Assessment of Predictive Power for Fluid Responsiveness of Rainbow Pleth Variability Index in Children
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 45
- Primary Endpoint
- AUC of ROC curve
Study Overview
Brief Summary
The purpose of this study is to validate Rainbow pleth variability index for prediction of fluid responsiveness in children.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- — to 6 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Study group
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
Intervention: Fluid loading (Procedure)
Study group
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
Intervention: Transthoracic echocardiography (Diagnostic Test)
Study group
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
Intervention: PVI, RPVI (Diagnostic Test)
Study group
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
Intervention: Tidal volume change (Procedure)
Outcomes
Primary Outcomes
AUC of ROC curve
Time Frame: From start of anesthesia to end of anesthesia, Less than 24 hours
Area under the curve of the receiver-operating characteristics curve of pleth variability index and Rainbow pleth variability index for prediction of fluid responsiveness
Secondary Outcomes
- SpO2(From start of anesthesia to end of study, Less than 24 hours)
- Appearance of abnormal heart rhythm(From start of anesthesia to end of study, Less than 24 hours)
- IBP(From start of anesthesia to end of study, Less than 24 hours)
Investigators
Hee-Soo Kim
Professor
Seoul National University Hospital