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The purpose of this study is to validate Rainbow pleth variability index for prediction of fluid responsiveness in children.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluid loading | Procedure | Intravenous administration of 10ml/kg of crystalloids over 10 minutes |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sang-Hwan Ji, M.D., Ph.D. | Contact | +82220723661 | taepoongshin@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Hee-Soo Kim, M.D., Ph.D. | Seoul National University Hospital | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24257389 | Background | Gan H, Cannesson M, Chandler JR, Ansermino JM. Predicting fluid responsiveness in children: a systematic review. Anesth Analg. 2013 Dec;117(6):1380-92. doi: 10.1213/ANE.0b013e3182a9557e. | |
| 14523168 | Background | Han YY, Carcillo JA, Dragotta MA, Bills DM, Watson RS, Westerman ME, Orr RA. Early reversal of pediatric-neonatal septic shock by community physicians is associated with improved outcome. Pediatrics. 2003 Oct;112(4):793-9. doi: 10.1542/peds.112.4.793. |
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| ID | Term |
|---|---|
| D004452 | Echocardiography |
| ID | Term |
|---|---|
| D057791 | Cardiac Imaging Techniques |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Transthoracic echocardiography | Diagnostic Test | Transthoracic echocardiographic measurement of stroke volume index |
|
| PVI, RPVI | Diagnostic Test | Continuous measurement of pleth variability index and Rainbow pleth variability index |
|
| Tidal volume change | Procedure | Changing tidal volume for mechanical ventilation as 6, 8, 10 ml/kg |
|
| 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 |
| 11794169 | Background | Rivers E, Nguyen B, Havstad S, Ressler J, Muzzin A, Knoblich B, Peterson E, Tomlanovich M; Early Goal-Directed Therapy Collaborative Group. Early goal-directed therapy in the treatment of severe sepsis and septic shock. N Engl J Med. 2001 Nov 8;345(19):1368-77. doi: 10.1056/NEJMoa010307. |
| D014463 | Ultrasonography |
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |