressure during the study, including systolic, diastolic, mean blood pressure for monitoring whether hypertension or hypotension appears. Mean blood pressure will be compared between patients who were fluid responsive and who were not responsive. | From start of anesthesia to end of study, Less than 24 hours | 
| SpO2 | Pulse oximetry during the study for monitoring whether hypoxia appears. | From start of anesthesia to end of study, Less than 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fluid responsiveness, pleth variability index