Anesthesia, Fluid Responsiveness
Conditions
Keywords
Fluid responsiveness, pleth variability index
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.
Interventions
PROCEDUREFluid loading
Intravenous administration of 10ml/kg of crystalloids over 10 minutes
DIAGNOSTIC_TESTTransthoracic echocardiography
Transthoracic echocardiographic measurement of stroke volume index
DIAGNOSTIC_TESTPVI, RPVI
Continuous measurement of pleth variability index and Rainbow pleth variability index
PROCEDURETidal volume change
Changing tidal volume for mechanical ventilation as 6, 8, 10 ml/kg
Sponsors
Seoul National University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 6 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUC of ROC curve | 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
| Measure | Time frame | Description |
|---|---|---|
| SpO2 | From start of anesthesia to end of study, Less than 24 hours | Pulse oximetry during the study for monitoring whether hypoxia appears. |
| Appearance of abnormal heart rhythm | From start of anesthesia to end of study, Less than 24 hours | 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. |
| IBP | From start of anesthesia to end of study, Less than 24 hours | 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. |
Contacts
Primary ContactSang-Hwan Ji, M.D., Ph.D.
Outcome results
None listed